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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52389-29852389-298-40DDiscontinued by firm2026-10-20

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
IngredientStrength
TOLNAFTATE8.65 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b18ee199-0659-733c-e053-2a95a90ab6b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-298-30Fungicure Anti-Fungal Liquid30 mL in 1 BOTTLE, WITH APPLICATORLIQUID309
52389-298-30Fungicure Anti-Fungal Liquid1 in 1 BOXLIQUID19
52389-298-40Fungicure Anti-Fungal Liquid40 mL in 1 BOTTLE, WITH APPLICATORLIQUID409
52389-298-40Fungicure Anti-Fungal Liquid1 in 1 BOXLIQUID19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-298FUNGICURE ANTI-FUNGAL LIQUID (TOLNAFTATE) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]6Current NDC, Legacy NDC, 4 package rows20250412_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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
application number: M005
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
application number: M005
UKVOA Toenail Fungus TreatmentTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2e3cde7b-850e-f9d2-e063-6394a90adb182025-02-16WarningsExact identifier
application number: M005
UKOVA FOOT ODOR PROBIOTICTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2de0225d-dd85-e2da-e063-6294a90a050b2025-02-11WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes Foot WipesTOLNAFTATECosco International, Inc.cde656a9-7841-4a73-a2f4-f5a76a3e15c12025-02-06WarningsExact identifier
application number: M005
Silka Athletes FootMICONAZOLE NITRATEGenomma Lab USA307104a2-2df6-43b0-bf3f-f4d93d3e40f12025-02-05WarningsExact identifier
application number: M005
MICONAZOLE NitrateMICONAZOLE NITRATENuCare Pharmaceuticals,Inc.fd7dd2eb-03a7-ef1f-e053-6294a90a85572025-02-04WarningsExact identifier
application number: M005
Molecular AFTOLNAFTATERenu Laboratories, LLC1b47e687-29cf-48ce-8bc3-ac8f44f05baa2025-02-03WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Papalo Group LLC2d2c0e12-123d-75bd-e063-6394a90ae5462025-01-31WarningsExact identifier
application number: M005
70% Isopropyl AlcoholISOPROPYL ALCOHOLIDO PHARMd5833c6f-81dd-6ff6-e053-2995a90ac76d2025-01-30WarningsExact identifier
application number: M005
AWAS ALCOHOLSPRAYALCOHOLIDO PHARM03010837-0289-3e08-e063-6394a90a7d042025-01-30WarningsExact identifier
application number: M005
ELON Dual Defense Anti Fungal FormulaUNDECYLENIC ACIDLittle Giant Holdings LLC45c4567d-7876-6459-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M005
DCH Labs Antifungal JockMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCfc749882-2e1e-cad3-e053-6294a90a33ca2025-01-27WarningsExact identifier
application number: M005
Antifungal PenUNDECYLENIC ACID 25%XF Agencija Limiteda15d4512-0fc6-424f-9dd3-ab433d9b7a262025-01-27WarningsExact identifier
application number: M005
Mata HongosUNDECYLENIC ACIDVitamex USA, Corp21ca7edb-dde3-5846-e063-6394a90a3cc02025-01-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd53cb4c0d-40b5-4cf3-b122-fd6dd654883f2025-01-23WarningsExact identifier
application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGALTOLNAFTATENatureplex, LLC575b8645-9166-4242-a74f-f4aa4acaaf3d2025-01-15WarningsExact identifier
application number: M005
Tobcharm Antifungal Treatment CreamANTIFUNGAL TREATMENT CREAMGuangzhou Zanming Trading Co., Ltd.2ba241cc-2767-1190-e063-6294a90ac66b2025-01-13WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2%MICONAZOLE NITRATEAkron Pharma Inc.8933f939-098a-4257-8d9c-4d5c3240e9a62025-01-10WarningsExact identifier
application number: M005
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52389-298-30523890298301 BOTTLE, WITH APPLICATOR in 1 BOX (52389-298-30) / 30 mL in 1 BOTTLE, WITH APPLICATOR2020-10-130000-00-00NoNoCurrent
52389-298-40523890298401 BOTTLE, WITH APPLICATOR in 1 BOX (52389-298-40) > 40 mL in 1 BOTTLE, WITH APPLICATOR2021-04-050000-00-00NoNoCurrent