Home NDC 52389-600 Fungicure
Product NDC 52389-600
11-digit product format 523890600
Labeler code 52389
Product ID 52389-600_51def52b-eaf3-ed93-e063-6294a90ac924
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form LIQUID
Route TOPICAL
Labeler Kobayashi Healthcare International, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-06-05
Substance CLOTRIMAZOLE
Active strength 10 mg/mL
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 Fungicure
Brand name suffix Intensive
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309370 Internal RxNorm lookup 1045620 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 52389-600-60 FungicureIntensive 1 in 1 BOX LIQUID 1 12 52389-600-60 FungicureIntensive 60 mL in 1 BOTTLE, SPRAY LIQUID 60 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-600 FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241101_1f1b413f-278e-434f-8590-4cf731663f5c.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 · 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 52389-600-60 52389060060 1 BOTTLE, SPRAY in 1 BOX (52389-600-60) / 60 mL in 1 BOTTLE, SPRAY 2008-06-05 0000-00-00 No No Current