TopCare EXTRA STRENGTH Headache Relief

Product NDC
76162-142
11-digit product format
761620142
Labeler code
76162
Product ID
76162-142_04e4db94-b659-4638-bf24-789208c20830
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-09
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
76162-142-01761620142011 BOTTLE, PLASTIC in 1 CARTON (76162-142-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-11-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EXTRA STRENGTH Headache ReliefTopco Associates LLC2023-11-09HUMAN OTC DRUG LABEL1