FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-741-14Mucus Relief DM14 in 1 CARTONTABLET, EXTENDED RELEASE143
55319-741-14Mucus Relief DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-741MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [FAMILY DOLLAR (FAMILY WELLNESS)]2Current NDC, 2 package rows20250402_ebc1a915-f643-4878-9d7a-67a9c6a26b20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNebc1a915-f643-4878-9d7a-67a9c6a26b203
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDebc1a915-f643-4878-9d7a-67a9c6a26b203
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYebc1a915-f643-4878-9d7a-67a9c6a26b203

Packages#

Package NDC, 11-digit format, Description table
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 pack2025-04-01NoNoCurrent