Home NDC 0316-0225 Desenex
Product NDC 0316-0225
11-digit product format 003160225
Labeler code 0316
Product ID 0316-0225_4833f384-eb1d-0049-e063-6394a90a9f53
Type HUMAN OTC DRUG
Nonproprietary name MICONAZOLE NITRATE
Dosage form POWDER
Route TOPICAL
Labeler Crown Laboratories
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-19
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0316-0225-30 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0316-0225-15 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0316-0225-30 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0316-0225-15 f5e01cc5f278…a2eaf40c39c3…
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
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 998461 Internal RxNorm lookup 998465 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 0316-0225-01 Desenex 43 g in 1 BOTTLE, PLASTIC POWDER 43 4 0316-0225-02 Desenex 85 g in 1 BOTTLE, PLASTIC POWDER 85 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0225 DESENEX (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES] 10 Current NDC, Legacy NDC 20231216_7c4a483e-199a-7ee1-e053-2a91aa0a3dec.zip 0316-0225 DESENEX (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES] 2 Current NDC, Legacy NDC, 2 package rows 20231111_09964187-12f1-bbe6-e063-6394a90acba0.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 8 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 Marketing end Sample Exclude flag Status 0316-0225-01 00316022501 43 g in 1 BOTTLE, PLASTIC (0316-0225-01) 43 g 2023-10-19 No No Current 0316-0225-02 00316022502 85 g in 1 BOTTLE, PLASTIC (0316-0225-02) 85 g 2023-10-19 No No Current 0316-0225-15 00316022515 43 g in 1 CONTAINER (0316-0225-15) 43 g 2018-12-01 0000-00-00 No No Current 0316-0225-30 00316022530 85 g in 1 CONTAINER (0316-0225-30) 85 g 2018-12-01 0000-00-00 No No Current