Home NDC 68163-066-24 DRX CHOICE
Product NDC 68163-066
Requested package NDC 68163-066-24
11-digit product format 681630066
Labeler code 68163
Product ID 68163-066_05f96258-7352-4cd3-96ad-b5bba5c510d0
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin (NSAID), Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Raritan Pharmaceuticals Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-14
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 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 DRX CHOICE
Brand name suffix Extra Strength Headache Relief
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308297 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 1 of 77 · 1,530 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68163-066-24 68163006624 24 TABLET, FILM COATED in 1 CARTON (68163-066-24) 2026-08-14 No No Current