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 70 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC a71074a6-cc19-4bb3-8c84-4e82a8906801 2024-04-22 Warnings Exact identifier application number: M013 Regular Strength Acetaminophen ACETAMINOPHEN KROGER COMPANY 0fe995cd-f974-db04-e063-6294a90a3355 2024-04-18 Warnings Exact identifier application number: M013 Regular Strength Aspirin 325 mg ASPIRIN Kroger 0fc3193d-af4e-ff3a-e063-6294a90a2743 2024-04-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dye Free ACETAMINOPHEN KROGER COMPANY 0fec66b4-3a2a-63d1-e063-6294a90a6d72 2024-04-17 Warnings Exact identifier application number: M013 aspirin low dose chewable ASPIRIN Time-Cap Labs, Inc 5d56618c-8ea2-42ea-a9f2-339bd0055ddd 2024-04-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN P & L Development, LLC 0058175f-3474-40c3-a046-6cfaec86d84b 2024-04-16 Warnings Exact identifier application number: M013 Handy Solutions Headache Pain Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Navajo Manufacturing Company Inc. e5481abe-6971-2bc5-e053-2995a90ae895 2024-04-15 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN Major Pharmaceuticals 243a5cff-e506-434b-ab19-1a6ac53f8533 2024-04-15 Warnings Exact identifier application number: M013 Dye Free Pain Reliever Childrens ACETAMINOPHEN P & L Development, LLC 45ddcaad-d416-4d7c-a84a-43548d5c5d3b 2024-04-15 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 65bf1556-f25a-9439-e053-2a91aa0a3194 2024-04-15 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e 2024-04-13 Warnings Exact identifier application number: M013 infants pain relief ACETAMINOPHEN Publix Super Markets Inc 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 2024-04-13 Warnings Exact identifier application number: M013 Mommys Bliss Childrens Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 08b9eaf7-70d1-640f-e063-6394a90a8d3b 2024-04-12 Warnings Exact identifier application number: M013 Mommys Bliss Infants Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 05e26650-81b3-d7b1-e063-6394a90a14ed 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief CHILDRENS PAIN RELIEF Allegiant Health 7381dd26-c507-4d02-b989-cfd96e02f495 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief Dye-Free ACTEAMINOPHEN WinCo Foods, LLC 5ee134b3-b8e9-4621-b0a1-a84d9867ccba 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN WALGREENS 0b1d086f-7be1-5072-e063-6394a90a11e6 2024-04-10 Warnings Exact identifier application number: M013 Dye Free Infants Pain and Fever ACETAMINOPHEN WALGREENS 0b1d88d8-56ff-9e9d-e063-6394a90a015c 2024-04-09 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE H E B 4d572228-3141-4539-9c3d-2fd06e94eee3 2024-04-09 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 1b5ff867-5442-4cf8-bd1e-530093cc88f8 2024-04-05 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