Mucus Relief DM

Product NDC
37808-834
11-digit product format
378080834
Labeler code
37808
Product ID
37808-834_8b93ff63-6715-4133-8e69-464becba08b8
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H E B
Application
ANDA209692
Marketing category
ANDA
Marketing start
2023-03-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60; 1200 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
37808-834-14378080834141 BOTTLE, PLASTIC in 1 BOX (37808-834-14) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2023-03-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsH E B2024-08-02HUMAN OTC DRUG LABEL1