Home NDC 10135-720 Miconazole Nitrate Antifungal Powder
Product NDC 10135-720
11-digit product format 101350720
Labeler code 10135
Product ID 10135-720_441cab8b-3a58-00e0-e063-6294a90aaa23
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate Antifungal Powder
Dosage form POWDER
Route TOPICAL
Labeler Marlex Pharmaceuticals, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-01
Substance MICONAZOLE NITRATE
Active strength 2 g/100g
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 Miconazole Nitrate Antifungal Powder
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/100g
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 10135-720-85 Miconazole Nitrate Antifungal Powder 85 g in 1 BOTTLE POWDER 85 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-720 MICONAZOLE NITRATE ANTIFUNGAL POWDER POWDER [MARLEX PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241016_de4f703c-39e9-855e-e053-2a95a90a6ea9.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 40 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 10135-720-85 10135072085 85 g in 1 BOTTLE (10135-720-85) 85 g 2022-05-01 0000-00-00 No No Current