CAFFEINE
UNII 3G6A5W338E

Substance Identification & Data

This profile provides standardized clinical and technical data for Caffeine, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 3G6A5W338E.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 58-08-2 and the RxNorm Concept ID (RxCUI) 1886. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
3G6A5W338E
CAS Registry Number
58-08-2
RxNorm Concept ID
1886

Detailed Substance Profile

Preferred Name
CAFFEINE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
3G6A5W338E
The specific atomic composition represented as a molecular structure string.
InChIKey
C8H10N4O2
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
RYYVLZVUVIJVGH-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C328
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
2519
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
c12c(c(=O)n(c(n1C)=O)C)n(C)cn2

Synonyms and Nomenclature

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

CAFFEINE

Common Names & Synonyms

ANHYDROUS CAFFEINE
ANHYDROUS CAFFEINE [JAN]
ANOQUAN COMPONENT CAFFEINE
CAFERGOT COMPONENT CAFFEINE
CAFFEINE [EP MONOGRAPH]
CAFFEINE [FCC]
CAFFEINE [FHFI]
CAFFEINE [HSDB]
CAFFEINE [IARC]
CAFFEINE [II]
CAFFEINE [MART.]
CAFFEINE [MI]
CAFFEINE [ORANGE BOOK]
CAFFEINE [USP MONOGRAPH]
CAFFEINE [USP-RS]
CAFFEINE [VANDF]
CAFFEINE [WHO-DD]
CAFFEINE [WHO-IP]
CAFFEINE ANHYDROUS [WHO-IP]
CAFFEINE MELTING POINT STANDARD
CAFFEINUM
CAFFEINUM [HPUS]
COFFEINUM [WHO-IP LATIN]
DARVON COMPOUND COMPONENT CAFFEINE
DHC PLUS COMPONENT CAFFEINE
DIMENHYDRINATE IMPURITY C
DIMENHYDRINATE IMPURITY C [EP IMPURITY]
DURVITAN
ESGIC COMPONENT CAFFEINE
EXCEDRIN COMPONENT CAFFEINE
FEMCET COMPONENT CAFFEINE
FIORICET COMPONENT CAFFEINE
FIORINAL COMPONENT CAFFEINE
GUARANINE
INVAGESIC COMPONENT CAFFEINE
INVAGESIC FORTE COMPONENT CAFFEINE
LANORINAL COMPONENT CAFFEINE
MEDIGESIC PLUS COMPONENT CAFFEINE
MIGERGOT COMPONENT CAFFEINE
NORGESIC COMPONENT CAFFEINE
ORPHENGESIC COMPONENT CAFFEINE
ORPHENGESIC FORTE COMPONENT CAFFEINE
PENTOXIFYLLINE IMPURITY F [EP IMPURITY]
SYNALGOS
SYNALGOS-DC COMPONENT CAFFEINE
SYNALGOS-DC-A COMPONENT CAFFEINE
THEINE
THEOPHYLLINE IMPURITY A [EP IMPURITY]
THEOPHYLLINE MONOHYDRATE IMPURITY A [EP IMPURITY]
TRIAD COMPONENT CAFFEINE
VIVARIN
WIGRAINE COMPONENT CAFFEINE

