GLYCERYL MONOSTEARATE
UNII 230OU9XXE4

Substance Identification & Data

This profile provides standardized clinical and technical data for Glyceryl Monostearate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 230OU9XXE4.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 91052-47-0 and the RxNorm Concept ID (RxCUI) 1311165. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
230OU9XXE4
CAS Registry Number
91052-47-0
RxNorm Concept ID
1311165

Detailed Substance Profile

Preferred Name
GLYCERYL MONOSTEARATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
230OU9XXE4
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C80900
National Cancer Institute reference terminology for clinical and research data.
Substance Type
mixture
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Glyceryl Monostearate. 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

GLYCERYL STEARATE

Common Names & Synonyms

CERASYNT-SD
CERASYNT-SD [VANDF]
CITHROL GMS 0400
GLYCERIDES, C16-18 MONO-
GLYCEROL MONOSTEARATE
GLYCEROL STEARATE
GLYCEROLI MONOSTEARAS [WHO-IP LATIN]
GLYCERYL MONOPALMITOSTEARATE
GLYCERYL MONOSTEARATE
GLYCERYL MONOSTEARATE [FCC]
GLYCERYL MONOSTEARATE [FHFI]
GLYCERYL MONOSTEARATE [II]
GLYCERYL MONOSTEARATE [JAN]
GLYCERYL MONOSTEARATE [MI]
GLYCERYL MONOSTEARATE [VANDF]
GLYCERYL MONOSTEARATE [WHO-DD]
GLYCERYL MONOSTEARATE [WHO-IP]
GLYCERYL STEARATE [II]
GLYCERYL STEARATE [VANDF]
MONOGLYCERIDES, C16-18
MONOSTEARIN
OCTADECANOIC ACID, MONOESTER WITH 1,2,3-PROPANETRIOL
STEARIC ACID, MONOESTER WITH GLYCEROL
STEARIN
STEARIN, MONO-

Brand / Trade Names

CERASYNT SD
CREMOPHOR GMSK
CUTINA GMS
IMWITOR 491
LONZEST GMS
NIKKOL MGS-A
SORBON MG-100

Technical Codes

FEMA NO. 2527

NDC Products Containing GLYCERYL MONOSTEARATE

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.
→ 7-Eleven 1
→ Access Business Group LLC 1
→ Acme United Corporation 2
→ Actavis Pharma, Inc. 1
→ Alchemee, LLC 7
→ AstraZeneca Pharmaceuticals LP 7
→ BF ASCHER AND CO INC 1
→ Bausch Health US, LLC 1
→ Beiersdorf Inc 8
→ Combe Incorporated 3
→ Cosette Pharmaceuticals, Inc. 4
→ Crown Laboratories 1
→ Crown Laboratories, Inc 1
→ Crown Laboratories, Inc. 1
→ E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 3
→ E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 5
→ Fougera Pharmaceuticals, LLC 1
→ Galderma Laboratories, L.P. 11
→ Genuine Virgin Aloe Corporation 4
→ GlaxoSmithKline LLC 9
→ Haleon US Holdings LLC 4
→ Henry Schein 1
→ Henry Schein, Inc. 1
→ Humco Holding Group, Inc. 1
→ Kao USA Inc. 4
→ L Perrigo Company 1
→ L. Perrigo Company 9
→ Major Pharmaceuticals 1
→ Marlex Pharmaceuticals, Inc. 1
→ Mission Pharmacal Company 6
→ Mylan Pharmaceuticals Inc. 7
→ Nature's Innovation, Inc 1
→ Nature's Innovation, Inc. 5
→ Nice-Pak Products, LLC 2
→ Padagis US LLC 5
→ Person and Covey 3
→ Pfizer Laboratories Div Pfizer Inc 1
→ Port Jervis Laboratories, Inc 2
→ REVLON 4
→ Revlon 1
→ Revlon Consumer Products Corp 2
→ Rugby Laboratories 6
→ SMASHBOX BEAUTY COSMETICS, INC 1
→ Sandoz Inc 2
→ Sun Pharmaceutical Industries, Inc. 1
→ Teva Pharmaceuticals USA, Inc. 3
→ The Mentholatum Company 4
→ Trividia Manufacturing Solutions, Inc 1
→ Vi-Jon, LLC 1
→ Viatris Specialty LLC 3
→ WALGREEN CO. 2
→ WALGREEN COMPANY 10
→ WALGREENS 2
→ WALGREENS COMPANY 1
→ Walgreen Co. 3
→ Walgreen Company 15
→ Walgreens 4
→ Walgreens Co 1
→ Walgreens Co. 1
→ Walgreens Company 3
→ Weeks & Leo Compnay, INC. 1
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1

7-Eleven

NDC Product
Human Otc Drug

Acid Reducer
NDC 10202-722

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

Access Business Group LLC

Acme United Corporation

NDC Product
Human Otc Drug

First Aid Only First Aid/burn
NDC 0924-5011

Generic Name
Lidocaine Hydrochloride And Benzalkonium Chloride
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

First Aid Only First Aid/burn
NDC 0924-5730

Generic Name
Lidocaine Hydrochloride, Benzalkonium Chloride
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Actavis Pharma, Inc.

