Home NDC 71679-312 Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60
Product NDC 71679-312
11-digit product format 716790312
Labeler code 71679
Product ID 71679-312_56138f15-d8ff-eff5-e063-6394a90a326a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500mg Pyrilamine Maleate 15mg and Caffeine 60mg Tablets
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; PYRILAMINE MALEATE
Active strength 60; 15 mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [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 500 Pyrilamine Maleate 15 and Caffeine 60
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 60 mg/1 PYRILAMINE MALEATE 15 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 R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1597298 Internal RxNorm 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 49 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 71679-312-00 71679031200 28500 TABLET, FILM COATED in 1 BOX (71679-312-00) 2024-03-07 No No Current 71679-312-20 71679031220 20 TABLET, FILM COATED in 1 BOTTLE (71679-312-20) 2024-03-07 No No Current