ANTIFUNGAL
Approved
Approval ID
33db98f5-f6d9-742a-e063-6394a90a2a03
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
VIVE HEALTH LLC
DUNS: 047025993
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CLOTRIMAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84722-3059
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
CLOTRIMAZOLE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (6)
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 1 g in 100 g
Code: G07GZ97H65
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT