BENZYL ALCOHOL
UNII LKG8494WBH

Substance Identification & Data

This profile provides standardized clinical and technical data for Benzyl Alcohol, uniquely identified by the FDA Unique Ingredient Identifier (UNII) LKG8494WBH.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 100-51-6 and the RxNorm Concept ID (RxCUI) 1426. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
LKG8494WBH
CAS Registry Number
100-51-6
RxNorm Concept ID
1426

Detailed Substance Profile

Preferred Name
BENZYL ALCOHOL
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
LKG8494WBH
The specific atomic composition represented as a molecular structure string.
InChIKey
C7H8O
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
WVDDGKGOMKODPV-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C77028
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
244
Unique identification number in the NCBI database of chemical substances.
INN ID
923
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
c1ccc(cc1)CO

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Benzyl Alcohol. 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

BENZYL ALCOHOL

Common Names & Synonyms

ALCOHOL BENZYLICUS [WHO-IP LATIN]
ALCOHOL, BENZYL
ALCOHOL,BENZYL [VANDF]
BENZALKONIUM CHLORIDE IMPURITY A [EP IMPURITY]
BENZALKONIUM CHLORIDE SOLUTION IMPURITY A [EP IMPURITY]
BENZYL ALCOHOL [EP MONOGRAPH]
BENZYL ALCOHOL [FCC]
BENZYL ALCOHOL [FHFI]
BENZYL ALCOHOL [HSDB]
BENZYL ALCOHOL [II]
BENZYL ALCOHOL [INN]
BENZYL ALCOHOL [JAN]
BENZYL ALCOHOL [MART.]
BENZYL ALCOHOL [MI]
BENZYL ALCOHOL [ORANGE BOOK]
BENZYL ALCOHOL [USP-RS]
BENZYL ALCOHOL [VANDF]
BENZYL ALCOHOL [WHO-DD]
BENZYL ALCOHOL [WHO-IP]

Brand / Trade Names

ULESFIA

Systematic Nomenclature

(HYDROXYMETHYL)BENZENE
.ALPHA.-HYDROXYTOLUENE
BENZENEMETHANOL
PHENYLCARBINOL

Technical Codes

E-1519
FEMA NO. 2137
INS NO.1519
INS-1519
NSC-8044

NDC Products Containing BENZYL ALCOHOL

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.
→ Amneal Pharmaceuticals of New York LLC 1
→ AstraZeneca Pharmaceuticals LP 1
→ BF ASCHER AND CO INC 1
→ Bausch Health US LLC 5
→ Bausch Health US, LLC 1
→ Baxter Healthcare Company 1
→ Baxter Healthcare Corporation 1
→ Crown Laboratories 2
→ Crown Laboratories, Inc 1
→ Crown Laboratories, Inc. 1
→ E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 1
→ E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 7
→ E.R. Squibb & Sons, L.L.C. 2
→ Fougera Pharmaceuticals Inc. 1
→ Fougera Pharmaceuticals, LLC 2
→ Galderma Laboratories, L.P. 8
→ GlaxoSmithKline LLC 2
→ Haleon US Holdings LLC 8
→ Hikma Pharmaceuticals USA Inc. 35
→ L. Perrigo Company 6
→ Mission Pharmacal Company 8
→ PAI Holdings, LLC dba PAI Pharma 7
→ Person and Covey 10
→ Pfizer Laboratories Div Pfizer Inc 5
→ Pharmacia & Upjohn Company LLC 20
→ Sanofi-Aventis U.S. LLC 6
→ Teva Pharmaceuticals USA, Inc. 5
→ WALGREEN COMPANY 13
→ Walgreen 1
→ Walgreen Co. 3
→ Walgreen Company 13
→ Walgreens 12
→ Walgreens Co 1
→ Walgreens Company 6
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1
→ sanofi-aventis U.S. LLC 2

Amneal Pharmaceuticals of New York LLC

NDC Product
Human Prescription Drug

Diclofenac Sodium
NDC 0115-1483

Generic Name
Diclofenac Sodium
Dosage Form
Gel
Route
Topical
Marketing
ANDA
Active Listing

AstraZeneca Pharmaceuticals LP

NDC Product
Human Prescription Drug

Faslodex
NDC 0310-0720

Generic Name
Fulvestrant
Dosage Form
Injection
Route
Intramuscular
Marketing
NDA
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

Retin-a Micro
NDC 0187-5140

Generic Name
Tretinoin
Dosage Form
Gel
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Retin-a Micro
NDC 0187-5144

Generic Name
Tretinoin
Dosage Form
Gel
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Retin-a Micro
NDC 0187-5146

Generic Name
Tretinoin
Dosage Form
Gel
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Retin-a Micro
NDC 0187-5148

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

Altreno
NDC 0187-0005

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

Baxter Healthcare Company

NDC Product
Human Prescription Drug

Mesnex
NDC 0338-1307

Generic Name
Mesna
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing

Baxter Healthcare Corporation

NDC Product
Human Prescription Drug

Mesnex
NDC 0338-1305

Generic Name
Mesna
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing

Crown Laboratories

NDC Product
Human Otc Drug

Sarna
NDC 0316-0230

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

Crown Laboratories, Inc

NDC Product
Human Otc Drug

Sarna
NDC 0316-0234

Generic Name
Pramoxine Hydrochloride, Menthol
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Crown Laboratories, Inc.

NDC Product
Human Otc Drug

Panoxyl Acne Banishing Body (spray)
NDC 0316-0297

Generic Name
Salicylic Acid
Dosage Form
Aerosol, Spray
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Clotrimazole
NDC 0168-0133

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

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

NDC Product
Human Prescription Drug

Triamcinolone Acetonide
NDC 0168-0002

Generic Name
Triamcinolone Acetonide
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Triamcinolone Acetonide
NDC 0168-0003

Generic Name
Triamcinolone Acetonide
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Triamcinolone Acetonide
NDC 0168-0004

Generic Name
Triamcinolone Acetonide
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Hydrocortisone
NDC 0168-0015

Generic Name
Hydrocortisone
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Hydrocortisone
NDC 0168-0080

Generic Name
Hydrocortisone
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clindamycin Phosphate
NDC 0168-0277

Generic Name
Clindamycin Phosphate
Dosage Form
Cream
Route
Vaginal
Marketing
ANDA
Active Listing

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

NDC Product
Human Prescription Drug

Kenalog-40
NDC 0003-0293

Generic Name
Triamcinolone Acetonide
Dosage Form
Injection, Suspension
Route
Intra-articular; Intramuscular
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Kenalog-10
NDC 0003-0494

Generic Name
Triamcinolone Acetonide
Dosage Form
Injection, Suspension
Route
Intra-articular; Intralesional
Marketing
NDA
Active Listing

Fougera Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Amcinonide
NDC 0168-0278

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

Fougera Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Metronidazole
NDC 0168-0323

Generic Name
Metronidazole
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metronidazole
NDC 0168-0383

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

Galderma Laboratories, L.P.

NDC Product
Human Prescription Drug

Metrocream
NDC 0299-3836

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

Cetaphil
NDC 0299-3928

Generic Name
Octocrylene, Avobenzone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cetaphil Acne Relief Body Wash
NDC 0299-4121

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

Differin Acne Clearing Body Wash
NDC 0299-4131

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

Cetaphil Sun Tinted Face Spf 40
NDC 0299-4145

Generic Name
Titanium Dioxide, Zinc Oxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

GlaxoSmithKline LLC

NDC Product
Human Prescription Drug

Mepron
NDC 0173-0547

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

Mepron
NDC 0173-0665

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

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Gaviscon
NDC 0135-0094

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

Gaviscon
NDC 0135-0095

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

Abreva
NDC 0135-0200

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

Abreva
NDC 0135-0300

Generic Name
Docosanol
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Gaviscon
NDC 0135-0574

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

Flonase Headache And Allergy Relief
NDC 0135-0578

Generic Name
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Testosterone Cypionate
NDC 0143-9005

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

Fulvestrant
NDC 0143-9022

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

Mesna
NDC 0143-9260

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

Estradiol Valerate
NDC 0143-9290

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

Estradiol Valerate
NDC 0143-9291

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

Haloperidol Decanoate
NDC 0143-9295

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

Haloperidol Decanoate
NDC 0143-9296

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

Etoposide
NDC 0143-9376

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

Triamcinolone Acetonide
NDC 0143-9387

Generic Name
Triamcinolone Acetonide
Dosage Form
Injection, Suspension
Route
Intra-articular; Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cisatracurium Besylate
NDC 0143-9397

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

Etoposide
NDC 0143-9510

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

Etoposide
NDC 0143-9511

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

Etoposide
NDC 0143-9512

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

Fluphenazine Decanoate
NDC 0143-9529

Generic Name
Fluphenazine Decanoate
Dosage Form
Injection
Route
Intramuscular; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Glycopyrrolate
NDC 0143-9584

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

Glycopyrrolate
NDC 0143-9585

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

Glycopyrrolate
NDC 0143-9586

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

Glycopyrrolate
NDC 0143-9587

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

Cyanocobalamin
NDC 0143-9619

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

Cyanocobalamin
NDC 0143-9620

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

Cyanocobalamin
NDC 0143-9621

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

Testosterone Cypionate
NDC 0143-9659

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

Glycopyrrolate
NDC 0143-9679

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

Glycopyrrolate
NDC 0143-9680

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

Glycopyrrolate
NDC 0143-9681

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

Glycopyrrolate
NDC 0143-9682

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

Progesterone
NDC 0143-9725

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

Testosterone Cypionate
NDC 0143-9726

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

Granisetron Hydrochloride
NDC 0143-9744

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

Granisetron Hydrochloride
NDC 0143-9745

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

Enalaprilat
NDC 0143-9786

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

Enalaprilat
NDC 0143-9787

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

Amiodarone Hydrochloride
NDC 0143-9875

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

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Nasal
NDC 0113-0304

Generic Name
Oxymetazoline Hydrochloride
Dosage Form
Spray
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nasal
NDC 0113-0388

Generic Name
Oxymetazoline Hcl
Dosage Form
Spray, Metered
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nasal Four
NDC 0113-0648

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Spray
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Omeprazole
NDC 0113-1723

Generic Name
Omeprazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Tussin
NDC 0113-2009

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

Good Sense Nasal
NDC 0113-6200

Generic Name
Oxymetazoline Hydrochloride
Dosage Form
Spray
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing

Mission Pharmacal Company

NDC Product
Human Prescription Drug

Avar-e Green
NDC 0178-0460

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

Avar-e Ls
NDC 0178-0465

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

Avar-e
NDC 0178-0470

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

Avar Ls
NDC 0178-0475

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

Avar
NDC 0178-0480

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

Ovace Plus
NDC 0178-0490

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

Ovaceplus Plus
NDC 0178-0495

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

Ovace Plus
NDC 0178-0620

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

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Phenobarbital Oral Solution
NDC 0121-0942

Generic Name
Phenobarbital Oral
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Atovaquone
NDC 0121-0956

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

Atovaquone
NDC 0121-1016

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

Lincomycin
NDC 0121-1035

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

Phenobarbital Oral Solution
NDC 0121-1884

Generic Name
Phenobarbital Oral
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Leuprolide Acetate
NDC 0121-2106

Generic Name
Leuprolide Acetate
Dosage Form
Kit
Route
Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenobarbital Oral Solution
NDC 0121-2826

Generic Name
Phenobarbital Oral
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Person and Covey

NDC Product
Human Otc Drug

Solbar Shield Spf40
NDC 0096-0682

Generic Name
Solbar Shield Spf40
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Solbar Avo Spf35
NDC 0096-0687

Generic Name
Solbar Avo Spf35
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Solbar Zinc Spf38
NDC 0096-0688

Generic Name
Solbar Zinc Spf38
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Solbar Sunscreen 35 Avo
NDC 0096-0690

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

Solbar Sunscreen 40 Zinc
NDC 0096-0691

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

Solbar Sunscreen 40 Shield
NDC 0096-0692

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

Solbar Sunscreen 50 Fifty
NDC 0096-0693

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

Aquanil Hc
NDC 0096-0732

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

Solbar Fifty Spf50
NDC 0096-0741

Generic Name
Solbar Fifty Spf50
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Aquanil Hc
NDC 0096-0810

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Heparin Sodium
NDC 0069-0043

Generic Name
Heparin Sodium
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Fragmin
NDC 0069-0232

Generic Name
Dalteparin Sodium
Dosage Form
Injection
Route
Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Trazimera
NDC 0069-0305

Generic Name
Trastuzumab-qyyp
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Retacrit
NDC 0069-1311

Generic Name
Epoetin Alfa-epbx
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Retacrit
NDC 0069-1318

Generic Name
Epoetin Alfa-epbx
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0003

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0018

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0039

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0039

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0047

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0047

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-testosterone
NDC 0009-0085

Generic Name
Testosterone Cypionate
Dosage Form
Injection, Solution
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Depo-testosterone
NDC 0009-0086

Generic Name
Testosterone Cypionate
Dosage Form
Injection, Solution
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0274

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0280

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0306

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-testosterone
NDC 0009-0347

Generic Name
Testosterone Cypionate
Dosage Form
Injection, Solution
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Depo-testosterone
NDC 0009-0417

Generic Name
Testosterone Cypionate
Dosage Form
Injection, Solution
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0850

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Hemabate
NDC 0009-0856

Generic Name
Carboprost Tromethamine
Dosage Form
Injection, Solution
Route
Intramuscular
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Cleocin
NDC 0009-3448

Generic Name
Clindamycin Phosphate
Dosage Form
Cream
Route
Vaginal
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Caverject
NDC 0009-3701

Generic Name
Alprostadil
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intracavernous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Caverject Impulse
NDC 0009-5181

Generic Name
Alprostadil
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intracavernous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Caverject Impulse
NDC 0009-5182

Generic Name
Alprostadil
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intracavernous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Caverject
NDC 0009-7686

Generic Name
Alprostadil
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intracavernous
Marketing
NDA
Active Listing

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Lovenox
NDC 0075-0626

Generic Name
Enoxaparin Sodium
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lovenox
NDC 0075-2912

Generic Name
Enoxaparin Sodium
Dosage Form
Injection
Route
Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lovenox
NDC 0075-2915

Generic Name
Enoxaparin Sodium
Dosage Form
Injection
Route
Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lovenox
NDC 0075-8022

Generic Name
Enoxaparin Sodium
Dosage Form
Injection
Route
Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lovenox
NDC 0075-8025

Generic Name
Enoxaparin Sodium
Dosage Form
Injection
Route
Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lovenox
NDC 0075-8030

Generic Name
Enoxaparin Sodium
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing

Teva Pharmaceuticals USA, Inc.

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

Cephalexin
NDC 0093-4175

Generic Name
Cephalexin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cephalexin
NDC 0093-4177

Generic Name
Cephalexin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Oseltamivir Phosphate
NDC 0093-8180

Generic Name
Oseltamivir Phosphate
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Doxepin Hydrochloride
NDC 0093-9609

Generic Name
Doxepin Hydrochloride
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing

WALGREEN COMPANY

NDC Product
Human Otc Drug

Walgreens Spf 50 Hydrating
NDC 0363-0136

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Spf 30 Hydrating
NDC 0363-0146

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens 3 Step Acne System
NDC 0363-0153

Generic Name
Benzoyl Peroxide
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens 70 Sheer Sunscreen
NDC 0363-0261

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Sunburn Relief
NDC 0363-0978

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

Walgreens Sunburn Relief
NDC 0363-0985

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

Walgreens 70 Sport Sunscreen
NDC 0363-1362

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Lotion
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

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
NDC Product
Human Otc Drug

Terbinafine Hydrochloride
NDC 0363-4502

Generic Name
Terbinafine Hydrochloride
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing

Walgreen

NDC Product
Human Otc Drug

Acne Control
NDC 0363-5834

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

Walgreen Co.

NDC Product
Human Otc Drug

Daily Moisturizing
NDC 0363-0619

Generic Name
Daily Moistruizing
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Baby Eczema Therapy
NDC 0363-0986

Generic Name
Colloidal Oatmeal
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
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

Walgreen Company

NDC Product
Human Otc Drug

Omeprazole
NDC 0363-0007

Generic Name
Omeprazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Anefrin Nasal Original
NDC 0363-0304

Generic Name
Oxymetazoline Hydrochloride
Dosage Form
Spray
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Nasal
NDC 0363-0717

Generic Name
Phenylephrine Hydrochloride
Dosage Form
Spray
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Clotrimazole 3
NDC 0363-2062

Generic Name
Clotrimazole
Dosage Form
Cream
Route
Vaginal
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Walgreens Athletes Foot
NDC 0363-2080

Generic Name
Terbinafine Hydrochloride
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Athletes Foot
NDC 0363-2100

Generic Name
Butenafine Hydrochloride
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Jock Itch
NDC 0363-2101

Generic Name
Butenafine Hydrochloride
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Clotrimazole
NDC 0363-2105

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

Ringworm
NDC 0363-2107

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

Walgreens Jock Itch
NDC 0363-2109

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

Walgreens

NDC Product
Human Otc Drug

Clotrimazole
NDC 0363-0220

Generic Name
Clotrimazole
Dosage Form
Cream
Route
Vaginal
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Walgreen Anti-itch
NDC 0363-0263

Generic Name
Pramoxine Hcl
Dosage Form
Lotion
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 Cool N Heat
NDC 0363-3036

Generic Name
Lidocaine 4%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Pain Relieving Cream
NDC 0363-3037

Generic Name
Lidocaine 4%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Mouth Sore Relief
NDC 0363-5334

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

Walgreens Maximum Strength
NDC 0363-5820

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

Walgreens Co

NDC Product
Human Otc Drug

Lidocaine Hemorrhoid
NDC 0363-1657

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

Walgreens Company

NDC Product
Human Otc Drug

Severe Sinus Relief Mist
NDC 0363-2305

Generic Name
Oxymetazoline Spray
Dosage Form
Liquid
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

No Drip Nasal Mist
NDC 0363-2307

Generic Name
Oxymetazoline Spray
Dosage Form
Liquid
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

No Drip Severe Anefrin Nasal
NDC 0363-2350

Generic Name
0.05% Oxymetazoline Hcl
Dosage Form
Spray
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Walgreens Pain Relief
NDC 0363-5061

Generic Name
Benzocaine
Dosage Form
Gel
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Premarin Vaginal
NDC 0046-0872

Generic Name
Conjugated Estrogens
Dosage Form
Cream
Route
Vaginal
Marketing
NDA
Active Listing

sanofi-aventis U.S. LLC

NDC Product
Human Prescription Drug

Ferrlecit
NDC 0024-2792

Generic Name
Sodium Ferric Gluconate Complex
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Ferrlecit
NDC 0024-2794

Generic Name
Sodium Ferric Gluconate Complex
Dosage Form
Injection
Route
Intravenous
Marketing
NDA
Active Listing

External Clinical & Regulatory Resources

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