AMAZON

Product NDC
72288-587
11-digit product format
722880587
Labeler code
72288
Product ID
72288-587_6bbe8cc9-7a60-4476-b5cf-b13c5bebff26
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Doxylamine Succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
AMAZON.COM SERVICES LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-16
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2DOXYLAMINE SUCCINATE562-10-7DOXYLAMINE SUCCINATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-587-04722880587041 BOTTLE in 1 CARTON (72288-587-04) / 118 mL in 1 BOTTLE1 bottle2026-02-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amazon Maximum Strength Adult Nighttime Cough DMAMAZON.COM SERVICES LLC2026-03-04HUMAN OTC DRUG LABEL1