D&C RED NO. 7
UNII ECW0LZ41X8

Substance Identification & Data

This profile provides standardized clinical and technical data for D&c Red No. 7, uniquely identified by the FDA Unique Ingredient Identifier (UNII) ECW0LZ41X8.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 5281-04-9 and the RxNorm Concept ID (RxCUI) 1310564. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
ECW0LZ41X8
CAS Registry Number
5281-04-9
RxNorm Concept ID
1310564

Detailed Substance Profile

Preferred Name
D&C RED NO. 7
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
ECW0LZ41X8
The specific atomic composition represented as a molecular structure string.
InChIKey
C18H12N2O6S.Ca
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
PZTQVMXMKVTIRC-RZLHGTIFSA-L
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C71668
National Cancer Institute reference terminology for clinical and research data.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
[Ca+2].c1(/N=N/c2ccc(cc2S([O-])(=O)=O)C)c3ccccc3cc(C([O-])=O)c1O

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for D&c Red No. 7. 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

AKA202
PIGMENT RED 57:1
RED 7

Common Names & Synonyms

2-NAPHTHALENECARBOXYLIC ACID, 3-HYDROXY-4-((E)-(4-METHYL-2-SULFOPHENYL)AZO)-, CALCIUM SALT (1:1)
2-NAPHTHALENECARBOXYLIC ACID, 3-HYDROXY-4-(2-(4-METHYL-2-SULFOPHENYL)DIAZENYL)-, CALCIUM SALT (1:1)
BRILLIANT CARMINE 6B
C.I. 15850:1
CALCIUM SALT OF 3-HYDROXY-4-((4-METHYL-2-SULFOPHENYL)AZO)-2- NAPHTHALENECARBOXYLIC ACID
CI 15850:1
D&C RED 7 CALCIUM LAKE
D&C RED NO. 7
D&C RED NO. 7 [II]
D&C RED NO. 7--CALCIUM LAKE
D&C RED NO. 7--CALCIUM LAKE [II]
DC RED NO. 7
DC RED NO. 7-CALCIUM LAKE
DYE DC RED NO. 7 CALCIUM LAKE
LITHOL RUBINE BK
LITHOL RUBINE BK [USP-RS]
LITHOLRUBINE
PIGMENT RUBINE [MART.]

Systematic Nomenclature

CALCIUM 3-HYDROXY-4-((E)-(4-METHYL-2-SULFONATOPHENYL)DIAZENYL)-2-NAPHTHOATE

NDC Products Containing D&C RED NO. 7

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 (332), only Active Listings are currently displayed.
→ A-S Medication Solutions 1
→ Actavis Pharma, Inc. 2
→ Advanced Rx Pharmacy of Tennessee, LLC 1
→ Advanz Pharma (US) Corp. 1
→ AiPing Pharmaceutical, Inc. 7
→ Amazon.com Services LLC 1
→ American Health Packaging 3
→ American Sales Company 1
→ Aphena Pharma Solutions - Tennessee, LLC 2
→ Apotex Corp 1
→ Apotex Corp. 2
→ Aurobindo Pharma Limited 4
→ AvPAK 1
→ BEL STAR S A 8
→ Bath and Body Works, Inc. 3
→ Bayer HealthCare LLC. 2
→ Black Girl Sunscreen 1
→ BluePoint Laboratories 1
→ Bryant Ranch Prepack 8
→ COOLA, LLC 2
→ COSMAX USA 2
→ COSMAX USA, CORP 2
→ CVS Pharmacy 1
→ Cardinal Health 110, LLC. dba Leader 1
→ Centaur Pharmaceuticals Private Limited 3
→ Chattem, Inc. 1
→ Direct_Rx 1
→ Dolgencorp, LLC 1
→ Golden State Medical Supply, Inc. 4
→ H E B 1
→ H.E.B 1
→ H.E.B. 1
→ Haleon US Holdings LLC 1
→ Iris and Romeo 1
→ KROGER COMPANY 1
→ Kenvue Brands LLC 21
→ L'Oreal USA Products Inc 1
→ L. Perrigo Company 1
→ Lil' Drug Store Products, Inc. 2
→ L�E COSMETICS INC 2
→ MJ Products Association, LLC 4
→ Major Pharmaceuticals 4
→ Morning Star OTC 1
→ Mylan Pharmaceuticals Inc. 4
→ Navajo Manufacturing Company Inc 1
→ NextWave Pharmaceuticals, Inc 1
→ Noxell 1
→ NuCare Pharmaceuticals,Inc. 1
→ PD-Rx Pharmaceuticals, Inc. 1
→ PUBLIX SUPER MARKETS, INC 1
→ Prasco Laboratories 2
→ Preferred Pharmaceuticals Inc. 1
→ Proficient Rx LP 1
→ Publix Super Markets Inc 1
→ Qingdao BAHEAL Pharmaceutical Co., Ltd. 4
→ R J General Corporation 1
→ REVLON 1
→ Rhodes Pharmaceuticals LLC 6
→ Riversol Skincare 1
→ ST. MARY'S MEDICAL PARK PHARMACY 1
→ Safeway 1
→ Sandoz Inc 3
→ Solarium Brands LLC 2
→ SpecGx LLC 4
→ Strategic Sourcing Services LLC 1
→ Suave Brands Co., LLC 1
→ Sun Bum, LLC 10
→ Sun Pharmaceutical Industries, Inc. 3
→ TIRTIR USA Inc. 4
→ Target Corporation 1
→ Teva Pharmaceuticals USA, Inc. 4
→ The Center Brands, LLC 5
→ Trigen Laboratories, LLC 2
→ United Natural Foods, Inc. dba UNFI 1
→ Ventura Corporation LTD 2
→ Vertical Pharmaceuticals, LLC 2
→ Walgreen Company 1
→ Westminster Pharmaceuticals, LLC 3
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1
→ cosnova GmbH 1
→ e.l.f. Cosmetics, Inc. 4

