FDA.reportPublic FDA data

Athlete Foot Medicated bar

Product NDC
85398-007
11-digit product format
853980007
Labeler code
85398
Product ID
85398-007_41b1ce91-a894-bc8c-e063-6394a90a4b92
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOAP
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-18
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Athlete Foot Medicated bar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

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
3b2cedb2-18f4-f571-e063-6394a90a6418Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-007-01Athlete Foot Medicated bar232 g in 1 CARTONSOAP2322
85398-007-01Athlete Foot Treatment Kit232 g in 1 CARTONSOAP232 g1 g in 100g2
85398-007-02Athlete Foot Medicated bar116 g in 1 CARTONSOAP1162
85398-007-02Hermon Athletes foot Tolnaftate 1% kit116 g in 1 CARTONSOAP1 g in 1161.16 g in 116g2

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 31 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Antifungal LiquidTOLNAFTATEFSA Store Inc.fae36294-68b6-bf14-e053-6394a90aaacd2025-10-27WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.58dd955e-e68b-4fbd-90c8-a85b15c00dc72025-10-25WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.1360cdd8-b2b2-4af9-b6ff-af1101d49e182025-10-25WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYBetter Living Brands LLCccff8d63-ee7d-eada-e053-2995a90ac5dd2025-10-24WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYBetter Living Brands LLCccff4830-6d81-2a0d-e053-2a95a90a154c2025-10-24WarningsExact identifier
application number: M005
Liquid Antifungal TreatmentTOLNAFTATEHudson Health LLC14a9efd8-e49f-12fa-e063-6394a90aa8a02025-10-24WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsExact identifier
application number: M005
Signature Care Antifungal Cream Tolnaftate 1%TOLNAFTATEBETTER LIVING BRANDS LLCb02b81d6-8db4-927b-e053-2995a90a39582025-10-24WarningsExact identifier
application number: M005
Winco Foods TolnaftateTOLNAFTATEWinco Foods, LLC218f7613-1401-4f1b-bf46-576b536825af2025-10-23WarningsExact identifier
application number: M005
zourunan MULTI-PURPOS TREATMENTMULTI-PURPOS TREATMENTGuchutang Biotechnology (Longyan) Co., Ltd41bad254-b674-9521-e063-6294a90ab6342025-10-22WarningsExact identifier
application number: M005
zourunan FOOT ODOR PROBIOTICFOOT ODORGuchutang Biotechnology (Longyan) Co., Ltd41bbc02c-53f2-2d94-e063-6394a90ac9ec2025-10-22WarningsExact identifier
application number: M005
Signature Care Athletes FootCLOTRIMAZOLESafewayc1750c17-4afb-aecf-e053-2a95a90af35b2025-10-22WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEImperial Feet B.V.1189c7d8-7c8f-ae01-e063-6294a90ac2702025-10-21WarningsExact identifier
application number: M005
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
application number: M005
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
application number: M005
ndc (product): 85398-007
Athletes FootTOLNAFTATEQuantum, Inc.6cb95707-9831-41f1-a23e-9e3356141fdc2025-10-20WarningsExact identifier
application number: M005
Toe FungusTOLNAFTATEImperial Feet B.V.118a6c97-4e8a-050a-e063-6294a90a11082025-10-17WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangzhou Haishi Biological Technology Co., Ltd.4141574d-7a5b-c437-e063-6394a90aacb62025-10-16WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHY-VEE, INC415ecf9b-460d-82b6-e063-6294a90a0e052025-10-16WarningsExact identifier
application number: M005
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 1 % Medicated Bar SoapPSN3b2cedb2-18f4-f571-e063-6394a90a64182
1807715tolnaftate 1 % Medicated Bar SoapPSN3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 1 % Medicated Bar SoapPSN4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 1 % Topical CreamPSN4142f490-c4b5-a9f3-e063-6394a90ab75e2
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD3b2cedb2-18f4-f571-e063-6394a90a64182
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 10 MG/ML Topical CreamSCD4142f490-c4b5-a9f3-e063-6394a90ab75e2
992528terbinafine hydrochloride 1 % Topical CreamSY3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 1 % Medicated Bar SoapSY3b2cedb2-18f4-f571-e063-6394a90a64182
1807715tolnaftate 1 % Medicated Bar SoapSY3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 1 % Medicated Bar SoapSY4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 1 % Topical CreamSY4142f490-c4b5-a9f3-e063-6394a90ab75e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-007-0185398000701232 g in 1 CARTON (85398-007-01) 232 g2025-08-18NoNoCurrent
85398-007-0285398000702116 g in 1 CARTON (85398-007-02) 116 g2025-08-18NoNoCurrent