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 12 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athletes FootMICONAZOLE NITRATEPremier Brands of America Inc52d0909a-f404-0af4-e063-6394a90a3d0c2026-06-01WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd431483f6-2386-9f5c-e063-6294a90af1042026-06-01WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWalgreens Company3f8d45e1-54a2-a658-e063-6294a90a6cbb2026-06-01WarningsExact identifier
application number: M005
Remedy NailsUNDECYLENIC ACIDAdwill Labs Inc4e87b76c-c430-466a-bc30-fe1785c7c6602026-06-01WarningsExact identifier
application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)TOLNAFTATE1%Guangzhou Huixue Biotechnology Co., Ltd.52f1f654-fba3-e90e-e063-6394a90a1df42026-05-29WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC52da8be4-467c-c011-e063-6294a90a166f2026-05-28WarningsExact identifier
application number: M005
Terramed Just Think Comfort Jock Itch Antifungal TreatmentMICONAZOLE NITRATERida LLC2acb9027-8f20-4b77-9b45-17fe11622c7c2026-05-27WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL TEA TREETOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd52b3b0df-3f62-f9bc-e063-6394a90a52b32026-05-26WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b51877-e04c-569e-e063-6394a90a2fc92026-05-26WarningsExact identifier
application number: M005
NAIL EXTRA STRENGTH REPAIR PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6208d-53e4-eaa0-e063-6394a90abe7a2026-05-26WarningsExact identifier
application number: M005
Toenail Fungus Pen PreventativeUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6766f-948b-2602-e063-6294a90a03cf2026-05-26WarningsExact identifier
application number: M005
KDMANTOLNAFTATEDongguan Youmi Trading Co., Ltd52a4e836-2059-a49f-e063-6394a90a65562026-05-25WarningsExact identifier
application number: M005
PUTRIZENUNDECYLENIC ACID, TOLNAFTATEGuangzhou Lianbiquan Biological Technology co., Ltd52a58f24-2a11-4d34-e063-6394a90a29242026-05-25WarningsExact identifier
application number: M005
Eye CareSprayEYELID CLEANSING SPRAYShenzhen Shierjie Biological Engineering Co., LTD52aef5dd-ff33-cace-e063-6294a90a415a2026-05-25WarningsExact identifier
application number: M005
Saviland PRO Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD5250003a-8d3a-818b-e063-6294a90aa6592026-05-21WarningsExact identifier
application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52506297-44d7-b2a7-e063-6394a90a0a3c2026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52512e7e-5e28-4383-e063-6294a90a448a2026-05-21WarningsExact identifier
application number: M005
Vrenmol Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52516861-e386-d0cb-e063-6394a90a17d02026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Toenail Renewal SolutionTOLNAFTATE,UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52519110-a3c9-21da-e063-6294a90abbce2026-05-21WarningsExact identifier
application number: M005
Fungal Nail Repair PenUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd523c32f7-b803-bf79-e063-6394a90aad5a2026-05-20WarningsExact 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