A-S Medication Solutions

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 50090-1869

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Actavis Pharma, Inc.

NDC Product
Human Prescription Drug

Tranylcypromine Sulfate
NDC 0591-5590

Generic Name
Tranylcypromine Sulfate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Advanced Rx Pharmacy of Tennessee, LLC

NDC Product
Human Prescription Drug

Hydroxyzine Hydrochloride
NDC 80425-0376

Generic Name
Hydroxyzine Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Advanz Pharma (US) Corp.

NDC Product
Human Prescription Drug

Parnate
NDC 59212-447

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

AiPing Pharmaceutical, Inc.

NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 11788-080

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

Amitriptyline Hydrochloride
NDC 11788-081

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

Amitriptyline Hydrochloride
NDC 11788-082

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

Celecoxib
NDC 11788-112

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

Celecoxib
NDC 11788-113

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

Celecoxib
NDC 11788-114

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

Celecoxib
NDC 11788-115

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

Amazon.com Services LLC

NDC Product
Human Otc Drug

Basic Care Dual Action Complete
NDC 72288-321

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

American Health Packaging

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 60687-351

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

Hydroxyzine Hydrochloride
NDC 60687-875

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

Morphine Sulfate Extended Release
NDC 68084-158

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

American Sales Company

NDC Product
Human Otc Drug

Careone Acid Reducer Complete
NDC 41520-409

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

Aphena Pharma Solutions - Tennessee, LLC

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 71610-164

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

Bupropion Hydrochloride
NDC 71610-708

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Apotex Corp

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 60505-0157

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Apotex Corp.

NDC Product
Human Prescription Drug

Nilotinib
NDC 60505-3802

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

Nilotinib
NDC 60505-3803

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

Aurobindo Pharma Limited

NDC Product
Human Prescription Drug

Hydroxyzine Hydrochloride
NDC 59651-500

Generic Name
Hydroxyzine Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 59651-500

Generic Name
Hydroxyzine Hydrochloride
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 59651-501

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

Hydroxyzine Hydrochloride
NDC 59651-501

Generic Name
Hydroxyzine Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

AvPAK

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 50268-143

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

BEL STAR S A

Bath and Body Works, Inc.

Bayer HealthCare LLC.

NDC Product
Human Otc Drug

Aspirina Caplets
NDC 0280-0161

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

Bayer Aspirin Extra Strength Caplets
NDC 0280-2020

Generic Name
Bayer Aspirin Extra Strength
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Black Girl Sunscreen

NDC Product
Human Otc Drug

Black Girl Sunscreen Make It Pop
NDC 84204-2261

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

BluePoint Laboratories

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 68001-309

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Bryant Ranch Prepack

NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 63629-4484

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

Bupropion Hydrochloride
NDC 71335-0182

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

Hydroxyzine Hydrochloride
NDC 71335-2776

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

Hydroxyzine Hydrochloride
NDC 71335-3035

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

Hydroxyzine Hydrochloride
NDC 71335-3036

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

Bupropion Hydrochloride
NDC 72162-2097

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

Hydroxyzine Hydrochloride
NDC 72162-2512

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

Hydroxyzine Hydrochloride
NDC 72162-2513

Generic Name
Hydroxyzine Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

COOLA, LLC

COSMAX USA

COSMAX USA, CORP

CVS Pharmacy

NDC Product
Human Otc Drug

Acid Reducer Plus Antacid
NDC 59779-738

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

Cardinal Health 110, LLC. dba Leader

NDC Product
Human Otc Drug

Leader Acid Reducer Complete
NDC 70000-0582

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

Centaur Pharmaceuticals Private Limited

NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 64330-633

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

Amitriptyline Hydrochloride
NDC 64330-634

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

Amitriptyline Hydrochloride
NDC 64330-635

Generic Name
Amitriptyline Hydrochloride
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Chattem, Inc.

