MUCINEX INSTASOOTHE
MUCINEX® INSTASOOTHE™ SORE THROAT PLUS COUGH RELIEF
Approved
Approval ID
8d670d91-9e22-45b9-b568-5b62c2133d32
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.
DEXTROMETHORPHAN HYDROBROMIDE and HEXYLRESORCINOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72854-263
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
DEXTROMETHORPHAN HYDROBROMIDE and HEXYLRESORCINOL
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (9)
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ETHYL LACTATEInactive
Code: F3P750VW8I
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HEXYLRESORCINOLActive
Quantity: 2 mg in 1 1
Code: R9QTB5E82N
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 5 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB