Maximum Strength Mucus DM Extended Release

Product NDC
69842-059
11-digit product format
698420059
Labeler code
69842
Product ID
69842-059_9d11e2a3-e3be-4bf8-b556-b8af9ee9c234
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA206941
Marketing category
ANDA
Marketing start
2017-03-17
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
69842-059-10698420059106 BLISTER PACK in 1 CARTON (69842-059-10) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2017-03-17NoNoHistorical
69842-059-65698420059652 BLISTER PACK in 1 CARTON (69842-059-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-17NoNoHistorical
69842-059-70698420059704 BLISTER PACK in 1 CARTON (69842-059-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2017-03-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsCVS Pharmacy, Inc. | Aurohealth LLC | Aurobindo Pharma Limited2025-08-11Human OTC Drug Label8