vagisil brand vagistat
Combe Incorporated Vagistat Drug Facts
Approved
Approval ID
833a5e4d-0591-4300-8f9c-fd00ffaf6041
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 15, 2025
Manufacturers
FDA
Combe Incorporated
DUNS: 002406502
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miconazole nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11509-0825
Application NumberANDA074760
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miconazole nitrate
Product Specifications
Route of AdministrationVAGINAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (8)
MICONAZOLE NITRATEActive
Quantity: 2 g in 100 g
Code: VW4H1CYW1K
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEGOXOL 7 STEARATEInactive
Code: 3EW5AXE5X5
Classification: IACT
PEG-5 OLEATEInactive
Code: 0240V77G50
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/15/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 12/23/2019
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 10/20/2020
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 12/23/2019
WARNINGS SECTION
LOINC: 34071-1Updated: 4/15/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 10/20/2020
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 10/20/2020
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 12/23/2019
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 10/20/2020
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/15/2025