NDC Product
Human Otc Drug

Unisom Sleepmelts Nighttime Sleep-aid
NDC 41167-0014

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Direct_Rx

NDC Product
Human Prescription Drug

Bupropion Hcl
NDC 72189-457

Generic Name
Bupropion Hcl
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Dolgencorp, LLC

NDC Product
Human Otc Drug

Dg Health Acid Reducer Complete
NDC 55910-808

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

Golden State Medical Supply, Inc.

NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 51407-796

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

Amitriptyline Hydrochloride
NDC 51407-797

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

Amitriptyline Hydrochloride
NDC 51407-798

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

Bupropion Hydrochloride
NDC 60429-747

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

H E B

NDC Product
Human Otc Drug

Dual Action Complete
NDC 37808-503

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

H.E.B

NDC Product
Human Otc Drug

Heb Shimmer Sunscreen Spf 50
NDC 37808-041

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

H.E.B.

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Chapstick Moisturizer Variety Pack
NDC 0573-1959

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene, White Petro...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing

Iris and Romeo

KROGER COMPANY

NDC Product
Human Otc Drug

Childrens Chewable Allergy Relief
NDC 41226-669

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Kenvue Brands LLC

NDC Product
Human Otc Drug

Pepcid Complete
NDC 16837-298

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

Childrens Benadryl Chewables
NDC 50580-232

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

Childrens Tylenol
NDC 50580-460

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

Childrens Tylenol
NDC 50580-521

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

Childrens Tylenol
NDC 50580-522

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

L'Oreal USA Products Inc

L. Perrigo Company

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

Lil' Drug Store Products, Inc.

NDC Product
Human Otc Drug

Dual Action Pepcid Complete
NDC 29485-6522

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

Pepcid Complete
NDC 66715-9822

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

L�E COSMETICS INC

NDC Product
Human Otc Drug

Ceile Spf 45 Flush Protect
NDC 83103-1000

Generic Name
Sunscreen 45
Dosage Form
Powder
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Ciele Spf 45 Flush Protect
NDC 83103-1001

Generic Name
Sunscreen 45
Dosage Form
Powder
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

MJ Products Association, LLC

NDC Product
Human Otc Drug

Totally Fun After Sun
NDC 72085-145

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

Sea Star Sparkle Spf-50 Mango-tango
NDC 72085-147

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

Sea Star Sparkle Spf-50 Party Cake
NDC 72085-148

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

Sea Star Sparkle Spf-50 Very Berry
NDC 72085-149

Generic Name
Octinoxate, Octisalate, Octocrylene, Zinc Oxide
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Major Pharmaceuticals

NDC Product
Human Prescription Drug

Morphine Sulfate Extended Release
NDC 0904-6558

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

Morphine Sulfate Extended Release
NDC 0904-6559

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

Morphine Sulfate Extended Release
NDC 0904-6560

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

Bupropion Hydrochloride
NDC 0904-6636

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Morning Star OTC

NDC Product
Human Otc Drug

Pepcid Complete
NDC 53209-4001

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

Mylan Pharmaceuticals Inc.

Navajo Manufacturing Company Inc

NDC Product
Human Otc Drug

Pepcid Complete
NDC 67751-202

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

NextWave Pharmaceuticals, Inc

NDC Product
Human Prescription Drug

Quillichew Er
NDC 24478-076

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Tablet, Chewable, Extended Release
Route
Oral
Marketing
NDA
Active Listing

Noxell

NuCare Pharmaceuticals,Inc.

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 68071-2577

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

PD-Rx Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 72789-070

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

PUBLIX SUPER MARKETS, INC

NDC Product
Human Otc Drug

Publix Women Laxative
NDC 41415-121

Generic Name
Bisacodyl
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Prasco Laboratories

NDC Product
Human Prescription Drug

Conjugated Estrogens
NDC 66993-298

Generic Name
Estrogens, Conjugated
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Conjugated Estrogens
NDC 66993-299

Generic Name
Estrogens, Conjugated
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Preferred Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 68788-7988

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Proficient Rx LP

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 82804-123

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Publix Super Markets Inc

NDC Product
Human Otc Drug

Dual Action Complete
NDC 56062-263

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

Qingdao BAHEAL Pharmaceutical Co., Ltd.

