Home NDC 52389-733 Fungicure Liquid Gel
Product NDC 52389-733
11-digit product format 523890733
Labeler code 52389
Product ID 52389-733_41ae836c-6a1d-e223-e063-6394a90ae05a
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form GEL
Route TOPICAL
Labeler Kobayashi Healthcare International, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-12-31
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 Fungicure Liquid Gel
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 1049535 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 52389-733-09 Fungicure Liquid Gel 1 in 1 BOX GEL 1 9 52389-733-09 Fungicure Liquid Gel 9 g in 1 TUBE, WITH APPLICATOR GEL 9 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-733 FUNGICURE LIQUID GEL (CLOTRIMAZOLE) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240509_dfd03852-29bd-4e16-97f3-64dfde5f8ff8.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 Marketing start Marketing end Sample Exclude flag Status 52389-733-09 52389073309 1 TUBE, WITH APPLICATOR in 1 BOX (52389-733-09) / 9 g in 1 TUBE, WITH APPLICATOR 2016-01-04 0000-00-00 No No Current