Acetaminophen, Aspirin, Caffeine

Product NDC
68071-3914
11-digit product format
680713914
Labeler code
68071
Product ID
68071-3914_437e4fe5-baed-1534-e063-6394a90a22d4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-03
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
R16CO5Y76EASPIRIN50-78-2ASPIRIN
3G6A5W338ECAFFEINE58-08-2CAFFEINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3914-1680713914011 BOTTLE in 1 CARTON (68071-3914-1) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-11-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
5004-RugbyNuCare Pharmaceuticals,Inc.2025-11-13HUMAN OTC DRUG LABEL1