Home NDC 0316-0255 Desenex Antifungal Foot Cream
Product NDC 0316-0255
11-digit product format 003160255
Labeler code 0316
Product ID 0316-0255_48346f3b-72c9-a271-e063-6394a90a9238
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Crown Laboratories, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-01
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Desenex Antifungal Foot Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998483 Internal RxNorm lookup 2709228 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0316-0255-01 Desenex Antifungal Foot Cream 1 in 1 CARTON CREAM 1 2 0316-0255-01 Desenex Antifungal Foot Cream 28 g in 1 TUBE CREAM 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0255 DESENEX ANTIFUNGAL FOOT CREAM (MICONAZOLE NITRATE) CREAM [CROWN LABORATORIES, INC.] 1 Current NDC, 2 package rows 20250326_311abb56-e176-0510-e063-6294a90a97f5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 36 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0316-0255-01 00316025501 1 TUBE in 1 CARTON (0316-0255-01) / 28 g in 1 TUBE 1 tube 2025-03-01 No No Current