Topcare DayTime Cold and Flu Relief

Product NDC
76162-483
11-digit product format
761620483
Labeler code
76162
Product ID
76162-483_c52c261b-a175-4ef6-aefd-42ecbbc34145
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 10 mg/15mL; mg/15mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-483-4076162048340355 mL in 1 BOTTLE (76162-483-40) 355 ml2025-07-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Topco Associates LLC. Cold & Flu Relief Drug FactsTopco Associates LLC2025-09-23HUMAN OTC DRUG LABEL2
Topco Associates LLC. DayTime Cold & Flu Relief Drug FactsTopco Associates LLC2025-07-15HUMAN OTC DRUG LABEL3