Home NDC 0067-2021-80 Excedrin
Product NDC 0067-2021
Requested package NDC 0067-2021-80
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 1 of 79 · 1,579 matching rows.
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 0067-2021-80 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