FDA.reportPublic FDA data

Hermon Antifungal Soap.

Product NDC
85398-019
11-digit product format
853980019
Labeler code
85398
Product ID
85398-019_489769b9-6479-2174-e063-6294a90ae038
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate 1%
Dosage form
SOAP
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-07
Substance
TOLNAFTATE
Active strength
10 mg/g
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 packagepackage85398-01985398-019-01DDiscontinued by firm2026-10-12

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
Hermon Antifungal Soap.
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1807715Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41e37014-549c-e592-e063-6294a90ac6abAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-019-01Hermon Antifungal Soap.232 g in 1 CARTONSOAP2322
85398-019-02Hermon Antifungal Soap.226 g in 1 CARTONSOAP2262

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 27 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Myco Nail A Antifungal SolutionUNDECYLENIC ACIDKramer Novis550358d7-69e8-4ea3-bcf9-d647c457287d2025-12-04WarningsExact identifier
application number: M005
Tea Tree Oil Antifungal SoapsTOLNAFTATENanjing Jitaxing Technology Co., LTD4517d3a7-9144-b91d-e063-6294a90a49902025-12-03WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions23ca78c0-16a9-455c-99a7-b9a9a3affa602025-12-03WarningsExact identifier
application number: M005
Gembooxt Nail Fungus SolutionGEMBOOXT NAIL FUNGUS SOLUTIONGuangdong Quadrant Ecological Technology Co., Ltd.44f5c1bc-decf-beef-e063-6394a90ab5622025-12-02WarningsExact identifier
application number: M005
WELMATE Clotrimazole Topical SolutionCLOTRIMAZOLEYYBA CORPdc5bac4a-938c-4678-89ac-a899440c6a3c2025-12-02WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALTOLNAFTATECARDINAL HEALTH 110 dba LEADERbb14825c-518d-bfba-e053-2995a90a78892025-12-02WarningsExact identifier
application number: M005
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d375325-ddad-f1e1-e063-6394a90a679f2025-12-01WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc0a6cb1f7-a2a2-46a2-ae63-d205318996f02025-12-01WarningsExact identifier
application number: M005
CAREALL Miconazole NitrateMICONAZOLE NITRATENew World Imports, Incbed775be-8bcb-44c2-9b9f-8bb25b4b24532025-12-01WarningsExact identifier
application number: M005
CAREALL TolnaftateTOLNAFTATENew World Imports, Inccabf84c1-1500-46fe-b226-b16d4a0666c72025-12-01WarningsExact identifier
application number: M005
TrimazoleCLOTRIMAZOLETrifluent Pharma LLCa3bafc52-1404-4e0b-84c1-e28bffcb091e2025-12-01WarningsExact identifier
application number: M005
APUREE Pure Nailtific Extra-Strength Fungal Nail PatchesAPUREE PURE NAILTIFIC EXTRA-STRENGTH FUNGAL NAIL PATCHESGuangzhou Meixi Biotechnology Co., Ltd.445354d8-bec2-0fd9-e063-6394a90a00992025-11-24WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEVALU MERCHANDISERS, COf4abb499-6893-9efb-e053-2995a90a33ed2025-11-24WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE ATHLETES FOOT POWDER SPRAY TALC FREEVALU MERCHANDISERS, CO9ac97d4a-169b-49ff-aa34-ccb5b43726a12025-11-24WarningsExact identifier
application number: M005
TolnafateFOOT ODOR CONTROL POWDER SPRAYVALU MERCHANDISERS, CO51b69b0f-d63f-4fe0-87e6-722f955687612025-11-24WarningsExact identifier
application number: M005
Miconazole Nitrate Antifungal PowderMICONAZOLE NITRATE ANTIFUNGAL POWDERMarlex Pharmaceuticals, Inc.de4f703c-39e9-855e-e053-2a95a90a6ea92025-11-21WarningsExact identifier
application number: M005
Odor-Eaters Athletes FootTOLNAFTATEBlistex Inc.20d795d1-2345-4d4f-8439-07ad11ff8f652025-11-21WarningsExact identifier
application number: M005
Derman AntifungalZINC UNDECYLENATECompania Internacional de Comercio, S.A.P.I de C.V.0129d801-90f6-49fd-857f-27d6ba9fc66c2025-11-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions9afb964c-9b88-4701-adcf-7070e25cb6c12025-11-19WarningsExact identifier
application number: M005
AU KAH CHUEN ANTIFUNGALCLOTRIMAZOLEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.3a262bcd-e6c0-4554-ab1c-9c861f90e1902025-11-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN41e37014-549c-e592-e063-6294a90ac6ab2
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD41e37014-549c-e592-e063-6294a90ac6ab2
1807715tolnaftate 1 % Medicated Bar SoapSY41e37014-549c-e592-e063-6294a90ac6ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-019-0185398001901232 g in 1 CARTON232 gHistorical
85398-019-0285398001902226 g in 1 CARTON (85398-019-02) 226 g2025-11-07NoNoCurrent