Daytime Severe Cold and Cough

Product NDC
37808-718
11-digit product format
378080718
Labeler code
37808
Product ID
37808-718_f32e1308-7bd4-4a41-9d9b-035a0fc31833
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 10 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE61-76-7PHENYLEPHRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-718-8337808071883245 mL in 1 BOTTLE, PLASTIC (37808-718-83) 245 ml2023-03-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsH E B2024-04-08HUMAN OTC DRUG LABEL3