PROPYLPARABEN
UNII Z8IX2SC1OH

Substance Identification & Data

This profile provides standardized clinical and technical data for Propylparaben, uniquely identified by the FDA Unique Ingredient Identifier (UNII) Z8IX2SC1OH.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 94-13-3 and the RxNorm Concept ID (RxCUI) 34706. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
Z8IX2SC1OH
CAS Registry Number
94-13-3
RxNorm Concept ID
34706

Detailed Substance Profile

Preferred Name
PROPYLPARABEN
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
Z8IX2SC1OH
The specific atomic composition represented as a molecular structure string.
InChIKey
C10H12O3
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
QELSKZZBTMNZEB-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C76730
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
7175
Unique identification number in the NCBI database of chemical substances.
USAN ID
Y-36
Identifier assigned by the United States Adopted Names Council.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
C(c1ccc(cc1)O)(=O)OCCC

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Propylparaben. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

PROPYLPARABEN

Common Names & Synonyms

BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER
METHYL PARAHYDROXYBENZOATE IMPURITY C [EP IMPURITY]
PROPYL HYDROXYBENZOATE [MART.]
PROPYL HYDROXYBENZOATE [WHO-IP]
PROPYL PARABEN [VANDF]
PROPYL PARA-HYDROXYBENZOATE
PROPYL PARAHYDROXYBENZOATE [EP IMPURITY]
PROPYL PARAHYDROXYBENZOATE [EP MONOGRAPH]
PROPYL PARAHYDROXYBENZOATE [JAN]
PROPYL P-HYDROXYBENZOATE
PROPYL P-HYDROXYBENZOATE [FHFI]
PROPYLIS HYDROXYBENZOAS [WHO-IP LATIN]
PROPYLPARABEN [FCC]
PROPYLPARABEN [HSDB]
PROPYLPARABEN [II]
PROPYLPARABEN [MI]
PROPYLPARABEN [USAN]
PROPYLPARABEN [USP-RS]
PROPYLPARABEN [VANDF]
PROPYLPARABEN [WHO-DD]
PROPYLPARABEN E216
TEGOSEPT P

Brand / Trade Names

NIPAGIN P
NIPASOL
NIPAZOL
PARABEN P
PARATEXIN P
PROPAGIN

Systematic Nomenclature

PROPYL (4-HYDROXYBENZOATE)
PROPYL HYDROXYBENZOATE
PROPYL PARAHYDROXYBENZOATE

Technical Codes

FEMA NO. 2951
NSC-23515
NSC-8511

NDC Products Containing PROPYLPARABEN

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

Manufacturer Quick Index

Note: Due to the high number of listings (500), only Active Listings are currently displayed. Display is limited to the first 200 products.
→ Actavis Pharma, Inc. 6
→ BF ASCHER AND CO INC 1
→ Bausch Health US LLC 1
→ Bausch Health US, LLC 7
→ Bayer HealthCare LLC. 6
→ Bracco Diagnostics Inc 1
→ C.B. Fleet Company, Inc. 3
→ E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 1
→ E.R. Squibb & Sons, L.L.C. 1
→ Galderma Laboratories, L.P. 3
→ Haleon US Holdings LLC 21
→ Hikma Pharmaceuticals USA Inc. 25
→ Hikma Pharmaceuticals USA, Inc. 8
→ L. Perrigo Company 8
→ Merck Sharp & Dohme LLC 1
→ Merz Pharmaceuticals, LLC 1
→ Mission Pharmacal Company 5
→ Novartis Pharmaceuticals Corporation 1
→ PAI Holdings, LLC 2
→ PAI Holdings, LLC dba PAI Pharma 30
→ Par Health USA, LLC 1
→ Parke-Davis Div of Pfizer Inc 1
→ Pharmaceutical Associates, Inc. 3
→ Pharmacia & Upjohn Company LLC 4
→ Teva Pharmaceuticals USA Inc. 1
→ Teva Pharmaceuticals USA, Inc. 10
→ Trividia Manufacturing Solutions, Inc 2
→ Viatris Specialty LLC 4
→ WALGREEN COMPANY 5
→ WALGREENS 1
→ Walgreen Co. 3
→ Walgreen Company 13
→ Walgreens 13
→ Walgreens Co. 1
→ Walgreens Company 1
→ West-Ward Pharmaceuticals Corp 2
→ Xttrium Laboratories, Inc 1
→ Xttrium Laboratories, Inc. 2

Actavis Pharma, Inc.

