MUCINEX INSTASOOTHE
MUCINEX® InstaSoothe™
Approved
Approval ID
0d99237c-0b52-0af6-e063-6394a90aba14
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Oct 11, 2024
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72854-267
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
DEXTROMETHORPHAN HYDROBROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2024
FDA Product Classification
INGREDIENTS (8)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ISOMALTInactive
Code: S870P55O2W
Classification: IACT
HYDROGENATED STARCH HYDROLYSATEInactive
Code: 27F77DSJ5V
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 5 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB