PROPYL GALLATE
UNII 8D4SNN7V92

Substance Identification & Data

This profile provides standardized clinical and technical data for Propyl Gallate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 8D4SNN7V92.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 121-79-9 and the RxNorm Concept ID (RxCUI) 1311134. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
8D4SNN7V92
CAS Registry Number
121-79-9
RxNorm Concept ID
1311134

Detailed Substance Profile

Preferred Name
PROPYL GALLATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
8D4SNN7V92
The specific atomic composition represented as a molecular structure string.
InChIKey
C10H12O5
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
ZTHYODDOHIVTJV-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C76728
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
4947
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
c1(c(cc(cc1O)C(=O)OCCC)O)O

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Propyl Gallate. 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

PROPYL GALLATE

Common Names & Synonyms

ANHYDROUS PROPYL GALLATE (E 310)
BENZOIC ACID, 3,4,5-TRIHYDROXY-, PROPYL ESTER
GALLIC ACID, PROPYL ESTER
N-PROPYL ESTER OF 3,4,5- TRIHYDROXYBENZOIC ACID
PROPYL GALLATE (E 310)
PROPYL GALLATE [EP MONOGRAPH]
PROPYL GALLATE [FCC]
PROPYL GALLATE [FHFI]
PROPYL GALLATE [HSDB]
PROPYL GALLATE [II]
PROPYL GALLATE [MART.]
PROPYL GALLATE [MI]
PROPYL GALLATE [USP-RS]
PROPYL GALLATE [VANDF]
PROPYL GALLATE [WHO-DD]

Systematic Nomenclature

PROPYL 3,4,5-TRIHYDROXYBENZOATE

Technical Codes

E-310
FEMA NO. 2947
INS NO.310
INS-310
NSC-2626

NDC Products Containing PROPYL GALLATE

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.
→ A-S Medication Solutions 8
→ Aurobindo Pharma Limited 1
→ BETTER LIVING BRANDS, LLC 1
→ CLINIQUE LABORATORIES LLC 2
→ CVS 2
→ CVS PHARMACY 10
→ CVS PHARMACY, INC 1
→ CVS PHARMACY, INC. 2
→ CVS Pharmacy, Inc. 1
→ DeMoulas Market Basket 2
→ Discount Drug Mart 1
→ Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1
→ EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 2
→ Endo USA, Inc. 3
→ FAMILY DOLLAR (Family Wellness) 1
→ FAMILY DOLLAR SERVICES INC 2
→ Fallien Cosmeceuticals, LTD 1
→ Genomma Lab USA, Inc 2
→ Genomma Lab USA, Inc. 1
→ Guardian Drug Company 6
→ H E B 3
→ Haleon US Holdings LLC 22
→ KROGER COMPANY 3
→ Kroger 1
→ Kroger Company 3
→ L. Perrigo Company 1
→ MEIJER DISTRIBUTION INC 1
→ MEIJER DISTRIBUTION INC. 1
→ MEIJER, INC. 2
→ Macleods Pharmaceuticals Limited 3
→ Major Pharmaceuticals 1
→ Meijer Distribution Inc 1
→ Menper Distributors, Inc. 2
→ Merck Sharp & Dohme LLC 3
→ NORTHSTAR RX LLC 4
→ Padagis Israel Pharmaceuticals Ltd 1
→ Perrigo Direct, Inc 1
→ Pharmadel LLC 3
→ Publix Super Markets Inc 1
→ RUGBY LABORATORIES 1
→ Rising Pharma Holdings, Inc. 3
→ Rite Aid Corporation 1
→ SAFEWAY 2
→ SUPERVALU INC 1
→ Safeway, Inc. 2
→ Sato Pharmaceutical Co., Ltd. 1
→ Softgel Healthcare Pvt Ltd 1
→ Sun Pharmaceutical Industries, Inc. 19
→ SuperValu Inc., 1
→ TARGET CORPORATION 4
→ TARGET Corporation 3
→ THE KROGER CO 1
→ THE KROGER CO. 1
→ Target Corporation 1
→ The Kroger Co. 2
→ Topco Associates LLC 1
→ Topiderm, Inc. 1
→ Torrent Pharmaceuticals Limited 3
→ Unichem Pharmaceuticals (USA), Inc. 2
→ United Natural Foods, Inc. dba UNFI 3
→ Validus Pharmaceuticals LLC 1
→ WALGREEN COMPANY 1
→ WALGREENS 1
→ WALGREENS CO 3
→ WALGREENS CO. 8
→ Wal-Mart Stores Inc 1
→ Wal-Mart Stores, Inc. 4
→ Wal-Mart Stores,Inc., 5
→ Walgreens 14
→ Walgreens Co 1