NDC Product
Human Prescription Drug

Celecoxib
NDC 70247-006

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

Celecoxib
NDC 70247-007

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

Celecoxib
NDC 70247-008

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

Celecoxib
NDC 70247-009

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

R J General Corporation

NDC Product
Human Otc Drug

Pepcid Complete
NDC 70264-034

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

REVLON

NDC Product
Human Otc Drug

Ea Eight Hr Lip Sheer Tints
NDC 10967-674

Generic Name
Oxybenzone, Padimate O, Petrolatum
Dosage Form
Lipstick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Rhodes Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Ms Contin
NDC 42858-631

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

Ms Contin
NDC 42858-760

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

Morphine Sulfate Extended Release
NDC 42858-802

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

Morphine Sulfate Extended Release
NDC 42858-803

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

Morphine Sulfate Extended Release
NDC 42858-804

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

Morphine Sulfate Extended Release
NDC 42858-805

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

Riversol Skincare

NDC Product
Human Otc Drug

Riversol Tinted Lip Oil
NDC 72019-2120

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

ST. MARY'S MEDICAL PARK PHARMACY

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 60760-781

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Safeway

NDC Product
Human Otc Drug

Acid Reducer Complete
NDC 21130-614

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

Sandoz Inc

NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 0781-1489

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

Amitriptyline Hydrochloride
NDC 0781-1490

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

Amitriptyline Hydrochloride
NDC 0781-1491

Generic Name
Amitriptyline Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Solarium Brands LLC

SpecGx LLC

NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 0406-8320

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

Morphine Sulfate
NDC 0406-8330

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

Morphine Sulfate
NDC 0406-8380

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

Morphine Sulfate
NDC 0406-8390

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

Strategic Sourcing Services LLC

NDC Product
Human Otc Drug

Foster And Thrive Acid Reducer Antacid
NDC 70677-1100

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

Suave Brands Co., LLC

Sun Bum, LLC

Sun Pharmaceutical Industries, Inc.

NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 57664-690

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

Amitriptyline Hydrochloride
NDC 57664-691

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

Amitriptyline Hydrochloride
NDC 57664-692

Generic Name
Amitriptyline Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

TIRTIR USA Inc.

Target Corporation

NDC Product
Human Otc Drug

Up And Up Dual Action Acid Reducer Antacid
NDC 82442-321

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

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Claravis
NDC 0555-1054

Generic Name
Isotretinoin
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Claravis
NDC 0555-1055

Generic Name
Isotretinoin
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Claravis
NDC 0555-1056

Generic Name
Isotretinoin
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Claravis
NDC 0555-1057

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

The Center Brands, LLC

NDC Product
Human Otc Drug

Prequel Lip Visor Spf 30 Clear
NDC 82800-070

Generic Name
Lip 30 Clear
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Prequel Lip Visor Spf 30 Rosedust
NDC 82800-080

Generic Name
Lip 30 Clear
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Prequel Lip Visor Blush Spf 30
NDC 82800-120

Generic Name
Prequel Lip Visor Blush Spf 30
Dosage Form
Lipstick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Prequel Lip Visor Mahogany Spf 30
NDC 82800-130

Generic Name
Prequel Lip Visor Mahogany Spf 30
Dosage Form
Lipstick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Prequel Lip Visor Nude Spf 30
NDC 82800-140

Generic Name
Prequel Lip Visor Nude Spf 30
Dosage Form
Lipstick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Trigen Laboratories, LLC

United Natural Foods, Inc. dba UNFI

NDC Product
Human Otc Drug

Equaline Complete Dual Action
NDC 41163-321

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

Ventura Corporation LTD

Vertical Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Conzip
NDC 68025-072

Generic Name
Tramadol Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Conzip
NDC 68025-073

Generic Name
Tramadol Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing

Walgreen Company

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

Westminster Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 69367-391

Generic Name
Amitriptyline Hydrochloride
Dosage Form
Tablet, Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 69367-392

Generic Name
Amitriptyline Hydrochloride
Dosage Form
Tablet, Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Amitriptyline Hydrochloride
NDC 69367-393

Generic Name
Amitriptyline Hydrochloride
Dosage Form
Tablet, Coated
Route
Oral
Marketing
ANDA
Active Listing

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Premarin
NDC 0046-1103

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

cosnova GmbH

NDC Product
Human Otc Drug

Essence Pout Protector Spf 20 Lip Balm
NDC 84270-001

Generic Name
Homosalate, Octisalate, Zinc Oxide
Dosage Form
Stick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

e.l.f. Cosmetics, Inc.

External Clinical & Regulatory Resources

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