Home NDC 85424-021 RoyceDerm Anti-Fungal Cream
Product NDC 85424-021
11-digit product format 854240021
Labeler code 85424
Product ID 85424-021_4e861073-88e9-b2f7-e063-6394a90ab94a
Type HUMAN OTC DRUG
Nonproprietary name Miconazole nitrate 2%
Dosage form CREAM
Route TOPICAL
Labeler RoyceDerm LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-24
Substance MICONAZOLE NITRATE
Active strength 2 g/100g
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 RoyceDerm Anti-Fungal Cream
Listing expiration 2027-12-31 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 998483 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 85424-021-01 RoyceDerm Anti-Fungal Cream 100 g in 1 CARTON CREAM 100 1
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 85424-021-01 85424002101 100 g in 1 CARTON (85424-021-01) 100 g 2026-04-24 No No Current