Mucus Relief DM

Product NDC
55319-734
11-digit product format
553190734
Labeler code
55319
Product ID
55319-734_c81bf0ff-96be-4698-b244-f6f0d4df00f9
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
2023-07-01
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-734-07Mucus Relief DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE15
55319-734-07Mucus Relief DM7 in 1 CARTONTABLET, EXTENDED RELEASE75

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-734MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 2 package rows20230908_b60d1cc6-086c-4483-a101-c5f8d6000969.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNb60d1cc6-086c-4483-a101-c5f8d60009695
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDb60d1cc6-086c-4483-a101-c5f8d60009695
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYb60d1cc6-086c-4483-a101-c5f8d60009695

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-734-07553190734077 BLISTER PACK in 1 CARTON (55319-734-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK7 blister pack2023-07-01NoNoHistorical