Mucinex DM

Product NDC
66715-9724
11-digit product format
667159724
Labeler code
66715
Product ID
66715-9724_075d4215-dba2-3d49-e063-6394a90a1e25
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA021620
Marketing category
NDA
Marketing start
2010-05-10
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 9D2RTI9KYH
Rxcui1298324

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
66715-9724-1Mucinex DM1 in 1 CARTONTABLET, EXTENDED RELEASE18
66715-9724-1Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE28

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
DextromethorphanACTIVE MOIETY7355X3ROTSMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
carbomer homopolymer type B (allyl pentaerythritol crosslinked)INACTIVE INGREDIENTHHT01ZNK31MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9724MUCINEX DM, CVP HEALTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM, TRAVEL BASIX (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, Legacy NDC, 2 package rows20231011_c274b05c-8f05-4980-9a93-77affb322e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNc274b05c-8f05-4980-9a93-77affb322e578
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDc274b05c-8f05-4980-9a93-77affb322e578
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYc274b05c-8f05-4980-9a93-77affb322e578

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9724-1667159724011 POUCH in 1 CARTON (66715-9724-1) / 2 TABLET, EXTENDED RELEASE in 1 POUCH1 pouch2010-05-100000-00-00NoNoCurrent