NDC Product
Drug For Further Processing

NDC 0228-2067

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Oxazepam
NDC 0228-2067

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Oxazepam
NDC 0228-2069

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0228-2069

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0228-2073

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Oxazepam
NDC 0228-2073

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
ANDA
Active Listing

BF ASCHER AND CO INC

NDC Product
Human Otc Drug

Itch X
NDC 0225-0495

Generic Name
Benzyl Alcohol/pramoxine Hydrochloride
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bausch Health US LLC

NDC Product
Human Prescription Drug

Renova
NDC 0187-5150

Generic Name
Tretinoin
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing

Bausch Health US, LLC

NDC Product
Human Prescription Drug

Bryhali
NDC 0187-0002

Generic Name
Halobetasol Propionate
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Duobrii
NDC 0187-0653

Generic Name
Halobetasol Propionate And Tazarotene
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Arazlo
NDC 0187-2098

Generic Name
Tazarotene
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Efudex
NDC 0187-3204

Generic Name
Fluorouracil
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noritate
NDC 0187-5202

Generic Name
Metronidazole
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Caladryl
NDC 0187-5465

Generic Name
Ferric Oxide Red, Zinc Oxide, And Pramoxine Hydrochloride
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Caladryl Clear
NDC 0187-5466

Generic Name
Pramoxine Hydrochloride And Zinc Acetate
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bayer HealthCare LLC.

NDC Product
Human Otc Drug

Alka-seltzer Kids Tummy Reliefchews
NDC 0280-0051

Generic Name
Calcium Carbonate And Dimethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Alka-seltzer Heartburn Reliefchews
NDC 0280-0221

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bracco Diagnostics Inc

NDC Product
Human Prescription Drug

Choletec
NDC 0270-0083

Generic Name
Mebrofenin
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing

C.B. Fleet Company, Inc.

NDC Product
Human Otc Drug

Pedia-lax
NDC 0132-0113

Generic Name
Docusate Sodium
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Fleet
NDC 0132-0401

Generic Name
Bisacodyl
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Fleet
NDC 0132-0703

Generic Name
Bisacodyl
Dosage Form
Enema
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Adapalene
NDC 0168-0424

Generic Name
Adapalene
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing

E.R. Squibb & Sons, L.L.C.

NDC Product
Human Prescription Drug

Baraclude
NDC 0003-1614

Generic Name
Entecavir
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

Galderma Laboratories, L.P.

NDC Product
Human Prescription Drug

Soolantra
NDC 0299-3823

Generic Name
Ivermectin
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Cetaphil Cracked Skin Repair
NDC 0299-4114

Generic Name
Dimethicone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Tri-luma
NDC 0299-5950

Generic Name
Fluocinolone Acetonide, Hydroquinone, And Tretinoin
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8655

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8753

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8754

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8755

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Gas-x Total Relief Maximum Strength
NDC 0067-0118

Generic Name
Calcium Carbonate, Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gas-x Total Relief Maximum Strength
NDC 0067-0119

Generic Name
Calcium Carbonate, Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Perdiem
NDC 0067-8143

Generic Name
Sennosides, Stimulant Laxative
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0183

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Berry Shake
NDC 0135-0184

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Raspberry Lemonade
NDC 0135-0188

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Abreva Rapid Pain Relief
NDC 0135-0400

Generic Name
Glycerin, Lidocaine
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0606

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0618

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites With Gas Relief
NDC 0135-0624

Generic Name
Calcium Carbonate And Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Mixed Fruit
NDC 0135-0641

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Orange And Cream Es
NDC 0135-0642

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Digoxin
NDC 0054-0057

Generic Name
Digoxin
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Citalopram
NDC 0054-0062

Generic Name
Citalopram
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Galantamine Hydrobromide
NDC 0054-0137

Generic Name
Galantamine Hydrobromide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Alendronate Sodium
NDC 0054-0282

Generic Name
Alendronate Sodium
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Hydromorphone Hydrochloride
NDC 0054-0386

Generic Name
Hydromorphone Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Rufinamide
NDC 0054-0528

Generic Name
Rufinamide
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dicyclomine Hydrochloride
NDC 0054-0622

