FDA.reportPublic FDA data

Hermon Athletes foot Tolnaftate 1% kit

Product NDC
85398-018
11-digit product format
853980018
Labeler code
85398
Product ID
85398-018_5567639e-1483-121e-e063-6294a90a2eae
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1% kit
Dosage form
KIT
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-31
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
Hermon Athletes foot Tolnaftate 1% kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103951Internal RxNorm lookup
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
4142f490-c4b5-a9f3-e063-6394a90ab75eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-007-02Hermon Athletes foot Tolnaftate 1% kit116 g in 1 CARTONSOAP1 g in 1161.16 g in 116g2
85398-017-02Hermon Athletes foot Tolnaftate 1% kit57 g in 1 TUBECREAM57 g0.57 g in 57g2
85398-018-01Hermon Athletes foot Tolnaftate 1% kit1 in 1 CARTONKIT12

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 5 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005
DERMFREE HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4d9361-3633-59b2-e063-6294a90aa3ea2026-07-21WarningsExact identifier
application number: M005
OURUI ONE FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a473f03-f4cc-74ef-e063-6394a90ac7072026-07-20WarningsExact identifier
application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)Jiangxi Yudexi Pharmaceutical Co., LTD51eb8766-cc94-360d-e063-6294a90a69532026-07-20WarningsExact identifier
application number: M005
TINGOLE FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD5272c6fa-75f7-c698-e063-6394a90ac81e2026-07-20WarningsExact identifier
application number: M005
Vamy ANTIFUNGALTOLNAFTATE 1% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4dfdf3a2-95a8-9176-e063-6294a90a64de2026-07-20WarningsExact identifier
application number: M005
Antifungal creamANTIFUNGAL CREAMShenzhen Earth Surface Trading Co., Ltd.5708cc16-9a26-fd3c-e063-6394a90ac0ee2026-07-20WarningsExact identifier
application number: M005
TrpWinner TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523c2a9c-3b35-bf73-e063-6394a90ae17d2026-07-20WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD4ac347b5-d21b-cc9a-e063-6394a90a54962026-07-20WarningsExact identifier
application number: M005
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGALCLOTRIMAZOLE 1% TINEA VERSICOLOR TREATMENT ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4ac31b1d-59d7-f45c-e063-6294a90a0d3d2026-07-20WarningsExact identifier
application number: M005
IraEvanes ANTIFUNGAL FOOTTOLNAFTATE 1% ANTIFUNGAL FOOTJiangxi Yudexi Pharmaceutical Co., LTD4d851a99-a453-e829-e063-6294a90a91182026-07-20WarningsExact identifier
application number: M005
LYSSERA Fungal Nail RenewalUNDECYLENIC ACID 25% ANTIFUNGAJiangxi Yudexi Pharmaceutical Co., LTD4dea6df4-e66b-c24a-e063-6294a90afca72026-07-20WarningsExact identifier
application number: M005
Kakalsa TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD5123c0c3-bba8-d61c-e063-6394a90aab702026-07-20WarningsExact identifier
application number: M005
SOVS FUNGAL NAIL REPAIR RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR RENEWALJiangxi Yudexi Pharmaceutical Co., LTD536b0c48-691e-755b-e063-6294a90a778e2026-07-20WarningsExact identifier
application number: M005
Tea Tree AntifungalCLOTRIMAZOLEHONG KONG UNORDERED TRADING CO., LIMITED56de35b7-b57d-1c62-e063-6294a90a757d2026-07-18WarningsExact identifier
application number: M005
ACTIV-CHARCOAL ANTIFUNGALTOLNAFTATEHONG KONG UNORDERED TRADING CO., LIMITED56def103-40ef-cd88-e063-6394a90a07172026-07-18WarningsExact identifier
application number: M005
SOVS MULTI-PURPOSE NAIL REPAIRTOLNAFTATE 1% MULTI-PURPOSE NAIL REPAIRWenzhou Yuyuan Pharmaceutical Co., Ltd.56df87a7-7fc2-5ba4-e063-6394a90a652b2026-07-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 1 % Topical CreamPSN4142f490-c4b5-a9f3-e063-6394a90ab75e2
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 10 MG/ML Topical CreamSCD4142f490-c4b5-a9f3-e063-6394a90ab75e2
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
85398-007-0285398000702116 g in 1 CARTON116 gHistorical
85398-017-028539800170257 g in 1 TUBE57 gHistorical
85398-018-01853980018011 KIT in 1 CARTON (85398-018-01) * 57 g in 1 TUBE (85398-017-02) * 116 g in 1 CARTON (85398-007-02) 1 kit2025-10-31NoNoCurrent