Brand / Trade Names

TREZIX COMPONENT CAFFEINE

Systematic Nomenclature

1,3,7-TRIMETHYLXANTHINE
1H-PURINE-2,6-DIONE, 3,7-DIHYDRO-1,3,7-TRIMETHYL-
METHYLTHEOBROMINE

Technical Codes

FEMA NO. 2224
NSC-5036

NDC Products Containing CAFFEINE

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.
→ Access Business Group LLC 1
→ Acme United Corporation 1
→ Actavis Pharma, Inc. 4
→ Allergan, Inc. 2
→ American Regent, Inc. 1
→ American Sales Company 1
→ Amerisource Bergen 3
→ Aramis Inc. 1
→ Aurolife Pharma, LLC 1
→ AvKARE 1
→ BETTER LIVING BRANDS, LLC 1
→ Bayer HealthCare LLC 1
→ Bayer HealthCare LLC. 8
→ Bell Pharmaceuticals, Inc 2
→ Belmora LLC 2
→ Better Living Brands, LLC 4
→ Bi-Mart 1
→ CLINIQUE LABORATORIES LLC 10
→ Church & Dwight Co., Inc. 1
→ Cintas Corporation 1
→ Cintex Services, LLC 1
→ Cosette Pharmaceuticals, Inc. 1
→ Crown Laboratories 2
→ DSE Healthcare Solutions, LLC 1
→ Deseret Biologicals, Inc. 1
→ ENGLEWOOD LAB, INC. 1
→ EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1
→ ESTEE LAUDER INC 11
→ Galderma Laboratories, L.P. 2
→ Guna spa 1
→ H E B 3
→ Haleon US Holdings LLC 17
→ Hikma Pharmaceuticals USA Inc. 3
→ KROGER COMPANY 1
→ KVK-Tech, Inc. 1
→ Kroger Company 4
→ L. Perrigo Company 3
→ Lannett Company, Inc. 4
→ Lil' Drug Store Products, Inc. 1
→ MAKEUP ART COSMETICS 3
→ MDSolarSciences 8
→ Major Pharmaceuticals 1
→ Meijer Distribution Inc 3
→ Micro Labs Limited 2
→ Mikart, LLC 1
→ NORTHSTAR RX LLC 1
→ Reese Pharmaceutical Co 1
→ Revlon 1
→ Rite Aid Corporation 7
→ Rugby Laboratories 1
→ SOLCO HEALTHCARE US, LLC 1
→ SUNRISE PHARMACEUTICAL, INC 1
→ Safeway 1
→ Safeway, Inc 1
→ Safeway, Inc. 1
→ Sagent Pharmaceuticals 2
→ Sandoz Inc 1
→ Seton Pharmaceuticals LLC 2
→ Shenzhen Shierjie Biological Engineering Co., LTD 1
→ Softgel Healthcare Pvt Ltd 3
→ Sun Pharmaceutical Industries, Inc. 2
→ TARGET 1
→ TARGET CORPORATION 2
→ TARGET Corporation 1
→ TIME CAP LABS 1
→ TIME CAP LABS INC 1
→ Target Corporation 2
→ The Kroger Co. 3
→ Time Cap Labs, Inc 2
→ Topco Associates LLC 2
→ Topco Associates, LLC 2
→ Ultraceuticals 1
→ Ultraceuticals Pty Ltd 1
→ Unifirst First Aid Corporation 4
→ United Natural Foods, Inc. dba UNFI 5
→ WALGREEN CO 1
→ WALGREENS 5
→ WALGREENS CO. 2
→ Wal-Mart Stores Inc 2
→ Walgreen Company 8
→ Walgreens 2
→ Walgreens Co. 1

Access Business Group LLC

Acme United Corporation

NDC Product
Human Otc Drug

Midol Complete
NDC 0924-6010

Generic Name
Acetaminophen, Caffeine, And Pyrilamine Maleate
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Actavis Pharma, Inc.

Allergan, Inc.

American Regent, Inc.

NDC Product
Human Prescription Drug

Caffeine And Sodium Benzoate
NDC 0517-2502

Generic Name
Caffeine And Sodium Benzoate
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
UNAPPROVED DRUG OTHER
Active Listing

American Sales Company

NDC Product
Human Otc Drug

Care One Migraine Relief
NDC 41520-374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Amerisource Bergen

NDC Product
Human Otc Drug

Alert Aid
NDC 46122-457

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

Headache Relief
NDC 46122-690

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Aramis Inc.

Aurolife Pharma, LLC

NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 13107-075

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

AvKARE

BETTER LIVING BRANDS, LLC

NDC Product
Human Otc Drug

Extra Strength Pain Relief
NDC 21130-037

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

Bayer HealthCare LLC

NDC Product
Human Otc Drug

Midol Complete Gelcaps
NDC 0280-8015

Generic Name
Midol Complete
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bayer HealthCare LLC.

NDC Product
Human Otc Drug

Bayer Headache
NDC 0280-0064

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

Alka-seltzer Hangover Relief
NDC 0280-0084

Generic Name
Anhydrous Citric Acid, Aspirin, And Sodium Bicarbonate
Dosage Form
Tablet, Effervescent
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Bayer Rapid Relief
NDC 0280-0103

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

Aspirina Cafeina
NDC 0280-0162

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

Midol Complete
NDC 0280-8005

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

Bayer Rapid Relief Body Pain
NDC 0280-8257

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

Alka-seltzer Extra Strength Pain Relief
NDC 0280-8260

Generic Name
Anhydrous Citric Acid, Aspirin
Dosage Form
Tablet, Effervescent
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bell Pharmaceuticals, Inc