A-S Medication Solutions

NDC Product
Human Prescription Drug

Felodipine
NDC 50090-1124

Generic Name
Felodipine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ezetimibe And Simvastatin
NDC 50090-4772

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

Janumet Xr
NDC 50090-5504

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Felodipine
NDC 50090-5870

Generic Name
Felodipine
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ezetimibe And Simvastatin
NDC 50090-7047

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

Escitalopram Oxalate
NDC 50090-7200

Generic Name
Escitalopram Oxalate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Escitalopram Oxalate
NDC 50090-7201

Generic Name
Escitalopram Oxalate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 50090-7841

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Aurobindo Pharma Limited

NDC Product
Human Prescription Drug

Isotretinoin
NDC 59651-631

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

BETTER LIVING BRANDS, LLC

NDC Product
Human Otc Drug

Cold, Flu And Sore Throat Relief
NDC 21130-909

Generic Name
Acetaminophen 650 Mg, Dextromethorphan Hbr 20 Mg, Guaifenesi...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

CLINIQUE LABORATORIES LLC

CVS

NDC Product
Human Otc Drug

Childrens Cold And Cough
NDC 51316-578

Generic Name
Brompheniramine Maleate, Dextromethorphan, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Multi Symptom Cold Very Berry
NDC 51316-815

Generic Name
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

CVS PHARMACY

NDC Product
Human Otc Drug

Daytime Cold And Flu Relief
NDC 51316-617

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

Cvs Dt And Nt Combo Pack Cold And Flu
NDC 51316-618

Generic Name
Acetaminophen, Phenylephrine Hydrochloride, And Doxylamine S...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cvs Severe Multi-symptom Cough Cold Flu
NDC 51316-630

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, P...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cvs Nighttime Cold
NDC 51316-641

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Suc...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Dimetapp Cold And Cough
NDC 51316-645

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

Cvs Nighttime Cold And Flu Relief
NDC 51316-692

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cvs Daytime Cold And Flu Relief
NDC 51316-727

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

Cvs Childrens Nighttime Multi Symptom Cold
NDC 51316-733

Generic Name
Acetaminophen , Diphenhydramine Hydrochloride,phenylephrine ...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

CVS PHARMACY, INC

NDC Product
Human Otc Drug

Long Acting Cough Softgels
NDC 51316-778

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

CVS PHARMACY, INC.

CVS Pharmacy, Inc.

NDC Product
Human Otc Drug

Cvs Health Cough Suppressant Softgel
NDC 51316-877

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

DeMoulas Market Basket

NDC Product
Human Otc Drug

Cold And Sinus Maxium Strength
NDC 53942-515

Generic Name
Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cold, Flu And Sore Throat Maxium Strength
NDC 53942-516

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, P...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Discount Drug Mart

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Endo USA, Inc.

NDC Product
Human Prescription Drug

Felodipine
NDC 0603-3581

Generic Name
Felodipine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Felodipine
NDC 0603-3582

Generic Name
Felodipine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Felodipine
NDC 0603-3583

Generic Name
Felodipine
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

FAMILY DOLLAR (Family Wellness)

NDC Product
Human Otc Drug

Family Wellness Hemorrhoid
NDC 55319-981

Generic Name
Glycerin, Petrolatum, Phenylephrine Hcl, Pramoxine Hcl
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

FAMILY DOLLAR SERVICES INC

NDC Product
Human Otc Drug

Family Dollar Nighttime Cold And Flu Relief
NDC 55319-926

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine ...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Fallien Cosmeceuticals, LTD

Genomma Lab USA, Inc

NDC Product
Human Otc Drug

Tukol Max Action Cold, Sore Throat And Cough
NDC 50066-516

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Genomma Lab USA, Inc.

