ANTIFUNGAL
Approved
Approval ID
33d9c724-d4c4-2597-e063-6294a90aa5f3
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.
MICONAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84722-3060
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
MICONAZOLE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (11)
MICONAZOLEActive
Quantity: 2 g in 100 g
Code: 7NNO0D7S5M
Classification: ACTIB
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
IMIDAZOLIDINYL UREAInactive
Code: M629807ATL
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
CETEARETH-20Inactive
Code: YRC528SWUY
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
SODIUM CETEARYL SULFATEInactive
Code: 7ZBS06BH4B
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT