Mucus Relief DM Expectorant and Cough Suppressant

Product NDC
67091-314
11-digit product format
670910314
Labeler code
67091
Product ID
67091-314_d794e7e6-3681-4329-9ab8-22de9e94debd
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Winco Foods, LLC.
Application
ANDA206941
Marketing category
ANDA
Marketing start
2017-03-17
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 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
67091-314-20670910314202 BLISTER PACK in 1 CARTON (67091-314-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsWinco Foods, LLC. | Aurohealth LLC | Aurobindo Pharma Limited2023-12-01Human OTC Drug Label5