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 72 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Tension Headache ACETAMINOPHEN, CAFFEINE Haleon US Holdings LLC 12c074d1-81ac-47d2-8747-b018cda0058a 2024-03-13 Warnings Exact identifier application number: M013 Menstrual Complete ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE Strive Pharmaceuticals Inc. 78c12459-3b27-4ed0-943d-520794eb438d 2024-03-07 Warnings Exact identifier application number: M013 Pain Reliever fever Reducer Extra Strength ACETAMINOPHEN CVS Pharmacy 7b5263ad-01b7-4fc5-9384-4da8efe89e35 2024-03-06 Warnings Exact identifier application number: M013 Excedrin Extra Strength Geltabs ACETAMINOPHEN, ASPRIN, CAFFEINE Haleon US Holdings LLC 11a8439b-0159-4351-b0f5-fe7fad6a33c0 2024-03-05 Warnings Exact identifier application number: M013 Winco Foods Effervescent Pain Relief ASPIRIN Winco Foods, LLC 128afdd7-a9d1-8957-e063-6294a90af569 2024-03-05 Warnings Exact identifier application number: M013 Aspirin Low Dose Safety Coated ASPIRIN Care One (Retail Business Services, LLC.) 6659e103-fa03-4de0-af42-d2fbd548a87c 2024-03-05 Warnings Exact identifier application number: M013 Dolex Children Pain and Fever ACETAMINOPHEN Pharmadel LLC f9158463-aeb1-5de0-e053-6294a90a748b 2024-03-04 Warnings Exact identifier application number: M013 SEDALMEX FORTE ACETAMINOPHEN, ASPIRIN, CAFFEINE Belmora LLC 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d 2024-02-28 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AMERISOURCE BERGEN 2b923a97-836c-4dac-a8c0-3047a35fb62e 2024-02-23 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL BJWC (Berkley & Jensen / BJ's) b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 2024-02-22 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack 31a41976-7f65-42d7-acf5-de9c2c5ca58e 2024-02-20 Warnings Exact identifier application number: M013 Publix Fast Relief Effervescent - Original Flavor ASPIRIN PUBLIX SUPER MARKETS INC. 0a342f72-45fd-3e12-e063-6394a90ae33e 2024-02-16 Warnings Exact identifier application number: M013 Equaline Effervescent Pain Reliever ASPIRIN UNITED NATURAL FOODS, INC. DBA UNFI 0761299a-e913-7665-e063-6394a90a6003 2024-02-16 Warnings Exact identifier application number: M013 TopCare Effervescent Pain Relief ASPIRIN TOPCO ASSOCIATES LLC 075f36e1-110c-e839-e063-6294a90a89d7 2024-02-16 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 115d0b4f-6f0f-79a9-e063-6394a90ab18a 2024-02-14 Warnings Exact identifier application number: M013 PANADOL ACETAMINOPHEN Haleon US Holdings LLC e1799765-c247-42b4-ad6a-8ba7d136abf2 2024-02-06 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC f626ab17-01c9-4493-ba9e-0c8c11146384 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra ACETAMINOPHEN AND CAFFEINE Haleon US Holdings LLC e5c2d88a-d903-4ca0-b895-f27e791dfc4e 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC 9d384e88-5c11-4600-ac6c-a38371570138 2024-02-06 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