MedPath

Vicks VapoCool

VICKS VapoCOOL™ SEVERE MENTHOL • ORAL ANESTHETIC Drops

Approved
Approval ID

c77f8878-5eef-b006-e053-2a95a90a1866

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 30, 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.

Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69423-796
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2025
FDA Product Classification

INGREDIENTS (6)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MENTHOLActive
Quantity: 20 mg in 1 1
Code: L7T10EIP3A
Classification: ACTIB

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Vicks VapoCool - FDA Drug Approval Details