NDC Product
Human Otc Drug

Jet Alert Double Strength
NDC 15579-200

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

Jet Alert Regular Strength
NDC 15579-201

Generic Name
Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Belmora LLC

NDC Product
Human Otc Drug

Sedalmex Forte
NDC 27854-303

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

Cafiaspirina Rapid Headache Relief
NDC 27854-755

Generic Name
Aspirin, Caffeine
Dosage Form
Powder
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Better Living Brands, LLC

NDC Product
Human Otc Drug

Acetaminophen Aspirin And Caffeine
NDC 21130-074

Generic Name
Acetaminophen, Aspirin And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Stay Awake Maximum Strength
NDC 21130-226

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

Menstrual Relief
NDC 21130-930

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

Awake Maximum Strength
NDC 21130-944

Generic Name
Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bi-Mart

NDC Product
Human Otc Drug

Acetaminophen, Aspirin, And Caffeine
NDC 37835-531

Generic Name
Acetaminophen, Aspirin, And Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

CLINIQUE LABORATORIES LLC

NDC Product
Human Otc Drug

Acne Cleansing
NDC 49527-045

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

Acne And Line Correcting Serum
NDC 49527-053

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

Church & Dwight Co., Inc.

Cintas Corporation

NDC Product
Human Otc Drug

Xpect Pain Away Extra Strength
NDC 42961-234

Generic Name
Acetaminophen Aspirin Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Cintex Services, LLC

NDC Product
Human Prescription Drug

Ergotamine Tartrate And Caffeine
NDC 24470-917

Generic Name
Ergotamine Tartrate And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Cosette Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Migergot
NDC 0713-0166

Generic Name
Ergotamine Tartrate And Caffeine
Dosage Form
Suppository
Route
Rectal
Marketing
ANDA
Active Listing

Crown Laboratories

NDC Product
Human Otc Drug

Blue Lizard Sensitive Face Sunscreen
NDC 0316-2056

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

DSE Healthcare Solutions, LLC

NDC Product
Human Otc Drug

Vanquish Extra Strength
NDC 42364-2208

Generic Name
Acetaminophen, Aspirin, And Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Deseret Biologicals, Inc.

NDC Product
Human Otc Drug

Cand Plus
NDC 43742-1759

Generic Name
Hydrastis Canadensis, Berberis Vulgaris, Borax, Saccharum Of...
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

ENGLEWOOD LAB, INC.

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

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 49035-786

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

ESTEE LAUDER INC

Galderma Laboratories, L.P.

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

Guna spa

NDC Product
Human Otc Drug

Guna Sleep Support
NDC 17089-471

Generic Name
Avena Sativa Flowering Top - Caffeine - Matricaria Chamomill...
Dosage Form
Solution/ Drops
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

H E B

NDC Product
Human Otc Drug

Migraine Formula
NDC 37808-374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Menstrual Complete
NDC 37808-389

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

Headache Relief Extra Strength
NDC 37808-586

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

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Excedrin Extra Strength Pain Reliever
NDC 0067-2001

Generic Name
Acetaminophen, Aspirin (nsaid), And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Headache
NDC 0067-2002

Generic Name
Acetaminophen, Aspirin (nsaid), Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Headache
NDC 0067-2003

Generic Name
Acetaminophen, Aspirin (nsaid), Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Geltabs
NDC 0067-2021

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

Excedrin Migraine Geltabs
NDC 0067-2035

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

Excedrin Migraine
NDC 0067-2039

Generic Name
Acetaminophen, Aspirin (nsaid) And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine
NDC 0067-2040

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

Excedrin Migraine Relief
NDC 0067-2042

Generic Name
Acetaminophen, Aspirin (nsaid), Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Pm Triple Action Caplets
NDC 0067-2056

Generic Name
Acetaminophen, Aspirin (nsaid) And Diphenhydramine Citrate
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Tension Headache
NDC 0067-8139

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

Excedrin Migraine
NDC 0067-8201

Generic Name
Acetaminophen, Aspirin (nsaid) And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Pain Reliever
NDC 0067-8202

Generic Name
Acetaminophen, Aspirin (nsaid), And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Pain Reliever
NDC 0067-8203

Generic Name
Acetaminophen, Aspirin (nsaid), And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Panadol Extra
NDC 0135-0620

Generic Name
Acetaminophen And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Dihydroergotamine Mesylate
NDC 24201-463

Generic Name
Dihydroergotamine Mesylate
Dosage Form
Spray
Route
Nasal
Marketing
ANDA
Active Listing

KROGER COMPANY

NDC Product
Human Otc Drug

Stay Awake
NDC 30142-284

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

KVK-Tech, Inc.

NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 10702-253

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Kroger Company

NDC Product
Human Otc Drug

Menstrual Complete
NDC 30142-390

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

Back And Body
NDC 30142-654

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

Migraine Relief
NDC 30142-896

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Headache Relief
NDC 41226-370

Generic Name
Acetaminophen, Aspirin And Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Migraine Formula
NDC 0113-0374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Migraine Formula
NDC 0113-1619

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Headache Relief
NDC 0113-1855

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Lannett Company, Inc.

NDC Product
Human Prescription Drug

Butalbital, Aspirin, And Caffeine
NDC 0527-1552

Generic Name
Butalbital, Aspirin, And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 0527-4094

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Butalbital, Acetaminophen, And Caffeine
NDC 0527-4095

Generic Name
Butalbital, Acetaminophen, And Caffeine Capsules
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Lil' Drug Store Products, Inc.

NDC Product
Human Otc Drug

Midol Complete
NDC 29485-7964

Generic Name
Acetaminophen, Caffeine, And Pyrilamine Maleate Tablet
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

MAKEUP ART COSMETICS

NDC Product
Drug For Further Processing

NDC 40046-0082

Generic Name
Octinoxate, Titanium Dioxide
Dosage Form
Emulsion
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Otc Drug

Studio Fix Fluid Broad Spectrum Spf 15
NDC 40046-0082

Generic Name
Octinoxate, Titanium Dioxide
Dosage Form
Emulsion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

MDSolarSciences

NDC Product
Human Otc Drug

Kidspray Broad Spectrum Sunscreen Spf 40
NDC 49358-001

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

Major Pharmaceuticals

Meijer Distribution Inc

NDC Product
Human Otc Drug

Back And Body Extra Strength
NDC 41250-143

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

Headache Relief Extra Strength
NDC 41250-334

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

Migraine Formula
NDC 41250-374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Micro Labs Limited

NDC Product
Human Prescription Drug

Caffeine Citrate
NDC 42571-244

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

Caffeine Citrate
NDC 42571-346

Generic Name
Caffeine Citrate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Mikart, LLC

NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 46672-053

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

NORTHSTAR RX LLC

Reese Pharmaceutical Co

NDC Product
Human Otc Drug

Reese Headache Powders
NDC 10956-501

Generic Name
Aspirin And Caffeine
Dosage Form
Powder
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Revlon

NDC Product
Human Otc Drug

Revlon Colorstay Light Cover Foundation
NDC 10967-663

Generic Name
Homosalate, Octisalate, Octocrylene, Titanium Dioxide,zinc O...
Dosage Form
Emulsion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Rite Aid Corporation

NDC Product
Human Otc Drug

Migraine Relief
NDC 11822-0374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Tension Headache Aspirin-free
NDC 11822-0428

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

Pain Reliever Extra Strength
NDC 11822-1590

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

Stay Awake
NDC 11822-2260

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

Headache Relief Extra Strength
NDC 11822-3343

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

Menstrual Complete
NDC 11822-3900

Generic Name
Acetaminophen, Caffeine, Pyrilamine Maleate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Rugby Laboratories

NDC Product
Human Otc Drug

Acetaminophen, Aspirin, Caffeine
NDC 0536-1326

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

SOLCO HEALTHCARE US, LLC

NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 43547-686

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

SUNRISE PHARMACEUTICAL, INC

NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 11534-187

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Safeway

NDC Product
Human Otc Drug

Signature Care Migraine Relief
NDC 21130-569

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Safeway, Inc

NDC Product
Human Otc Drug

Acetaminophen, Aspirin And Caffeine
NDC 21130-681

Generic Name
Acetaminophen, Aspirin And Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Safeway, Inc.

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 21130-586

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

Sagent Pharmaceuticals

NDC Product
Human Prescription Drug

Caffeine Citrate
NDC 25021-601

Generic Name
Caffeine Citrate
Dosage Form
Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Caffeine Citrate
NDC 25021-602

Generic Name
Caffeine Citrate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Sandoz Inc

NDC Product
Human Prescription Drug

Butalbital, Aspirin, And Caffeine
NDC 0781-2270

Generic Name
Butalbital, Aspirin, And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Seton Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 13925-535

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Butalbital, Acetaminophen And Caffeine
NDC 13925-536

Generic Name
Butalbital, Acetaminophen And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Shenzhen Shierjie Biological Engineering Co., LTD

NDC Product
Human Otc Drug

Eyelid Cleansing Wipes
NDC 43116-049

Generic Name
Eyelid Cleansing Wipes
Dosage Form
Cloth
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Softgel Healthcare Pvt Ltd

NDC Product
Human Otc Drug

Acetaminophen , Aspirin And Caffeine
NDC 35916-0709

Generic Name
Acetaminophen , Aspirin And Caffeine
Dosage Form
Capsule
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Sun Pharmaceutical Industries, Inc.

