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 39 of 79 · 1,579 matching rows.
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