Home NDC 0067-2001-04 Excedrin
Product NDC 0067-2001
Requested package NDC 0067-2001-04
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 0067-2001-04 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 64 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tylenol PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Jones Healthcare Group - Packaging Services, Inc 639f4e01-9723-a619-e053-2991aa0a549a 2024-08-27 Warnings Exact identifier application number: M013 Extra Strength Acetaminohpen Adult Rapid Burst Cherry ACETAMINOPHEN Major Pharmaceuticals 9e7543d9-6249-45b5-b67d-c1b439423b9c 2024-08-27 Warnings Exact identifier application number: M013 aspirin ASPIRIN Major Pharmaceuticals 58684138-04d1-44a4-bc52-c5b85d93d7a6 2024-08-23 Warnings Exact identifier application number: M013 Up and Up childrens acetaminophen ACETAMINOPHEN Target Corporation 9c3ba4dd-f51b-46ce-91b8-8b617c7b78da 2024-08-23 Warnings Exact identifier application number: M013 CVS Effervescent Pain Reliever ASPIRIN CVS PHARMACY 0761147f-1337-606e-e063-6394a90abd5d 2024-08-22 Warnings Exact identifier application number: M013 pain reliever ACETAMINOPHEN Walgreen Company 8255900a-2d58-4261-8df7-f28319883570 2024-08-21 Warnings Exact identifier application number: M013 Pain and Fever ACETAMINOPHEN H E B 86a072a9-c3b8-47f7-8598-d66e3d30e762 2024-08-21 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Kroger Company d965eba0-b268-41b2-8e02-5f6d769a44d7 2024-08-18 Warnings Exact identifier application number: M013 equate pain and fever childrens ACETAMINOPHEN Wal-Mart Stores Inc ea68d735-c677-4280-a3a3-ae3eb5ff7462 2024-08-17 Warnings Exact identifier application number: M013 childrens pain and fever ACETAMINOPHEN CVS Pharmacy fac408f0-ebb6-4c72-88ee-2ba85867859c 2024-08-16 Warnings Exact identifier application number: M013 Regular Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad24 2024-08-14 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief - Extra Strength ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 1f926637-a61c-8eb7-e063-6394a90a6502 2024-08-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PAI Holdings, LLC dba PAI Pharma 6ec12573-03d6-40c1-9945-d345b401e062 2024-08-12 Warnings Exact identifier application number: M013 CareOne Infants Acetaminophen ACETAMINOPHEN American Sales Company eacee273-abd7-4ea4-bcaa-7f74abcc9feb 2024-08-07 Warnings Exact identifier application number: M013 infants pain and fever ACETAMINOPHEN Kroger Company 7dbe284a-c0d5-4ac4-8445-611610f3c0fb 2024-08-02 Warnings Exact identifier application number: M013 Dollar General Effervescent Pain Reliever ASPIRIN Dolgencorp, Inc 1deab362-a325-3a00-e063-6294a90a9acd 2024-08-01 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN FSA STORE INC. 1cd6a3e6-1376-0b7b-e063-6394a90af3d1 2024-07-30 Warnings Exact identifier application number: M013 pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Publix Super Markets Inc 42d271b7-b45f-4497-8de2-4e05b4bebfa9 2024-07-17 Warnings Exact identifier application number: M013 basic care acetaminophen pm ACETAMINOPHEN, DIPHENHYDRAMINE HCL Amazon.com Services LLC 64a0084a-e29e-4c1a-8704-13a3e1238f76 2024-07-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Walmart Inc. 152c013a-c81c-f8f9-e063-6294a90a9f23 2024-07-15 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 0067-2001-04 00067200104 1 BOTTLE in 1 CARTON (0067-2001-04) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current