Home NDC 52389-298 Fungicure Anti-Fungal Liquid
Product NDC 52389-298
11-digit product format 523890298
Labeler code 52389
Product ID 52389-298_4e67ab01-b191-35e8-e063-6294a90a51df
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form LIQUID
Route TOPICAL
Labeler Kobayashi Healthcare International, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-13
Substance TOLNAFTATE
Active strength 8.65 mg/mL
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 Anti-Fungal Liquid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 8.65 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52389-298-30 Fungicure Anti-Fungal Liquid 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 30 9 52389-298-30 Fungicure Anti-Fungal Liquid 1 in 1 BOX LIQUID 1 9 52389-298-40 Fungicure Anti-Fungal Liquid 40 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 40 9 52389-298-40 Fungicure Anti-Fungal Liquid 1 in 1 BOX LIQUID 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-298 FUNGICURE ANTI-FUNGAL LIQUID (TOLNAFTATE) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20250412_b18ee199-0659-733c-e053-2a95a90ab6b5.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52389-298-30 52389029830 1 BOTTLE, WITH APPLICATOR in 1 BOX (52389-298-30) / 30 mL in 1 BOTTLE, WITH APPLICATOR 2020-10-13 0000-00-00 No No Current 52389-298-40 52389029840 1 BOTTLE, WITH APPLICATOR in 1 BOX (52389-298-40) > 40 mL in 1 BOTTLE, WITH APPLICATOR 2021-04-05 0000-00-00 No No Current