NDC Product
Human Otc Drug

Childrens Tukol Multi-symptom Cold And Flu
NDC 50066-519

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, P...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Guardian Drug Company

NDC Product
Human Otc Drug

Childrens Metapp Daytime
NDC 53041-577

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

Childrens Tussnex Multi-symptom Cold
NDC 53041-615

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

Tussnex Fm Cold And Sinus
NDC 53041-616

Generic Name
Acteaminophen, Guaifenesin, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tussnex Fm Severe Cough And Congestion
NDC 53041-617

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

Tussnex Fm Cold, Flu And Sore Throat
NDC 53041-618

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

Childrens Tussnex
NDC 53041-622

Generic Name
Acteaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

H E B

NDC Product
Human Otc Drug

Max Cold, Flu, And Sore Throat
NDC 37808-316

Generic Name
Acetaminophen,dextromethorphan Hydrobromide, Guaifenesin , P...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mucus Relief Cough Cold Sore Throat
NDC 37808-811

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Robitussin Long-acting Coughgels
NDC 0031-8743

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

Robitussin Direct Cough
NDC 0031-9302

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

Excedrin Extra Strength Geltabs
NDC 0067-2021

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

Excedrin Migraine Geltabs
NDC 0067-2035

Generic Name
Acetaminophen, Asprin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-0150

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-0151

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-0154

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-0160

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-0161

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-0165

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-0166

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil Multi-symptom Cold And Flu
NDC 0573-0190

Generic Name
Chlorpheniramine Maleate, Ibuprofen, Phenylephrine Hcl
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil Allergy And Congestion Relief
NDC 0573-0196

Generic Name
Chlorpheniramine Maleate, Ibuprofen, And Phenylephrine Hydro...
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil Sinus Congestion And Pain
NDC 0573-0199

Generic Name
Ibuprofen, Phenylephrine Hydrochloride
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Advil
NDC 0573-1711

Generic Name
Ibuprofen
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Preparation H Rapid Relief
NDC 0573-2843

Generic Name
Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochlo...
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Preparation H Maximum Strength
NDC 0573-2868

Generic Name
Glycerin, Petrolatum, Phenylephrine Hcl, Pramoxine Hcl
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Preparation H Rapid Relief
NDC 0573-2890

Generic Name
Lidocaine, Phenylephrine Hydrochloride
Dosage Form
Spray
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

KROGER COMPANY

NDC Product
Human Otc Drug

Maximum Strength Cold Flu And Sore Throat
NDC 30142-731

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Kroger Mucus Relief Dm Maximum Strength
NDC 41226-739

Generic Name
Dextromethorphan Hbr And Guaifenesin
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Kroger

NDC Product
Human Otc Drug

Childrens Multi-symptom Cold
NDC 41226-937

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hy...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Kroger Company

NDC Product
Human Otc Drug

Kroger Nighttime Cold And Flu Relief
NDC 30142-292

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Kroger Hemorrhoid
NDC 30142-713

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

Hemorrhoidal Maximum Strength Pain Relief
NDC 30142-944

Generic Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

L. Perrigo Company

MEIJER DISTRIBUTION INC

MEIJER DISTRIBUTION INC.

NDC Product
Human Otc Drug

Meijer Nighttime Cold And Flu
NDC 41250-869

Generic Name
Acetaminophen, Dextromethorphan Hbr, Triprolidine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

MEIJER, INC.

NDC Product
Human Otc Drug

Meijer Mucus Relief Dm Maximum Strength
NDC 41250-748

Generic Name
Dextromethorphan Hbr And Guaifenesin
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Macleods Pharmaceuticals Limited

NDC Product
Human Prescription Drug

Escitalopram Oxalate
NDC 33342-036

Generic Name
Escitalopram Oxalate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Escitalopram Oxalate
NDC 33342-037

Generic Name
Escitalopram Oxalate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Escitalopram Oxalate
NDC 33342-038

Generic Name
Escitalopram Oxalate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Major Pharmaceuticals

NDC Product
Human Prescription Drug

Posaconazole
NDC 0904-7149

Generic Name
Posaconazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Meijer Distribution Inc

NDC Product
Human Otc Drug

Hemorrhoidal
NDC 41250-944

Generic Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Menper Distributors, Inc.

