Mucus Relief Cough and Congestion DM

Product NDC
71335-1928
11-digit product format
713351928
Labeler code
71335
Product ID
71335-1928_8f419f71-24d6-44c8-ba06-e08d7433103e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1928-17133519280130 TABLET in 1 BOTTLE (71335-1928-1) 30 tablet2021-08-11NoNoHistorical
71335-1928-27133519280220 TABLET in 1 BOTTLE (71335-1928-2) 20 tablet2021-08-11NoNoHistorical
71335-1928-37133519280318 TABLET in 1 BOTTLE (71335-1928-3) 18 tablet2021-08-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Guaifenesin 400 mg - DextromethorphanCaplets 20 mg CapletsBryant Ranch Prepack2024-10-08HUMAN OTC DRUG LABEL101