Home NDC 59088-442 Mycozyl AP
Product NDC 59088-442
11-digit product format 590880442
Labeler code 59088
Product ID 59088-442_237410ce-a7e8-47ec-e063-6394a90a89a2
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form POWDER
Route TOPICAL
Labeler PureTek Corporation
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-08
Substance MICONAZOLE NITRATE
Active strength 2 g/85g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 Mycozyl AP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/85g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998461 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 59088-442-07 Mycozyl AP 85 g in 1 BOTTLE POWDER 85 5 59088-442-07 Miconatate 85 g in 1 BOTTLE POWDER 1 g in 85 2 g in 85g 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-442 MYCOZYL AP (MICONAZOLE NITRATE) POWDER [PURETEK CORPORATION] 5 Current NDC, Legacy NDC, 1 package rows 20241004_b3c46a30-7ff2-0dc4-e053-2995a90aa571.zip 59088-442 MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION] 3 Current NDC, Legacy NDC 20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.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 59088-442-07 59088044207 85 g in 1 BOTTLE (59088-442-07) 85 g 2020-12-08 0000-00-00 No No Current