Home NDC 21922-094 ANTIFUNGAL
Product NDC 21922-094
11-digit product format 219220094
Labeler code 21922
Product ID 21922-094_c9cf3a99-2b28-49c8-85f9-f693ca847074
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-06
Substance CLOTRIMAZOLE
Active strength 10 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 ANTIFUNGAL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309367 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 21922-094-04 ANTIFUNGAL 1 in 1 CARTON CREAM 1 2 21922-094-04 ANTIFUNGAL 14 g in 1 TUBE CREAM 14 2 21922-094-05 ANTIFUNGAL 1 in 1 CARTON CREAM 1 2 21922-094-05 ANTIFUNGAL 28 g in 1 TUBE CREAM 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-094 ANTIFUNGAL (CLOTRIMAZOLE) CREAM [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, 4 package rows 20250308_afbc28f8-bb76-424d-9d73-136e6c283ead.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 36 of 49 · 969 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 21922-094-04 21922009404 1 TUBE in 1 CARTON (21922-094-04) / 14 g in 1 TUBE 1 tube 2025-03-06 No No Current 21922-094-05 21922009405 1 TUBE in 1 CARTON (21922-094-05) / 28 g in 1 TUBE 1 tube 2025-03-06 No No Current