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FDA Approval

VICKS FORMULA 44DM

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
April 9, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Dextromethorphan(10 mg in 15 mL)
Guaifenesin(200 mg in 15 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VICKS FORMULA 44DM COUGH and CHEST CONGESTION

Product Details

NDC Product Code
69423-810
Application Number
M012
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
April 9, 2025
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
Code: 9D2RTI9KYHClass: ACTIBQuantity: 10 mg in 15 mL
Code: 495W7451VQClass: ACTIBQuantity: 200 mg in 15 mL
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