NDC Product
Human Prescription Drug

Clarithromycin
NDC 0591-2805

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

Alchemee, LLC

NDC Product
Human Otc Drug

Proactiv Renewing Cleanser
NDC 11410-005

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

Proactiv Clarifying Night
NDC 11410-030

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

Proactiv Repairing Treatment
NDC 11410-040

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

Proactiv Solution Kit
NDC 11410-215

Generic Name
Solutions Kit
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing

AstraZeneca Pharmaceuticals LP

NDC Product
Human Prescription Drug

Nexium
NDC 0186-4010

Generic Name
Esomeprazole Magnesium
Dosage Form
Granule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nexium
NDC 0186-4020

Generic Name
Esomeprazole Magnesium
Dosage Form
Granule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nexium
NDC 0186-4025

Generic Name
Esomeprazole Magnesium
Dosage Form
Granule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nexium
NDC 0186-4040

Generic Name
Esomeprazole Magnesium
Dosage Form
Granule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nexium
NDC 0186-4050

Generic Name
Esomeprazole Magnesium
Dosage Form
Granule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nexium
NDC 0186-5020

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nexium
NDC 0186-5040

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing

BF ASCHER AND CO INC

NDC Product
Human Otc Drug

Mobisyl
NDC 0225-0360

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

Bausch Health US, LLC

NDC Product
Human Prescription Drug

Noritate
NDC 0187-5202

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

Beiersdorf Inc

NDC Product
Human Otc Drug

Eucerin Daily Protection Face
NDC 10356-323

Generic Name
Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc O...
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Eucerin Daily Hydration
NDC 10356-328

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

Eucerin Daily Hydration
NDC 10356-335

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

Eucerin Eczema Relief Body
NDC 10356-365

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

Eucerin Face Immersive Hydration
NDC 10356-385

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

Eucerin Radiant Tone
NDC 10356-395

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Combe Incorporated

NDC Product
Human Otc Drug

Vagistat 3
NDC 11509-0081

Generic Name
Miconazole Nitrate
Dosage Form
Kit
Route
N/A
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Vagisil Brand Vagistat
NDC 11509-0825

Generic Name
Miconazole Nitrate
Dosage Form
Cream
Route
Vaginal
Marketing
ANDA
Active Listing

Cosette Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Prochlorperazine
NDC 0713-0135

Generic Name
Prochlorperazine
Dosage Form
Suppository
Route
Rectal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Promethegan
NDC 0713-0526

Generic Name
Promethazine Hydrochloride
Dosage Form
Suppository
Route
Rectal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Promethegan
NDC 0713-0536

Generic Name
Promethazine Hydrochloride
Dosage Form
Suppository
Route
Rectal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nystatin
NDC 0713-0678

Generic Name
Nystatin Cream
Dosage Form
Cream
Route
Topical
Marketing
ANDA
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

Sarna
NDC 0316-0256

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

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

NDC Product
Human Prescription Drug

Clobetasol Propionate
NDC 0168-0163

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

Alclometasone Dipropionate
NDC 0168-0263

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

Clobetasol Propionate
NDC 0168-0293

Generic Name
Clobetasol Propionate
Dosage Form
Gel
Route
Topical
Marketing
ANDA
Active Listing

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

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 0168-0201

Generic Name
Clindamycin Phosphate
Dosage Form
Solution
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clindamycin Phosphate
NDC 0168-0202

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

Clindamycin Phosphate
NDC 0168-0203

Generic Name
Clindamycin Phosphate
Dosage Form
Lotion
Route
Topical
Marketing
ANDA
Active Listing

Fougera Pharmaceuticals, LLC

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 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 Baby Eczema Soothing
NDC 0299-4140

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

Cetaphil Hydrating Face Sunscreen Spf 35
NDC 0299-4142

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

Cetaphil Eczema Rapid Relief Cream
NDC 0299-4144

Generic Name
Colloidal Oatmeal
Dosage Form
Cream
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

Genuine Virgin Aloe Corporation

NDC Product
Human Otc Drug

Triderma Pain Relief
NDC 10738-073

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

GlaxoSmithKline LLC

NDC Product
Human Prescription Drug

Lamictal Xr
NDC 0173-0754

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

Lamictal Xr
NDC 0173-0755

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

Lamictal Xr
NDC 0173-0756

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

Lamictal Xr
NDC 0173-0757

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

Lamictal Xr
NDC 0173-0758

Generic Name
Lamotrigine
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lamictal Xr
NDC 0173-0759

Generic Name
Lamotrigine
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lamictal Xr
NDC 0173-0760

Generic Name
Lamotrigine
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lamictal Xr
NDC 0173-0761

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

Lamictal Xr
NDC 0173-0781

Generic Name
Lamotrigine
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Nexium 24hr
NDC 0573-2450

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Nexium 24hr Clearminis
NDC 0573-2452

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
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

Henry Schein

NDC Product
Human Otc Drug

Hydrocortisone
NDC 0404-0166

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

Henry Schein, Inc.

NDC Product
Human Prescription Drug

Nitrostat
NDC 0404-9800

Generic Name
Nitroglycerin Tablet
Dosage Form
Tablet
Route
Sublingual
Marketing
NDA
Active Listing

Humco Holding Group, Inc.

NDC Product
Human Otc Drug

Lidocaine Pain Relief Roll-on
NDC 0395-9130

Generic Name
Lidocaine 4%
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Kao USA Inc.

NDC Product
Human Otc Drug

Hello Sunday Bestseller Daily Spf Duo
NDC 10596-003

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Kit
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

L Perrigo Company

NDC Product
Human Otc Drug

Good Sense Miconazole 7
NDC 0113-0214

Generic Name
Miconazole Nitrate
Dosage Form
Cream
Route
Vaginal
Marketing
ANDA
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Dual Action Complete
NDC 0113-0032

Generic Name
Famotidine, Calcium Carbonate And Magnesium Hydroxide
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Miconazole 3
NDC 0113-0081

Generic Name
Miconazole Nitrate
Dosage Form
Kit
Route
N/A
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Esomeprazole Magnesium
NDC 0113-0651

Generic Name
Esomeprazole
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Miconazole 7
NDC 0113-0825

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

Good Sense Esomeprazole Magnesium
NDC 0113-0898

Generic Name
Esomeprazole
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Esomeprazole Magnesium
NDC 0113-2022

Generic Name
Esomeprazole
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Injoy Heartburn Relief
NDC 0113-6023

Generic Name
Famotidine, Calcium Carbonate And Magnesium Hydroxide
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Dual Action Complete
NDC 0113-7050

Generic Name
Famotidine, Calcium Carbonate, Magnesium Hydroxide
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing

Major Pharmaceuticals

NDC Product
Human Prescription Drug

Esomeprazole Magnesium
NDC 0904-6581

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Marlex Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Hydroquinone
NDC 10135-724

Generic Name
Hydroquinone
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
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

Mylan Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Candesartan Cilexetil
NDC 0378-3224

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

Candesartan Cilexetil
NDC 0378-3225

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

Candesartan Cilexetil
NDC 0378-3231

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

Candesartan Cilexetil
NDC 0378-3232

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

Halcinonide
NDC 0378-8056

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

Prudoxin
NDC 0378-8130

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

Estradiol
NDC 0378-8770

Generic Name
Estradiol
Dosage Form
Cream
Route
Vaginal
Marketing
ANDA
Active Listing

Nature's Innovation, Inc

NDC Product
Human Otc Drug

Naturasil Mite Be Gone
NDC 10893-430

Generic Name
Sulfur
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Nature's Innovation, Inc.

NDC Product
Human Otc Drug

Naturasil Tinea Versicolor Relief
NDC 10893-241

Generic Name
Sulfur
Dosage Form
Lotion
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Naturasil Scabies
NDC 10893-420

Generic Name
Sulfur
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Naturasil Mite B Gone
NDC 10893-530

Generic Name
Sulfur
Dosage Form
Lotion
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Naturasil Mite B Gone Treatment Kit
NDC 10893-531

Generic Name
Sulfur, Thuja Occidentalis
Dosage Form
Kit
Route
N/A
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Nice-Pak Products, LLC

NDC Product
Human Otc Drug

Moisturizing Sunscreen Spf 30
NDC 11344-559

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

Sunscreen For Babies Spf 50
NDC 11344-947

Generic Name
Avobenzone, Homosalate, Octisalate
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Padagis US LLC

NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 0574-7110

Generic Name
Morphine Sulfate
Dosage Form
Suppository
Route
Rectal
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 0574-7112

Generic Name
Morphine Sulfate
Dosage Form
Suppository
Route
Rectal
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 0574-7114

Generic Name
Morphine Sulfate
Dosage Form
Suppository
Route
Rectal
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 0574-7116

Generic Name
Morphine Sulfate
Dosage Form
Suppository
Route
Rectal
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Compro
NDC 0574-7226

Generic Name
Prochlorperazine
Dosage Form
Suppository
Route
Rectal
Marketing
ANDA
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 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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Azulfidine En-tabs
NDC 0013-0102

