Acetaminophen, Aspirin, Caffeine

Product NDC
82804-008
11-digit product format
828040008
Labeler code
82804
Product ID
82804-008_af8b30a0-7a56-4557-8404-cc8059fcd6bc
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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 formatDescriptionMarketing startSampleExclude flagStatus
82804-008-308280400083030 TABLET, FILM COATED in 1 BOTTLE (82804-008-30) 2023-10-05NoNoHistorical
82804-008-608280400086060 TABLET, FILM COATED in 1 BOTTLE (82804-008-60) 2023-10-05NoNoHistorical
82804-008-908280400089090 TABLET, FILM COATED in 1 BOTTLE (82804-008-90) 2023-10-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
5004-RugbyProficient Rx LP2023-11-01HUMAN OTC DRUG LABEL1