Home NDC 0067-8203-03 Excedrin
Product NDC 0067-8203
Requested package NDC 0067-8203-03
11-digit product format 000678203
Labeler code 0067
Product ID 0067-8203_1560f6d7-7ac0-4591-e063-6394a90a84d4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin (NSAID), and Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-15
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 Pain Reliever
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 0067-8203-02 ExcedrinExtra Strength Pain Reliever 100 in 1 BOTTLE TABLET, FILM COATED 100 4 0067-8203-02 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 4 0067-8203-03 ExcedrinExtra Strength Pain Reliever 200 in 1 BOTTLE TABLET, FILM COATED 200 4 0067-8203-03 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 4 0067-8203-04 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 4 0067-8203-04 ExcedrinExtra Strength Pain Reliever 300 in 1 BOTTLE TABLET, FILM COATED 300 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-8203 EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 4 Current NDC, Legacy NDC, 6 package rows 20240407_0faa3592-4d56-4645-9a0e-066e0bdfebb6.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 83 · 1,657 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 0067-8203-03 00067820303 1 BOTTLE in 1 CARTON (0067-8203-03) / 200 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-01-15 0000-00-00 No No Current