Home NDC 0067-2021 Excedrin
Product NDC 0067-2021
11-digit product format 000672021
Labeler code 0067
Product ID 0067-2021_09d7d5f9-c9f1-4942-8dc8-13ca8e164ce9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Asprin, Caffeine
Dosage form TABLET, COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-09-13
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength 250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Excedrin
Brand name suffix Extra Strength Geltabs
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1 CAFFEINE 65 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup R16CO5Y76E Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 209468 Internal RxNorm lookup 308297 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-2021-20 ExcedrinExtra Strength Geltabs 20 in 1 BOTTLE TABLET, COATED 20 6 0067-2021-20 ExcedrinExtra Strength Geltabs 1 in 1 CARTON TABLET, COATED 1 6 0067-2021-24 ExcedrinExtra Strength Geltabs 1 in 1 CARTON TABLET, COATED 1 6 0067-2021-24 ExcedrinExtra Strength Geltabs 24 in 1 BOTTLE TABLET, COATED 24 6 0067-2021-80 ExcedrinExtra Strength Geltabs 1 in 1 CARTON TABLET, COATED 1 6 0067-2021-80 ExcedrinExtra Strength Geltabs 80 in 1 BOTTLE TABLET, COATED 80 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 ASPIRIN ACTIVE MOIETY R16CO5Y76E EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 CAFFEINE ACTIVE MOIETY 3G6A5W338E EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 MALTITOL INACTIVE INGREDIENT D65DG142WK EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 PEPSIN INACTIVE INGREDIENT GID333S43J EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 SORBITAN MONOLAURATE INACTIVE INGREDIENT 6W9PS8B71J EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-2021 EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [HALEON US HOLDINGS LLC] 6 Current NDC, Legacy NDC, 6 package rows 20240307_11a8439b-0159-4351-b0f5-fe7fad6a33c0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 47 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD REMEDIES Extra Strength Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d642d8e-c154-a970-e063-6294a90a03bf 2025-03-14 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4 2025-03-07 Warnings Exact identifier application number: M013 Redicare Non-Aspirin 500mg REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG Redicare LLC 2f229898-1777-732c-e063-6394a90a76bc 2025-03-04 Warnings, Adverse reactions Exact identifier application number: M013 Major Extra Strength Acetaminophen Liquid ACETAMINOPHEN Major Pharmaceuticals 2f3af4dd-45d5-87b4-e063-6294a90ab3cc 2025-02-28 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs ed9a71d6-a56e-416a-bb89-6d41307efc5a 2025-02-27 Warnings Exact identifier application number: M013 Aspirin ASPIRIN PD-Rx Pharmaceuticals, Inc. 77429b7f-78e4-42c0-8679-ae8da1748848 2025-02-26 Warnings Exact identifier application number: M013 AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES Aero Healthcare faa3a4ef-3c70-06ca-e053-6394a90a512d 2025-02-26 Warnings Exact identifier application number: M013 Bufferin Regular Strength Pain Relief ASPIRIN Genomma Lab USA 3543b2bf-1062-468a-a5dc-eabb2408af8c 2025-02-25 Warnings Exact identifier application number: M013 Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CHEWABLE 80 MG Calmour ae47b027-4f29-45bb-a8bd-812978932835 2025-02-22 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC f9de7c2f-016b-4f40-8b5e-141ad194be97 2025-02-20 Warnings Exact identifier application number: M013 Genexa Acetaminophen PM Extra Strength ACETAMINOPHEN Genexa Inc. d82cf6f3-a291-ca2b-e053-2a95a90a6de1 2025-02-20 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Advagen Pharma Limited 8b9456c9-a56b-4748-adb8-c66d6bf072e8 2025-02-19 Warnings Exact identifier application number: M013 Genexa Childrens Acetaminophen ACETAMINOPHEN Genexa Inc. d89fd9d8-d88e-3968-e053-2a95a90afc5f 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. debfa787-7a48-48b5-94b0-612820524032 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. b16e5dcf-b290-4ff2-a150-4b875647ec9a 2025-02-19 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC bb6533e5-e6a9-488c-b8ab-a6a06e87ede9 2025-02-18 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC c830320e-72ba-48ff-a4cd-250ac5650bf0 2025-02-18 Warnings Exact identifier application number: M013 Aspirina Caplets ASPIRIN Bayer HealthCare LLC. 2e6f5ba8-8e8b-6059-e063-6394a90adcd5 2025-02-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. da7d95af-6583-429d-8d04-e0424f32e9ad 2025-02-17 Warnings Exact identifier application number: M013 GOODYS Mental Alert ASPIRIN AND CAFFEINE Medtech Products Inc. 31ef6d07-d314-4d09-abcd-389ba66cbcc5 2025-02-17 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0067-2021-20 00067202120 1 BOTTLE in 1 CARTON (0067-2021-20) / 20 TABLET, COATED in 1 BOTTLE 1 bottle 2011-09-13 0000-00-00 No No Current 0067-2021-24 00067202124 1 BOTTLE in 1 CARTON (0067-2021-24) / 24 TABLET, COATED in 1 BOTTLE 1 bottle 2011-09-13 0000-00-00 No No Current 0067-2021-80 00067202180 1 BOTTLE in 1 CARTON (0067-2021-80) / 80 TABLET, COATED in 1 BOTTLE 1 bottle 2011-09-13 0000-00-00 No No Current