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 6 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join childrens fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation a63727c3-64d8-4ae9-8da3-974cae6beed2 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC e4a2566e-48ec-4602-87e3-143398d15f33 2026-07-24 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation 920e7055-7ed1-4db4-9215-f8933078bb7b 2026-07-24 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens c6665c11-9a01-4472-a444-acadb1de0b69 2026-07-23 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 103d109d-f520-409c-8da2-eb6b0fbec891 2026-07-22 Warnings Exact identifier application number: M013 Tylenol PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC ce58105b-f010-47af-8f31-6dd4ce4e9cba 2026-07-22 Warnings Exact identifier application number: M013 GOOD SENSE INFANTS PAIN AND FEVER ACETAMINOPHEN L. Perrigo Company a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7 2026-07-22 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Cardinal Health 107, LLC 7562f4e4-54fa-488c-a199-48ad2632e2a1 2026-07-21 Warnings Exact identifier application number: M013 Medline ACETAMINOPHEN Medline Industries, LP 4b1d7243-b943-4e2b-e063-6294a90a2c4e 2026-07-20 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN LEADER/ Cardinal Health 110, Inc. 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d 2026-07-16 Warnings Exact identifier application number: M013 Rapidol 500 Extra Strength ACETAMINOPHEN Pharmadel LLC 1d9fa7ec-a509-28b2-e063-6294a90a7831 2026-07-16 Warnings Exact identifier application number: M013 equate pain relief ACETAMINOPHEN WALMART INC. 2f9b2550-5476-49ae-b741-54416a40bc29 2026-07-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL HyVee Inc 4f45a750-1220-4a81-801e-bf08c9d117d6 2026-07-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Dr. Reddy's Laboratories Inc. 9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f 2026-07-15 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Family Dollar, Inc. 3f182571-3212-eb29-e063-6294a90a9fa0 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN DOLGENCORP, LLC 955484a6-2a7a-4b15-a9b4-e888ed5de04c 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Geri-Care Pharmaceuticals, Corp 58941782-362d-4436-b365-e909bdbd29a2 2026-07-15 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Major Pharmaceuticals 44730dfb-5062-4015-924b-c30b6c2b19c2 2026-07-13 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Cardinal Health 110, LLC. DBA Leader f1cd0d59-12a8-4ff2-942a-6faa6907ef05 2026-07-13 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen 2c5e80e8-a979-45fb-9297-8ff294280c25 2026-07-13 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