Nighttime Cold and Flu Relief

Product NDC
83324-164
11-digit product format
833240164
Labeler code
83324
Product ID
83324-164_1126fad8-8854-417b-8dad-4c2874f6b208
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Dextromethorphan HBr Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
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
83324-164-0883324016408237 mL in 1 BOTTLE, PLASTIC (83324-164-08) 237 ml2024-07-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsQUALITY CHOICE (Chain Drug Marketing Association)2024-04-17HUMAN OTC DRUG LABEL1