Home NDC 35916-0709 Acetaminophen , Aspirin and Caffeine
Product NDC 35916-0709
11-digit product format 359160709
Labeler code 35916
Product ID 35916-0709_50037ba9-82af-ab8a-e063-6394a90a0a17
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen , Aspirin and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler Softgel Healthcare Pvt Ltd
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-08
Substance ASPIRIN; ACETAMINOPHEN; 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 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 , Aspirin and Caffeine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 250 mg/1 ACETAMINOPHEN 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 R16CO5Y76E Internal UNII lookup 362O9ITL9D Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35916-0709-1 Acetaminophen , Aspirin and Caffeine 1500 in 1 BAG CAPSULE 1500 2
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 1 of 83 · 1,657 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35916-0709-1 35916070901 1500 CAPSULE in 1 BAG (35916-0709-1) 1500 capsule 2026-01-10 No No Current