Generic Name
Dicyclomine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Aminocaproic Acid
NDC 0054-1100

Generic Name
Aminocaproic Acid
Dosage Form
Syrup
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Lidocaine Viscous
NDC 0054-3500

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Oral; Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Propranolol Hydrochloride
NDC 0054-3727

Generic Name
Propranolol Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Propranolol Hydrochloride
NDC 0054-3730

Generic Name
Propranolol Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Gentamicin
NDC 0143-9128

Generic Name
Gentamicin
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Gentamicin
NDC 0143-9129

Generic Name
Gentamicin
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Haloperidol
NDC 0143-9319

Generic Name
Haloperidol Lactate
Dosage Form
Injection
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Labetalol Hydrochloride
NDC 0143-9320

Generic Name
Labetalol Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Succinylcholine Chloride
NDC 0143-9338

Generic Name
Succinylcholine Chloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Haloperidol
NDC 0143-9501

Generic Name
Haloperidol Lactate
Dosage Form
Injection
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Haloperidol
NDC 0143-9502

Generic Name
Haloperidol Lactate
Dosage Form
Injection
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Labetalol Hydrochloride
NDC 0143-9622

Generic Name
Labetalol Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Labetalol Hydrochloride
NDC 0143-9623

Generic Name
Labetalol Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Flumazenil
NDC 0143-9683

Generic Name
Flumazenil
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Flumazenil
NDC 0143-9684

Generic Name
Flumazenil
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Flumazenil
NDC 0143-9783

Generic Name
Flumazenil
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Flumazenil
NDC 0143-9784

Generic Name
Flumazenil
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-3177

Generic Name
Dexamethasone
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8174

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8175

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8176

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8179

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8180

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8181

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8183

Generic Name
Dexamethasone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Hemorrhoidal
NDC 0113-0188

Generic Name
Mineral Oil, Petrolatum, Phenylephrine Hcl
Dosage Form
Ointment
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Hemorrhoidal
NDC 0113-0279

Generic Name
Cocoa Butter, Phenylephrine Hcl
Dosage Form
Suppository
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Cough Dm
NDC 0113-0384

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Itch Relief
NDC 0113-0622

Generic Name
Diphenhydramine Hydrochloride, Zinc Acetate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Cough Dm
NDC 0113-0958

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Pain And Fever
NDC 0113-8959

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Noxafil
NDC 0085-2224

Generic Name
Posaconazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing

Merz Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Cuvposa
NDC 0259-0501

Generic Name
Glycopyrrolate
Dosage Form
Liquid
Route
Oral
Marketing
NDA
Active Listing

Mission Pharmacal Company

NDC Product
Human Otc Drug

Potassium Iodide
NDC 0178-0314

Generic Name
Potassium Iodide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Theragesic
NDC 0178-0320

Generic Name
Methyl Salicylate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Ovace Plus
NDC 0178-0485

Generic Name
Sulfacetamide Sodium
Dosage Form
Shampoo
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovace
NDC 0178-0499

Generic Name
Sulfacetamide Sodium
Dosage Form
Liquid
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovace Plus
NDC 0178-0630

Generic Name
Sodium Sulfacetamide
Dosage Form
Liquid
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Trileptal
NDC 0078-0357

Generic Name
Oxcarbazepine
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing

PAI Holdings, LLC

NDC Product
Human Otc Drug

Milk Of Magnesia
NDC 0121-0431

Generic Name
Magnesium Hydroxide
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mag-al Liquid
NDC 0121-1760

Generic Name
Aluminum Hydroxide And Magnesium Hydroxide
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Metoclopramide
NDC 0121-0576

Generic Name
Metoclopramide Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amantadine Hydrochloride
NDC 0121-0646

Generic Name
Amantadine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Trihexyphenidyl Hydrochloride
NDC 0121-0658

Generic Name
Trihexyphenidyl Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Calcium Carbonate
NDC 0121-0766

Generic Name
Calcium Carbonate
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-0799

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Sulfamethoxazole And Trimethoprim
NDC 0121-0853

Generic Name
Sulfamethoxazole And Trimethoprim
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sulfatrim
NDC 0121-0854

Generic Name
Sulfamethoxazole And Trimethoprim
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nystatin
NDC 0121-0868

Generic Name
Nystatin
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cetirizine Hydrochloride
NDC 0121-0874

Generic Name
Cetirizine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 0121-0904

Generic Name
Morphine Sulfate
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Docusate Sodium
NDC 0121-0935

Generic Name
Docusate Sodium
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Milk Of Magnesia Concentrate
NDC 0121-0940

Generic Name
Magnesium Hydroxide
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Lidocaine Hydrochloride
NDC 0121-0950

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Lidocaine Pain Relief
NDC 0121-0970

Generic Name
Lidocaine Pain Relief
Dosage Form
Patch
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Cimetidine Hydrochloride
NDC 0121-1025

Generic Name
Cimetidine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lithium
NDC 0121-1027

Generic Name
Lithium
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nystatin
NDC 0121-1045

Generic Name
Nystatin
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Promethazine Dm
NDC 0121-1070

Generic Name
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metoclopramide
NDC 0121-1576

Generic Name
Metoclopramide Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-1598

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Mag-al Plus
NDC 0121-1761

Generic Name
Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mag-al Plus Xs
NDC 0121-1762

Generic Name
Aluminum Hydroxide, Magnesium Hydroxide, And Dimethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Docusate Sodium
NDC 0121-1870

Generic Name
Docusate Sodium
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-2397

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lithium
NDC 0121-4027

Generic Name
Lithium
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Calcium Carbonate
NDC 0121-4766

Generic Name
Calcium Carbonate
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-4799

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine Hydrochloride
NDC 0121-4950

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Senna
NDC 0121-4967

Generic Name
Sennosides
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Par Health USA, LLC

NDC Product
Human Prescription Drug

Diazoxide
NDC 0254-1010

Generic Name
Diazoxide
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Lopid
NDC 0071-0737

Generic Name
Gemfibrozil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Pharmaceutical Associates, Inc.

NDC Product
Human Prescription Drug

Nystatin
NDC 0121-0810

Generic Name
Nystatin
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Propranolol Hydrochloride
NDC 0121-0908

Generic Name
Propranolol Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nystatin
NDC 0121-4810

Generic Name
Nystatin
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Depo-provera
NDC 0009-0746

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-subq Provera
NDC 0009-4709

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nicotrol
NDC 0009-5401

Generic Name
Nicotine
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-provera
NDC 0009-7376

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
NDA
Active Listing

Teva Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Diclofenac Epolamine
NDC 0093-3727

Generic Name
Diclofenac Epolamine
Dosage Form
System
Route
Topical
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Nortriptyline Hydrochloride
NDC 0093-0810

Generic Name
Nortriptyline Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nortriptyline Hydrochloride
NDC 0093-0811

Generic Name
Nortriptyline Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nortriptyline Hydrochloride
NDC 0093-0812

Generic Name
Nortriptyline Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nortriptyline Hydrochloride
NDC 0093-0813

Generic Name
Nortriptyline Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0093-2267

Generic Name
Amoxicillin
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0093-2268

Generic Name
Amoxicillin
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0093-3109

Generic Name
Amoxicillin
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Imiquimod
NDC 0093-3133

Generic Name
Imiquimod
Dosage Form
Cream
Route
Topical
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Methylergonovine Maleate
NDC 0093-3655

Generic Name
Methylergonovine Maleate
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0093-4155

Generic Name
Amoxicillin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing

Trividia Manufacturing Solutions, Inc

NDC Product
Human Otc Drug

Selan Plus Zinc Oxide
NDC 0159-2200

Generic Name
Selan Plus Zinc Oxide
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Selan Antifungal
NDC 0159-2500

Generic Name
Selan Antifungal
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Viatris Specialty LLC

NDC Product
Human Prescription Drug

Proctofoam Hc
NDC 0037-6822

Generic Name
Pramoxine Hydrochloride Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Proctofoam Ns
NDC 0037-6823

Generic Name
Pramoxine Hydrochloride
Dosage Form
Aerosol, Foam
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Epifoam
NDC 0037-6824

Generic Name
Pramoxine Hydrochloride And Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cortifoam
NDC 0037-6830

Generic Name
Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
NDA
Active Listing

WALGREEN COMPANY

NDC Product
Human Otc Drug

Walgreens Sunburn Relief
NDC 0363-0966

Generic Name
Menthol
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Advanced Regular Strength Antacid
NDC 0363-1639

Generic Name
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Maximum Strength Antacid Antigas
NDC 0363-1691

Generic Name
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Wal-zyr All Day Allergy
NDC 0363-2106

Generic Name
Cetirizine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Regular Strength Antacid Antigas
NDC 0363-2628

Generic Name
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

WALGREENS

NDC Product
Human Otc Drug

Infants Pain And Fever
NDC 0363-6555

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreen Co.

