Home NDC 21922-095 Antifungal Cream
Product NDC 21922-095
11-digit product format 219220095
Labeler code 21922
Product ID 21922-095_7d6e5fac-1b6c-49df-8a84-7702c4821c31
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-06
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 Antifungal Cream
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 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 21922-095-06 Antifungal Cream 1 in 1 CARTON CREAM 1 2 21922-095-06 Antifungal Cream 42.5 g in 1 TUBE CREAM 42.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-095 ANTIFUNGAL CREAM (MICONAZOLE NITRATE) CREAM [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, 2 package rows 20250424_8be4bbfa-424c-4ccf-b8bc-65b16c126053.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 21922-095-06 21922009506 1 TUBE in 1 CARTON (21922-095-06) / 42.5 g in 1 TUBE 1 tube 2025-03-06 No No Current