NDC Product
Human Otc Drug

Mucosan Max With Acetaminophen
NDC 53145-696

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin An...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mucosan Severe Multi-symptom
NDC 53145-697

Generic Name
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Janumet Xr
NDC 0006-0078

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Janumet Xr
NDC 0006-0080

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Janumet Xr
NDC 0006-0081

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing

NORTHSTAR RX LLC

NDC Product
Human Prescription Drug

Ezetimibe And Simvastatin
NDC 16714-778

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

Ezetimibe And Simvastatin
NDC 16714-779

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

Ezetimibe And Simvastatin
NDC 16714-780

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

Ezetimibe And Simvastatin
NDC 16714-781

Generic Name
Ezetimibe And Simvastatin
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Padagis Israel Pharmaceuticals Ltd

NDC Product
Human Prescription Drug

Fluocinonide
NDC 45802-761

Generic Name
Fluocinonide
Dosage Form
Gel
Route
Topical
Marketing
ANDA
Active Listing

Perrigo Direct, Inc

NDC Product
Human Otc Drug

Goodsense Hemorrhoidal Pain Relief
NDC 50804-317

Generic Name
Glycerin, Lidocaine, Petrolatum, Phenylephrine Hcl
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Pharmadel LLC

NDC Product
Human Otc Drug

Sanatos X
NDC 55758-311

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

Sanatos Turbo Max Strength
NDC 55758-322

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

Sanatos X Children
NDC 55758-443

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Publix Super Markets Inc

NDC Product
Human Otc Drug

Hemorrhoidal
NDC 56062-944

Generic Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

RUGBY LABORATORIES

NDC Product
Human Otc Drug

Dextromethorphan Hbr 15 Mg Liquid Gels
NDC 0536-1334

Generic Name
Dextromethorphan Hbr
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Rising Pharma Holdings, Inc.

NDC Product
Human Prescription Drug

Felodipine
NDC 57237-108

Generic Name
Felodipine
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Felodipine
NDC 57237-109

Generic Name
Felodipine
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Felodipine
NDC 57237-110

Generic Name
Felodipine
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Rite Aid Corporation

NDC Product
Human Otc Drug

Hemorrhoidal
NDC 11822-2944

Generic Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

SAFEWAY

NDC Product
Human Otc Drug

Signature Care Childrens Multi Symptom Cold
NDC 21130-162

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrin...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

SUPERVALU INC

Safeway, Inc.

NDC Product
Human Otc Drug

Mucus Relief Dm Maximum Strength
NDC 21130-505

Generic Name
Dextromethorphan Hbr, Guaifenesin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Sato Pharmaceutical Co., Ltd.

NDC Product
Human Otc Drug

Hi Vetic
NDC 49873-050

Generic Name
Tolnaftate
Dosage Form
Solution
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Softgel Healthcare Pvt Ltd

NDC Product
Human Otc Drug

Dextromethorphan Hydrobromide
NDC 35916-0461

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Sun Pharmaceutical Industries, Inc.

NDC Product
Human Prescription Drug

Absorica Ld
NDC 10631-002

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica Ld
NDC 10631-003

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica Ld
NDC 10631-005

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica Ld
NDC 10631-007

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica
NDC 10631-115

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica
NDC 10631-116

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica
NDC 10631-117

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica
NDC 10631-118

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica
NDC 10631-133

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Absorica
NDC 10631-134

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Fluocinonide
NDC 51672-1264

Generic Name
Fluocinonide
Dosage Form
Ointment
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fluocinonide
NDC 51672-1279

Generic Name
Fluocinonide
Dosage Form
Gel
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amcinonide
NDC 51672-4060

Generic Name
Amcinonide
Dosage Form
Ointment
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Isotretinoin
NDC 57664-020

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Isotretinoin
NDC 57664-021

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Isotretinoin
NDC 57664-022

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Isotretinoin
NDC 57664-023

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Isotretinoin
NDC 57664-024

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Isotretinoin
NDC 57664-025

Generic Name
Isotretinoin
Dosage Form
Capsule
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

SuperValu Inc.,

TARGET CORPORATION

NDC Product
Human Otc Drug

Target Overnight Cold And Flu
NDC 11673-698

Generic Name
Acetaminophen, Dextromethorphan Hbr, Triprolidine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

TARGET Corporation

THE KROGER CO

NDC Product
Human Otc Drug

Maximum Strength Nighttime Cold And Flu
NDC 30142-736

Generic Name
Acetaminophen , Diphenhydramine Hcl,phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

THE KROGER CO.

