FDA.reportPublic FDA data

TOENAIL FUNGUS TREATMENT

Product NDC
85569-005
11-digit product format
855690005
Labeler code
85569
Product ID
85569-005_55b676ed-e1d8-1700-e063-6394a90a6ec3
Type
HUMAN OTC DRUG
Nonproprietary name
25% Undecylenic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
100 KARMA INC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-31
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
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
TOENAIL FUNGUS TREATMENT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bb000dc-5e6c-b43b-e063-6394a90a63a9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85569-005-01TOENAIL FUNGUS TREATMENT30 mL in 1 CARTONLIQUID302

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 14 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier
application number: M005
TolfyraTOLNAFTATEOncora Pharma, LLCb28ee9f2-fc45-4336-b374-be7aa51d44e92026-05-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd5148b838-d26e-cf66-e063-6394a90ae4692026-05-09WarningsExact identifier
application number: M005
HuiPoLii NAIL PFLASTERTOLNAFTATE 1% NAIL PFLASTERJiangxi Yudexi Pharmaceutical Co., LTD514b1c2d-cecb-30a2-e063-6394a90af2662026-05-08WarningsExact identifier
application number: M005
Recuren Plus Jock Itch CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD450dab4d-168a-60b8-e063-6394a90ab3032026-05-08WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.51465ebf-3b5f-e2bf-e063-6394a90adaf22026-05-07WarningsExact identifier
application number: M005
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
application number: M005
QQE Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.510ff705-e2cb-b77b-e063-6394a90a9e722026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEAkron Pharma Inc692d7e0f-50d4-4abb-8c74-36bc98064fe72026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEKJD Pharma Private Limited5115f8e3-5668-5207-e063-6394a90a76502026-05-05WarningsExact identifier
application number: M005
NATURAL CURES FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD510a8df7-ea6d-d634-e063-6294a90aea532026-05-04WarningsExact identifier
application number: M005
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsExact identifier
application number: M005
Uauko Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.50d16854-ab90-d6cf-e063-6294a90a21b12026-05-02WarningsExact identifier
application number: M005
NAIL RENEWTOLNAFTATENailrenew Corpa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b52026-05-02WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZER SPRAYCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4934c20d-6295-aeb8-e063-6394a90adfeb2026-04-30WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4931f2e4-0fef-a8c7-e063-6394a90ac16e2026-04-30WarningsExact identifier
application number: M005
MINADCIN TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD50a9264e-aba0-0ae2-e063-6294a90acfff2026-04-30WarningsExact identifier
application number: M005
ANTIFUNGALUNDECYLENIC ACIDChemco Corporation50893584-c1c6-9ffa-e063-6394a90ae1772026-04-29WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.50949ae2-3ebe-08d2-e063-6394a90a20462026-04-29WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677690tolnaftate 1 % Medicated PatchPSN3d4bbc65-955f-8fd8-e063-6294a90adc442
998329undecylenic acid 25 % Topical SolutionPSN3bb000dc-5e6c-b43b-e063-6394a90a63a92
998329undecylenic acid 25 % Topical SolutionPSN3d4bbc65-955f-8fd8-e063-6294a90adc442
2677690tolnaftate 0.01 MG/MG Medicated PatchSCD3d4bbc65-955f-8fd8-e063-6294a90adc442
998329undecylenic acid 250 MG/ML Topical SolutionSCD3bb000dc-5e6c-b43b-e063-6394a90a63a92
998329undecylenic acid 250 MG/ML Topical SolutionSCD3d4bbc65-955f-8fd8-e063-6294a90adc442
2677690tolnaftate 1 % Medicated PatchSY3d4bbc65-955f-8fd8-e063-6294a90adc442
998329undecylenic acid 25 % Topical SolutionSY3bb000dc-5e6c-b43b-e063-6394a90a63a92
998329undecylenic acid 25 % Topical SolutionSY3d4bbc65-955f-8fd8-e063-6294a90adc442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85569-005-018556900050130 mL in 1 CARTON (85569-005-01) 30 ml2025-08-31NoNoCurrent