Mucus Relief DM

Product NDC
55319-741
11-digit product format
553190741
Labeler code
55319
Product ID
55319-741_66836093-dec5-4e5e-beae-ed83b4883fb8
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA209692
Marketing category
ANDA
Marketing start
2025-04-01
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-741-145531907411414 BLISTER PACK in 1 CARTON (55319-741-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK14 blister pack2025-04-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsFamily Dollar (FAMILY WELLNESS)2025-10-30HUMAN OTC DRUG LABEL3
Drug FactsFamily Dollar (FAMILY WELLNESS)2025-02-24HUMAN OTC DRUG LABEL2