Home NDC 64412-2010 Antifungal 1% Clotrimazole Cream
Product NDC 64412-2010
11-digit product format 644122010
Labeler code 64412
Product ID 64412-2010_53d444a1-2769-6f88-e063-6294a90a9729
Type HUMAN OTC DRUG
Nonproprietary name Antifungal 1% Clotrimazole Cream
Dosage form CREAM
Route TOPICAL
Labeler Twincraft Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-01
Substance CLOTRIMAZOLE
Active strength 1 g/100mL
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 Antifungal 1% Clotrimazole Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 1 g/100mL
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 64412-2010-1 Antifungal 1% Clotrimazole Cream 1 in 1 CARTON CREAM 1 3 64412-2010-1 Antifungal 1% Clotrimazole Cream 29.5 mL in 1 TUBE CREAM 29.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64412-2010 ANTIFUNGAL 1% CLOTRIMAZOLE CREAM CREAM [TWINCRAFT INC.] 1 Current NDC, 2 package rows 20241218_29698d9e-8449-ceee-e063-6394a90a366e.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 64412-2010-1 64412201001 1 TUBE in 1 CARTON (64412-2010-1) / 29.5 mL in 1 TUBE 1 tube 2024-10-01 No No Current