Mucinex DM
Mucinex®DM
Approved
Approval ID
588eddc1-fa30-41cc-8ed9-c01319ea21c6
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
RB Health (US) LLC
DUNS: 081049410
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Guaifenesin and Dextromethorphan Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63824-072
Application NumberNDA021620
Product Classification
M
Marketing Category
C73594
G
Generic Name
Guaifenesin and Dextromethorphan Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GUAIFENESINActive
Quantity: 1200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 60 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT