Home NDC 0067-2001-01 Excedrin
Product NDC 0067-2001
Requested package NDC 0067-2001-01
11-digit product format 000672001
Labeler code 0067
Product ID 0067-2001_155eb367-99df-1f50-e063-6294a90a21d6
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 2019-03-15
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0067-2001 0067-2001-01 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-2001-01 ExcedrinExtra Strength Pain Reliever 2 in 1 POUCH TABLET, FILM COATED 2 10 0067-2001-02 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-02 ExcedrinExtra Strength Pain Reliever 24 in 1 BOTTLE TABLET, FILM COATED 24 10 0067-2001-03 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-03 ExcedrinExtra Strength Pain Reliever 30 in 1 BOTTLE TABLET, FILM COATED 30 10 0067-2001-04 ExcedrinExtra Strength Pain Reliever 50 in 1 BOTTLE TABLET, FILM COATED 50 10 0067-2001-04 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-05 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-05 ExcedrinExtra Strength Pain Reliever 100 in 1 BOTTLE TABLET, FILM COATED 100 10 0067-2001-06 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-06 ExcedrinExtra Strength Pain Reliever 125 in 1 BOTTLE TABLET, FILM COATED 125 10 0067-2001-07 ExcedrinExtra Strength Pain Reliever 200 in 1 BOTTLE TABLET, FILM COATED 200 10 0067-2001-07 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-08 ExcedrinExtra Strength Pain Reliever 300 in 1 BOTTLE TABLET, FILM COATED 300 10 0067-2001-08 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-09 ExcedrinExtra Strength Pain Reliever 250 in 1 BOTTLE TABLET, FILM COATED 250 10 0067-2001-09 ExcedrinExtra Strength Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 10 0067-2001-14 ExcedrinExtra Strength Pain Reliever 8 in 1 VIAL TABLET, FILM COATED 8 10 0067-2001-14 ExcedrinExtra Strength Pain Reliever 1 in 1 BLISTER PACK TABLET, FILM COATED 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-2001 EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 10 Current NDC, Legacy NDC, 19 package rows 20240407_1b5ff867-5442-4cf8-bd1e-530093cc88f8.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 23 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin 81 mg ASPIRIN HYVEE INC 3e602287-565e-a5b9-e063-6294a90abc17 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN DELAYED RELEASE 81MG ASPIRIN DELAYED RELEASE 81MG Farmacias De Similares TX LLC 3a8a3efc-f0b3-411c-e063-6394a90a84b7 2026-01-13 Warnings Exact identifier application number: M013 Chewable Aspirin 81 mg ASPIRIN HYVEE INC 459f749f-9d23-8752-e063-6394a90a8c81 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN 325 mg ASPIRIN HYVEE INC 459d01df-6ff6-cff6-e063-6394a90ab35c 2026-01-13 Warnings Exact identifier application number: M013 Pain Terminator Extra Strength Pain Relief CAFFEINE, ACETAMINOPHEN, ASPIRIN Wildman Business Group 8ffb02d9-92df-4d2f-a367-1c71490807fb 2026-01-12 Warnings Exact identifier application number: M013 Aspirin Packs ASPIRIN Sina Health Inc 2865a2c3-53fc-ab9a-e063-6394a90a1418 2026-01-12 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 64696f65-415e-4ce1-a5b3-70662fbcb002 2026-01-12 Warnings Exact identifier application number: M013 Aspirin enteric coated low dose ASPIRIN Walgreen Company 186a6270-e3de-4499-88a4-5f723fee3e34 2026-01-12 Warnings Exact identifier application number: M013 Tension Headache ACETAMINOPHEN, CAFFEINE Cardinal Health 110, LLC. DBA Leader 96684e3f-a13e-49c3-b437-d2627e528a2d 2026-01-12 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Family Dollar Services Inc d35d798e-76f1-454d-86f6-ad11c3bf17d8 2026-01-12 Warnings Exact identifier application number: M013 Xpect Acetaminophen ACETAMINOPHEN Cintas Corporation f4aed854-730e-493d-b523-122156e08dde 2026-01-09 Warnings Exact identifier application number: M013 Aspirin ASPIRIN INVAHEALTH INC e5e8a8d5-9174-7975-e053-2a95a90a9aa6 2026-01-08 Warnings Exact identifier application number: M013 Xpect Cold Relief ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL Cintas Corporation 02391d55-32b2-4083-9315-98e9b3650c55 2026-01-08 Warnings Exact identifier application number: M013 pain relief back and body EXTRA STRENGTH ASPIRIN, CAFFEINE Rite Aid Corporation a71392c8-3f5b-4d00-baba-a4055ed68bc1 2026-01-07 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN L.N.K. International, Inc. 8fed703a-9de2-4c76-a783-fcf004f9b890 2026-01-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen c3099892-a8cd-4574-a6f9-041e59e2feae 2026-01-07 Warnings Exact identifier application number: M013 Bactimicina Childrens Pain and Fever ACETAMINOPHEN DLC Laboratories, Inc. bdade270-d813-4178-b594-4951632b6839 2026-01-07 Warnings Exact identifier application number: M013 Goodmeds Extra Strength Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Cabinet Health P.B.C. 02c60967-46d7-49b7-82be-bc3c5fd36484 2026-01-06 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN ARMY AND AIR FORCE EXCHANGE SERVICE a73f8217-9eae-4e2a-b29c-7de3861d0e37 2026-01-06 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation f77f0120-4042-4b11-ba9c-cd35e1cd0bee 2026-01-05 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0067-2001-01 00067200101 2 TABLET, FILM COATED in 1 POUCH (0067-2001-01) 2021-01-31 0000-00-00 No No Current