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VICKS FORMULA 44DM

VICKS FORMULA 44™DM COUGH & CHEST CONGESTION

Approved
Approval ID

05412b91-c1f0-c947-e063-6294a90acd17

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 9, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

Products 1

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

Dextromethorphan HBr, Guaifenesin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69423-810
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dextromethorphan HBr, Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification

INGREDIENTS (14)

SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 15 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 200 mg in 15 mL
Code: 495W7451VQ
Classification: ACTIB

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VICKS FORMULA 44DM - FDA Drug Approval Details