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 firm2026-10-15

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 6 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c93390-ee07-4f78-e063-6394a90add422026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kitPSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56cb7085-87d8-4273-e063-6394a90ac5df2026-07-17WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT CARETOLNAFTATE 1% ANTIFUNGAL FOOT CAREWenzhou Yuyuan Pharmaceutical Co., Ltd.56b10492-894c-33e1-e063-6394a90a8c0f2026-07-17WarningsExact identifier
application number: M005
Foot Choice-Nail Fungal PenUNDECYLENIC ACIDFoot Choice LLC4b0036a6-8751-4f44-b6b1-5be57fa92cdc2026-07-17WarningsExact identifier
application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream2% MICONAZOLE NITRATE ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56b54359-db21-b8b4-e063-6394a90a6f8c2026-07-16WarningsExact identifier
application number: M005
DRAVYNOR BALANITIS RELIEF CreamMICONAZOLE NITRATE 2% BALANITIS RELIEF CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.56b76a52-0743-4fe6-e063-6294a90a98a82026-07-16WarningsExact identifier
application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream5% BENZOYL PEROXIDE FOLLICULITIS CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56c558fa-303f-fc52-e063-6394a90a72f02026-07-16WarningsExact identifier
application number: M005
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsExact identifier
application number: M005
Medi-First Antifungal Cream Miconazole CreamMICONAZOLEUnifirst First Aid Corporation56a51b75-9c23-bcd2-e063-6394a90a9b122026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Tinea TreatmentCLEAR ROOT LABS TINEA TREATMENTAidance Scientic Inc., DBA Aidance Skincare & Topicals56a67bad-c677-d3b7-e063-6394a90ad2052026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Antifungal TreatmentCLEAR ROOT LABS ANTIFUNGAL TREATMENTAidance Scientific, Inc., DBA Aidance Skincare & Topicals5696bf23-230a-5f37-e063-6294a90a74132026-07-15WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL NAIL LiquidTOLNAFTATE 1% ANTIFUNGAL NAIL LIQUIDJiangxi Yudexi Pharmaceutical Co., LTD56b17e50-bff1-5eb0-e063-6294a90a3c082026-07-15WarningsExact identifier
application number: M005
terrasil Antifungal Cleansing BarCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions10a4fde0-87e1-4474-bcb5-255b0a7f1ecb2026-07-14WarningsExact identifier
application number: M005
OAKDOLCHE Tea Tree Oil AntifungalTOLNAFTATENanjing Qiaotun Technology Co., Ltd.569dee15-e68d-220e-e063-6294a90af7c52026-07-14WarningsExact identifier
application number: M005
Kimtara Nail Fungus TreatmentKIMTARA NAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5678e260-10c4-f203-e063-6294a90a62232026-07-13WarningsExact identifier
application number: M005
Aiilo NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.5689ac31-4d23-0fcc-e063-6394a90ac75b2026-07-13Exact identifier
application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.56519b25-f3c8-bcac-e063-6394a90af8792026-07-11WarningsExact identifier
application number: M005
Joymeey FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5652a22e-7b43-3c31-e063-6294a90ae4f12026-07-11WarningsExact identifier
application number: M005
iBeaLee Nail Repair PenIBEALEE NAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.564dc711-7fe2-7a8d-e063-6294a90aac262026-07-10WarningsExact 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