Home NDC 71679-307 Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
Product NDC 71679-307
11-digit product format 716790307
Labeler code 71679
Product ID 71679-307_561393c6-f876-f94a-e063-6294a90a151c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Health Pharma USA LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-07
Substance CAFFEINE; ASPIRIN
Active strength 65; 250 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 2027-12-31
Current FDA listing Yes 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 Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 65 mg/1 ASPIRIN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup R16CO5Y76E Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 31 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Walgreen Company b4d8860b-d72f-4789-945e-1c6420a8efab 2025-12-02 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREEN COMPANY f7b304d8-e37c-4ac6-b4a2-1797b92cb832 2025-12-01 Warnings Exact identifier application number: M013 Dye FreeInfants Pain and Fever ACETAMINOPHEN WALGREEN COMPANY 1a304570-88b6-4c16-a8b4-c064bfa5d95a 2025-12-01 Warnings Exact identifier application number: M013 Walgreen Severe Multi-Symptom Cough Cold Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE WALGREENS b48d93fe-bb60-493f-8d1a-b2dc864203c4 2025-12-01 Warnings Exact identifier application number: M013 Multi Symptom Severe Cold and Nighttime Severe Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL WALGREEN CO. 6c4ab613-a587-4ec4-9986-f1d000bc2d23 2025-12-01 Warnings Exact identifier application number: M013 WAG HBP Daytime and Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE WALGREENS CO. ac2f9ce8-e402-4451-a412-e99248a6ecbe 2025-12-01 Warnings Exact identifier application number: M013 Walgreen Day Time NightTime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN WALGREENS CO. 5505217a-9679-4668-bdab-5d4553a47c56 2025-12-01 Warnings Exact identifier application number: M013 CAREALL Aspirin ASPIRIN New World Imports, Inc 58a371d4-1f00-4fda-8e08-80610c58505a 2025-12-01 Warnings Exact identifier application number: M013 CareALL Non Aspirin Extra Strength ACETAMINOPHEN New World Imports, Inc da05a1a1-35b4-4787-8c56-12e369f18ff0 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 80a699b9-bf5c-4765-9e20-ccbc7e3ace7a 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 66244cdb-2680-4fa8-890d-32aefd490038 2025-12-01 Warnings Exact identifier application number: M013 Family Wellness Childrens Pain Reliever 574 ACETAMINOPHEN Family Dollar Services, Inc. 902c1136-04d2-41f0-81c6-412663cdf378 2025-12-01 Warnings Exact identifier application number: M013 WalgreenChildrens Pain Fever ACETAMINOPHEN WALGREENS CO. 2f757cde-2604-4ca4-b54e-e444f3757cdd 2025-11-26 Warnings Exact identifier application number: M013 Walgreen Childrens Pain plus Fever ACETAMINOPHEN WALGREENS CO. 29ca2855-3c07-435d-a8e1-2997fcedd088 2025-11-26 Warnings Exact identifier application number: M013 Walgreens Childrens Cold plus Cough plus Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE WALGREENS CO. 8714d4e6-3a3b-48c8-8ac1-51b933a2ceac 2025-11-26 Warnings Exact identifier application number: M013 Pain Reliever, 24/7 Life by 7-Eleven ACETAMINOPHEN TABLET, FILM COATED Lil' Drug Store Products, Inc. 44828b89-2563-b233-e063-6294a90ab124 2025-11-26 Warnings Exact identifier application number: M013 MEMBERS MARK ACETAMINOPHEN ACETAMINOPHEN Sam's West Inc 03e831d4-8060-4633-9d02-e77100063fb4 2025-11-26 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dissolve Packs ACETAMINOPHEN WALGREENS CO. ea0f265f-7d64-4731-beda-0bb841dd1ad7 2025-11-25 Warnings Exact identifier application number: M013 Sore Throat Logenzes Sore Throat BENZOCAINE AND MENTHOL ATLANTIC BIOLOGICALS CORP. 71a80e13-bda3-40fb-b4e7-45e9985e707c 2025-11-24 Warnings Exact identifier application number: M013 better living brands childrens fever and pain reliver ACETAMINOPHEN BETTER LIVING BRANDS LLC c13ced61-c491-4fc2-b83f-78c6d9ad8546 2025-11-20 Warnings Exact identifier application number: M013
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71679-307-00 71679030700 30000 TABLET, FILM COATED in 1 DRUM (71679-307-00) 2024-03-07 No No Current 71679-307-03 71679030703 300 TABLET, FILM COATED in 1 BOTTLE (71679-307-03) 2024-03-07 No No Current