NDC Product
Human Prescription Drug

Caffeine Citrate
NDC 47335-289

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

Caffeine Citrate
NDC 47335-290

Generic Name
Caffeine Citrate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

TARGET

NDC Product
Human Otc Drug

Multi-symptom Menstrual Relief
NDC 11673-363

Generic Name
Acetaminophen, Caffeine, Pyrilamine Maleate
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

TARGET CORPORATION

NDC Product
Human Otc Drug

Headache Relief
NDC 11673-070

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

Tension Headache Relief
NDC 11673-839

Generic Name
Acetaminophen-caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

TARGET Corporation

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 11673-686

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

TIME CAP LABS

NDC Product
Human Otc Drug

Extra Pain Relief
NDC 49483-370

Generic Name
Acetaminophen, Aspirin And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

TIME CAP LABS INC

NDC Product
Human Otc Drug

Tension Headache Relief
NDC 49483-373

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

Target Corporation

NDC Product
Human Otc Drug

Up And Up Migraine Relief
NDC 11673-374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Menstrual Relief
NDC 11673-390

Generic Name
Acetaminophen, Caffeine And Pyrilamine Maleate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

The Kroger Co.

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 30142-586

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

Headache Relief Extra Strength
NDC 30142-625

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

Headache Relief Extra Strength
NDC 30142-865

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

Time Cap Labs, Inc

NDC Product
Human Otc Drug

Alert
NDC 49483-343

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

Comfort-time
NDC 49483-347

Generic Name
Acetaminophen, Caffeine, And Pyrilamine Maleate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing

Topco Associates LLC

NDC Product
Human Otc Drug

Topcare Migraine Relief
NDC 36800-533

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Topcare Migraine Relief
NDC 36800-934

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Topco Associates, LLC

NDC Product
Human Otc Drug

Menstrual Complete
NDC 36800-391

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

Awake Maximum Strength
NDC 36800-844

Generic Name
Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Ultraceuticals

Ultraceuticals Pty Ltd

Unifirst First Aid Corporation

NDC Product
Human Otc Drug

Medique Pain Off
NDC 47682-238

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

Medi First Pain Ache
NDC 47682-821

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

Medi First Plus Pain Ache
NDC 47682-921

Generic Name
Aspirin,caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

United Natural Foods, Inc. dba UNFI

NDC Product
Human Otc Drug

Stay Awake
NDC 41163-226

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

Headache Relief
NDC 41163-334

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

Equaline Migraine Formula
NDC 41163-374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Menstrual Relief
NDC 41163-391

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

Stay Awake Maximum Strength
NDC 41163-434

Generic Name
Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

WALGREEN CO

NDC Product
Human Otc Drug

Acetaminophen Aspirin Caffeine
NDC 0363-9680

Generic Name
Acetaminophen Aspirin Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

WALGREENS

NDC Product
Human Otc Drug

Headache Relief
NDC 0363-0770

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

Headache Relief
NDC 0363-7012

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

Tension Headache Relief
NDC 0363-7213

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

Extra Strength Headache Relief
NDC 0363-7214

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

Extra Strength Headache Relief
NDC 0363-8992

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

WALGREENS CO.

Wal-Mart Stores Inc

NDC Product
Human Otc Drug

Stay Awake
NDC 49035-226

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

Headache Relief Extra Strength
NDC 49035-433

Generic Name
Acetaminophen, Aspirin And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreen Company

NDC Product
Human Otc Drug

Migraine Relief
NDC 0363-0374

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Tension Headache Relief
NDC 0363-0572

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

Migraine Relief
NDC 0363-1235

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Awake Maximum Strength
NDC 0363-3440

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

Menstrual Pain Relief
NDC 0363-3900

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

Menstrual Relief
NDC 0363-3909

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

Caffeine
NDC 0363-5009

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

Menstrual Complete Pain Relief
NDC 0363-9390

Generic Name
Acetaminophen, Caffeine, Pyrilamine Maleate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreens

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 0363-0865

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

Headache Relief Extra Strength
NDC 0363-1150

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

Walgreens Co.

NDC Product
Human Otc Drug

Walgreens Pain Relief Powder
NDC 0363-8712

Generic Name
Aspirin And Caffeine
Dosage Form
Powder
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

External Clinical & Regulatory Resources

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