Nite Time Cold and Flu Relief

Product NDC
76162-026
11-digit product format
761620026
Labeler code
76162
Product ID
76162-026_b08572e7-e4b1-41fe-bc12-ed0c3300a906
Type
HUMAN OTC DRUG
Nonproprietary name
Nite Time Cold and Flu Relief
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TopCo Associates, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
V9BI9B5YI2DOXYLAMINE SUCCINATE562-10-7DOXYLAMINE SUCCINATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-026-16761620026162 BLISTER PACK in 1 CARTON (76162-026-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2023-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
418 - NiteTime Cold and Flu ReliefTopCo Associates, LLC2023-10-31HUMAN OTC DRUG LABEL3