Home NDC 36800-613 Anti-Fungal Powder
Product NDC 36800-613
11-digit product format 368000613
Labeler code 36800
Product ID 36800-613_42f4c03f-a3fe-ff3f-e063-6294a90a72df
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form POWDER
Route TOPICAL
Labeler TopCo Associates
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-03
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
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 Anti-Fungal Powder
Listing expiration 2026-12-31 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 · 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 36800-613-01 Anti-Fungal Powder 71 g in 1 BOTTLE, PLASTIC POWDER 71 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-613 ANTI-FUNGAL POWDER (MICONAZOLE NITRATE) POWDER [TOPCO ASSOCIATES] 2 Current NDC, 1 package rows 20241109_19c3fbc5-abde-57df-e063-6394a90a125c.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 Sample Exclude flag Status 36800-613-01 36800061301 71 g in 1 BOTTLE, PLASTIC (36800-613-01) 71 g 2024-06-03 No No Current