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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
application number: M005
Ever Ready HAND SANITIZERETHYL ALCOHOLEver Ready First Aidec1af7ef-3c95-9c60-e053-2a95a90acf472024-01-15WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLSled Distribution, LLCe7451738-75d5-5dc4-e053-2a95a90a7aee2024-01-15WarningsExact identifier
application number: M005
Medical SuperALCOHOLBeijing HKKY Medical Tech. Co., Ltd.ed2649c6-d971-4338-8745-cd0a40f7b0c22024-01-13WarningsExact identifier
application number: M005
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with MentholTOLNAFTATEScholl's Wellness Companydad00745-e411-35b8-e053-2a95a90a10002023-12-21WarningsExact identifier
application number: M005
TINEACIDETOLNAFTATEBlaine Labs Inc.273eb424-5dc3-40c8-9ea7-2f732cbd11c92023-12-21WarningsExact identifier
application number: M005
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
application number: M005
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
application number: M005
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.be92b480-56e8-4371-adbc-40fe74f6747c2023-12-01WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact 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