Home NDC 0067-2001 Excedrin
Product NDC 0067-2001
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 71 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dye Free Infants Pain and Fever ACETAMINOPHEN WALGREENS 0b1d88d8-56ff-9e9d-e063-6394a90a015c 2024-04-09 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE H E B 4d572228-3141-4539-9c3d-2fd06e94eee3 2024-04-09 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 1b5ff867-5442-4cf8-bd1e-530093cc88f8 2024-04-05 Warnings Exact identifier application number: M013 ndc (product): 0067-2001 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 0faa3592-4d56-4645-9a0e-066e0bdfebb6 2024-04-05 Warnings Exact identifier application number: M013 Pain Relief Childrens Dye Free ACETAMINOPHEN H E B 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 2024-04-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN H E B edb321dd-e5cb-4031-a8a8-efce9e86fe16 2024-04-03 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN H E B a0c0277e-50aa-4328-8f93-ab20c6176b2b 2024-04-03 Warnings Exact identifier application number: M013 Regular Strength Enteric coated aspirin ASPIRIN Bryant Ranch Prepack bda805ab-7f37-405d-a144-4e06ad9a29a1 2024-04-03 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Family Dollar (FAMILY WELLNESS) 650cb15e-c448-4df3-b0f8-4398be05d841 2024-03-27 Warnings Exact identifier application number: M013 Good Sense Effervescent Pain Relief ASPIRIN Perrigo Direct, Inc. 103027a7-2f0e-8d8c-e063-6294a90aedc7 2024-03-26 Warnings Exact identifier application number: M013 rugby infants acetaminophen ACETAMINOPHEN Rugby Laboratories 8aa9ac68-ca61-4163-a876-52034138c1ea 2024-03-25 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 08a18481-f029-f01f-e063-6294a90aac65 2024-03-21 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 0d106fa2-2a77-deb2-e063-6394a90a2dac 2024-03-21 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 872c5220-a379-4dc1-b99c-f11ebb82db35 2024-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 79886972-47a4-44c5-a131-1a691a328103 2024-03-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 5ffcc78d-9163-4cb4-8811-ae9f0142806a 2024-03-18 Warnings Exact identifier application number: M013 ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER HF Acquisition Co LLC, DBA HealthFirst 13e621dc-b2b4-98fd-e063-6394a90acc75 2024-03-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN CVS PHARMACY, INC 097a9c98-a092-400d-9600-6797b0b9a50c 2024-03-15 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets and Excedrin Tension Headache ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC 978a9d27-6d41-42cb-a193-11314923d2ac 2024-03-14 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC b3812d27-40af-40d7-864a-dfa4ae34cb9e 2024-03-14 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 0067-2001-01 00067200101 2 TABLET, FILM COATED in 1 POUCH (0067-2001-01) 2021-01-31 0000-00-00 No No Current 0067-2001-02 00067200102 1 BOTTLE in 1 CARTON (0067-2001-02) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current 0067-2001-03 00067200103 1 BOTTLE in 1 CARTON (0067-2001-03) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current 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 0067-2001-05 00067200105 1 BOTTLE in 1 CARTON (0067-2001-05) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-03-15 0000-00-00 No No Current 0067-2001-06 00067200106 1 BOTTLE in 1 CARTON (0067-2001-06) / 125 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current 0067-2001-07 00067200107 1 BOTTLE in 1 CARTON (0067-2001-07) / 200 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current 0067-2001-08 00067200108 1 BOTTLE in 1 CARTON (0067-2001-08) / 300 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-03-15 0000-00-00 No No Current 0067-2001-09 00067200109 1 BOTTLE in 1 CARTON (0067-2001-09) / 250 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current 0067-2001-14 00067200114 1 VIAL in 1 BLISTER PACK (0067-2001-14) / 8 TABLET, FILM COATED in 1 VIAL 1 vial 2021-01-31 No No Current