FDA.reportPublic FDA data

Initial Treatonic FUNGAL NAIL RENEWAL PATCHES

Product NDC
85569-013
11-digit product format
855690013
Labeler code
85569
Product ID
85569-013_55b688c2-20f0-65fa-e063-6294a90afe1c
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1%
Dosage form
PATCH
Route
TOPICAL
Labeler
100 KARMA INC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-18
Substance
TOLNAFTATE
Active strength
1 mg/1001
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
Initial Treatonic FUNGAL NAIL RENEWAL PATCHES
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 mg/1001

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
2677690Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48e377b4-abb1-34cf-e063-6294a90a2ea3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85569-013-01Initial Treatonic FUNGAL NAIL RENEWAL PATCHES32 in 1 PATCHPATCH322

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 38 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd67d1d65a-71d4-41fc-a71c-85a28ce6de0c2025-06-18WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd640df217-6982-441e-835a-dbe2031e732b2025-06-18WarningsExact identifier
application number: M005
EYELID WIPESEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD377fb842-aa78-ab2a-e063-6394a90a69f92025-06-13WarningsExact identifier
application number: M005
Lunavia Antifungal Foot BalmZINC UNDECYLENATE 10%XF Agencija Limited466f3285-9800-4219-902f-b78a713b952f2025-06-13WarningsExact identifier
application number: M005
Foot Cure Antifungal Foot BalmZINC UNDECYLENATESansar LLCac6075bf-cc1d-4e8a-aa13-5a85e80f34ee2025-06-13WarningsExact identifier
application number: M005
Lunavia AntifungalUNDECYLENIC ACID 25%XF Agencija Limited55891d2f-e2b8-4d9f-8140-dc258926ed902025-06-13WarningsExact identifier
application number: M005
TEGASOLVE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Zhengzhou Hangrui Network Technology Co., Ltd.375b0515-1b1f-23b8-e063-6294a90a9d682025-06-12WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREECVS Pharmacy979ab1d2-f184-455d-b31a-2ff2bd4592b82025-06-12WarningsExact identifier
application number: M005
Gemachlich ZuHause Fungal Nail RevitalizerGEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZERGuangdong Quadrant Ecological Technology Co., Ltd.37332cdf-7171-42cc-e063-6394a90a0fcf2025-06-10WarningsExact identifier
application number: M005
Eyelid WipesEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD36ddfa37-3913-9e48-e063-6294a90ae1be2025-06-08WarningsExact identifier
application number: M005
Everywhere Flushable WipesEVERYWHERE FLUSHABLE WIPESShenzhen Shierjie Biological Engineering Co., LTD371be299-5aaf-b9d7-e063-6294a90a87f52025-06-08WarningsExact identifier
application number: M005
Fungus MasterMICONAZOLE NITRATEClinical Resolution Laboratory, Inc.36eb334e-246b-249f-e063-6294a90ab8112025-06-06WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC8d725a50-fbe4-4a48-9cbf-f8b5c12dd6472025-06-03WarningsExact identifier
application number: M005
CharmTex Lightly Scented AntibacterialBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd1c9f4bff-3f6f-4498-b8a2-7d7f49d6ad2d2025-06-01WarningsExact identifier
application number: M005
DermaD ANTIFUNGAL TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.b97684ae-79d0-4208-b480-67794596ece72025-05-29WarningsExact identifier
application number: M005
Fungazol Athlete FootMICONAZOLE NITRATERida LLCce60e1ec-a69b-4b98-a2b2-105e9cd37bc72025-05-28WarningsExact identifier
application number: M005
Antifungal Boday WashTOLNAFTATECAVTECH HOLDING LLC3619d717-fe42-412f-e063-6394a90a03842025-05-27WarningsExact identifier
application number: M005
Toenail Fungus LiquidTOENAIL FUNGUS LIQUIDShenzhen Earth Surface Trading Co., Ltd.361f4c5c-7fa7-0440-e063-6294a90aad9f2025-05-27WarningsExact identifier
application number: M005
help it AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b22f423-eb11-445f-a484-9326c1fe3ad52025-05-27WarningsExact identifier
application number: M005
Seacall Hydrocortisone Ointment.SEACALL HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3616980a-03dc-deba-e063-6394a90a6ce72025-05-26WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677690tolnaftate 1 % Medicated PatchPSN48e377b4-abb1-34cf-e063-6294a90a2ea32
2677690tolnaftate 0.01 MG/MG Medicated PatchSCD48e377b4-abb1-34cf-e063-6294a90a2ea32
2677690tolnaftate 1 % Medicated PatchSY48e377b4-abb1-34cf-e063-6294a90a2ea32
2677690tolnaftate 1 % Medicated PatchPSN4c197131-9ca8-6024-e063-6294a90aa9cb1
1362039undecylenic acid 25 % Topical GelPSN4c197131-9ca8-6024-e063-6294a90aa9cb1
2677690tolnaftate 0.01 MG/MG Medicated PatchSCD4c197131-9ca8-6024-e063-6294a90aa9cb1
1362039undecylenic acid 0.25 MG/MG Topical GelSCD4c197131-9ca8-6024-e063-6294a90aa9cb1
2677690tolnaftate 1 % Medicated PatchSY4c197131-9ca8-6024-e063-6294a90aa9cb1
1362039undecylenic acid 25 % Topical GelSY4c197131-9ca8-6024-e063-6294a90aa9cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85569-013-018556900130132 PATCH in 1 PATCH (85569-013-01) 32 patch2026-02-18NoNoCurrent