NDC Product
Human Otc Drug

Walgreens Sport Faces Spf 30
NDC 0363-3890

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Walgreens Cool N Heat Back Patch
NDC 0363-6657

Generic Name
Menthol
Dosage Form
Patch
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Cool N Heat Patch
NDC 0363-6670

Generic Name
Lidocaine, Menthol
Dosage Form
Patch
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreen Company

NDC Product
Human Otc Drug

Sodium Chloride
NDC 0363-0193

Generic Name
Sodium Chloride
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gentle Laxative
NDC 0363-0327

Generic Name
Bisacodyl
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cough Dm
NDC 0363-0384

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Cough Dm
NDC 0363-0494

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Walgreens
NDC 0363-0658

Generic Name
Sodium Chloride
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Cough Dm
NDC 0363-0899

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Walgreens Tolnaftate
NDC 0363-1298

Generic Name
Tolnaftate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Allergy Relief
NDC 0363-1900

Generic Name
Diphenhydramine Hcl
Dosage Form
Capsule
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hydrocortisone
NDC 0363-1973

Generic Name
Hydrocortisone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Original Strength Anti Itch
NDC 0363-4115

Generic Name
Diphenhydramine Hydrochloride, Zinc Acetate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Ivermectin
NDC 0363-4230

Generic Name
Ivermectin
Dosage Form
Lotion
Route
Topical
Marketing
ANDA
Active Listing

Walgreens

NDC Product
Human Otc Drug

Itch Relief Gel
NDC 0363-0353

Generic Name
Diphenhydramine Hcl
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreen Itch Relief Gel
NDC 0363-0354

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hydrocortisone
NDC 0363-0363

Generic Name
Cool Relief Gel With Aloe
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Hemorrhoidal
NDC 0363-0476

Generic Name
Hemorrhoidal Rectal Suppositories
Dosage Form
Suppository
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Hemorrhoidal
NDC 0363-0476

Generic Name
Hemorrhoidal Rectal Suppositories
Dosage Form
Suppository
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Hemorrhoidal
NDC 0363-0479

Generic Name
Hemorrhoidal Rectal Suppositories
Dosage Form
Suppository
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hemorrhoidal Cream
NDC 0363-0641

Generic Name
Hemorrhoidal Cream
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hemorrhoidal Cream
NDC 0363-0641

Generic Name
Hemorrhoidal Cream
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Intensive Healing Eczema
NDC 0363-0670

Generic Name
Hydrocortisone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Walgreens Zinc Spf 50
NDC 0363-4735

Generic Name
Octocrylene, Zinc Oxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Mucus Relief Cough Childrens
NDC 0363-5527

Generic Name
Dextromethorphan Hbr, Guaifensin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens
NDC 0363-6502

Generic Name
Hemorrhoidal Cooling Gel
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens
NDC 0363-6503

Generic Name
Hemorrhoidal Pain Relief
Dosage Form
Ointment
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreens Co.

NDC Product
Human Otc Drug

Hydrocortisone
NDC 0363-1333

Generic Name
Hydrocortisone
Dosage Form
Ointment
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreens Company

NDC Product
Human Otc Drug

Walgreens Anti Itch Cream
NDC 0363-2315

Generic Name
Anti Itch Cream
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

West-Ward Pharmaceuticals Corp

NDC Product
Human Prescription Drug

Ondansetron
NDC 0143-9890

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0143-9891

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing

Xttrium Laboratories, Inc

NDC Product
Human Prescription Drug

Amantadine
NDC 0116-4010

Generic Name
Amantadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Xttrium Laboratories, Inc.

NDC Product
Human Prescription Drug

Nystatin Oral Suspension
NDC 0116-4026

Generic Name
Nystatin
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine Hydrochloride
NDC 0116-4027

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Oral; Topical
Marketing
ANDA
Active Listing

External Clinical & Regulatory Resources

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