NDC Product
Human Otc Drug

Childrens Multi Symptom Fever And Cold
NDC 30142-988

Generic Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hb...
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Target Corporation

The Kroger Co.

NDC Product
Human Otc Drug

Mucus Relief Dm
NDC 30142-508

Generic Name
Dextromethorphan Hydrobromide Guaifenesin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Daytime Cold And Flu Relief
NDC 30142-722

Generic Name
Acetaminohpen, Dextromethorphan Hbr, Guaifenesin Phenylephri...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Topco Associates LLC

NDC Product
Human Otc Drug

Topcare Hemorrhoidal
NDC 36800-944

Generic Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Topiderm, Inc.

NDC Product
Human Otc Drug

Antioxidant Sunscreen Spf 40
NDC 51326-829

Generic Name
Octinoxate And Zinc Oxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Torrent Pharmaceuticals Limited

NDC Product
Human Prescription Drug

Felodipine
NDC 13668-132

Generic Name
Felodipine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Felodipine
NDC 13668-133

Generic Name
Felodipine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Felodipine
NDC 13668-134

Generic Name
Felodipine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Unichem Pharmaceuticals (USA), Inc.

NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 29300-380

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 29300-381

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

United Natural Foods, Inc. dba UNFI

NDC Product
Human Otc Drug

Equaline Hemorrhoidal
NDC 41163-944

Generic Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Validus Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Raldesy Tm
NDC 30698-455

Generic Name
Trazodone Hydrochloride Oral
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

WALGREEN COMPANY

WALGREENS

NDC Product
Human Otc Drug

Walgreen Severe Multi-symptom Cough Cold Flu
NDC 0363-6300

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, P...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

WALGREENS CO

NDC Product
Human Otc Drug

Overnight Cold And Flu
NDC 0363-6980

Generic Name
Acetaminophen, Dextromethorphan Hbr, Triprolidine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mucus Relief Dm Maximum Strength
NDC 0363-7390

Generic Name
Dextromethorphan Hbr And Guaifenesin
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

WALGREENS CO.

NDC Product
Human Otc Drug

Walgreen Nighttime Cold And Flu Relief
NDC 0363-6142

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, A...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Wag Hbp Daytime And Nighttime Cold And Flu
NDC 0363-6220

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreen Daytimel Kids Cold Cough Plus Mucus
NDC 0363-6238

Generic Name
Guaifenesin, Phenylephrine Hydrochloride And Dextromethorpha...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Daytime Cold And Flu Relief
NDC 0363-7270

Generic Name
Acetaminohpen, Dextromethorphan Hbr, Guaifenesin Phenylephri...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Wal-Mart Stores Inc

NDC Product
Human Otc Drug

Equate Hemorrhoidal
NDC 49035-944

Generic Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Wal-Mart Stores, Inc.

NDC Product
Human Otc Drug

Childrens Multi-symptom Cold
NDC 49035-715

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

Childrens Multi-symptom Cold And Fever Liquid
NDC 49035-772

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH FINAL
Active Listing

Wal-Mart Stores,Inc.,

NDC Product
Human Otc Drug

Maximum Strength Mucus Relief Dm
NDC 49035-839

Generic Name
Dextromethorphan Hydrobromide And Guaifenesin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreens

NDC Product
Human Otc Drug

Nighttime Cold And Flu Maximum Strength
NDC 0363-0460

Generic Name
Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mucus Relief All In One Maximum Strength
NDC 0363-0886

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

Walgreens Hemorrhoidal Pain Relief
NDC 0363-1217

Generic Name
Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine ...
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cough Cold And Sore Throat Childrens
NDC 0363-4050

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

Mucus Relief All In One Maximum Strength
NDC 0363-9130

Generic Name
Acetaminophen, Diphenhydramine Hcl Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreens Co

NDC Product
Human Otc Drug

Walgreens Pain Relief With Lidocaine
NDC 0363-1026

Generic Name
Lidocaine, Phenylephrine Hcl
Dosage Form
Spray
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

External Clinical & Regulatory Resources

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