REVASOL NIGHTTIME COLD AND FLU
REVASOL NIGHTTIME COLD&FLU
Approved
Approval ID
30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 21, 2025
Manufacturers
FDA
Rnv LLC
DUNS: 118917568
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Dextromethorphan HBr and Doxylamine succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84379-276
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr and Doxylamine succinate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2025
FDA Product Classification
INGREDIENTS (14)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ACETAMINOPHENActive
Quantity: 650 mg in 30 mL
Code: 362O9ITL9D
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 30 mL
Code: 9D2RTI9KYH
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DOXYLAMINE SUCCINATEActive
Quantity: 12.5 mg in 30 mL
Code: V9BI9B5YI2
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SORBITOL SOLUTION 70%Inactive
Code: 8KW3E207O2
Classification: IACT