Generic Name
Sulfasalazine
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
NDA
Active Listing

Port Jervis Laboratories, Inc

REVLON

NDC Product
Human Otc Drug

Ceramide Premiere Broad Spectrum Spf 30
NDC 10967-669

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

Flawless Future Spf 30
NDC 10967-683

Generic Name
Octinoxate, Octisalate, Oxybenzone, Avaobenzone
Dosage Form
Emulsion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Revlon

NDC Product
Human Otc Drug

Prevage Anti-aging Eye Cream Spf 15
NDC 10967-685

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

Revlon Consumer Products Corp

NDC Product
Human Otc Drug

Hi And Dri Roll On
NDC 10967-786

Generic Name
Aluminum Chlorohydrate
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hi And Dri Antiperspirant Roll On
NDC 10967-787

Generic Name
Aluminum Chlorohydrate
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Rugby Laboratories

NDC Product
Human Otc Drug

Rugby Capsaicin Cream
NDC 0536-1264

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

Acid Reducer
NDC 0536-1322

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

SMASHBOX BEAUTY COSMETICS, INC

Sandoz Inc

NDC Product
Human Prescription Drug

Clarithromycin
NDC 0781-6022

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

Clarithromycin
NDC 0781-6023

Generic Name
Clarithromycin
Dosage Form
For Suspension
Route
Oral
Marketing
ANDA
Active Listing

Sun Pharmaceutical Industries, Inc.

NDC Product
Human Prescription Drug

Halog
NDC 10631-094

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

Teva Pharmaceuticals USA, Inc.

NDC Product
Drug For Further Processing

NDC 0093-7909

Generic Name
Tiopronin
Dosage Form
Tablet, Sugar Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Tiopronin
NDC 0093-7909

Generic Name
Tiopronin
Dosage Form
Tablet, Sugar Coated
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

The Mentholatum Company

NDC Product
Human Otc Drug

Mentholatum Lidocaine Ice
NDC 10742-1389

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

Ultra Strength Muscle Rub
NDC 10742-6000

Generic Name
Camphor, Menthol, Methyl Salicylate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mentholatum Lidocaine Heat
NDC 10742-8386

Generic Name
Lidocaine Hcl
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
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

Vi-Jon, LLC

NDC Product
Human Otc Drug

Avobenzone, Homosalate, Octisalate
NDC 0869-9055

Generic Name
Avobenzone, Homosalate, Octisalate
Dosage Form
Lotion
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

WALGREEN CO.

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 0363-0508

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Acid Reducer
NDC 0363-1008

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

WALGREEN COMPANY

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 Dry Touch Broad Spectrum Spf 55
NDC 0363-0965

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

WALGREENS

NDC Product
Human Otc Drug

Hemorrhoidal Pain Relief Cream
NDC 0363-9127

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

WALGREENS COMPANY

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 0363-0772

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Walgreen Co.

NDC Product
Human Otc Drug

Walgreens Eczema Relief
NDC 0363-0357

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

Walgreens Unscented Pain Relieving
NDC 0363-6752

Generic Name
Lidocaine Hydrochloride, Benzyl Alcohol
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreen Company

NDC Product
Human Otc Drug

Miconazole 3
NDC 0363-0081

Generic Name
Miconazole Nitrate
Dosage Form
Kit
Route
N/A
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Acid Reducer Complete
NDC 0363-0511

Generic Name
Famotidine, Calcium Carbonate And Magnesium Hydroxide
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Acid Reducer Complete
NDC 0363-0713

Generic Name
Famotidine, Calcium Carbonate, Magnesium Hydroxide
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 0363-1699

Generic Name
Esomeprazole
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Acid Reducer Complete
NDC 0363-4036

Generic Name
Famotidine, Calcium Carbonate, Magnesium Hydroxide
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Omeprazole
NDC 0363-4099

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

Omeprazole
NDC 0363-6089

Generic Name
Omeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 0363-7223

Generic Name
Esomeprazole
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Walgreens Pain Relieving Foot Pain Relief
NDC 0363-9379

Generic Name
Apis Mellifera, Gelsemium Sempervirens Whole, And Pseudognap...
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Walgreens

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

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

Esomeprazole Magnesium
NDC 0363-1353

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

Walgreens Co

NDC Product
Human Otc Drug

Walgreens Cool N Heat Lidocaine
NDC 0363-7801

Generic Name
Lidocaine Hcl 4%
Dosage Form
Gel
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

Omeprazole Magnesium
NDC 0363-0042

Generic Name
Omeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 0363-3298

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Hydrocortisone
NDC 0363-9981

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

Weeks & Leo Compnay, INC.

NDC Product
Human Otc Drug

Oxify
NDC 11383-002

Generic Name
Lidocaine 5%
Dosage Form
Cream
Route
Topical
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

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