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 3 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
application number: M005
VXGXO antifungal with tea tree oilTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58fd67c5-c985-13a7-e063-6294a90a40fb2026-08-14WarningsExact identifier
application number: M005
Charmpoo ANTIFUNGAL BODY CreamMICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.58ff4779-83a7-afe2-e063-6294a90a9f9a2026-08-14WarningsExact identifier
application number: M005
TEATREEOILANTIFUNGALUNDECYLENIC ACID AND ZINC UNDECYLENATEFoshan Chancheng District Xuntou Electronic Commerce Co., Ltd5900904f-cf51-4398-e063-6394a90aca6c2026-08-14WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP58f1707a-579b-1e06-e063-6294a90a5a9f2026-08-13WarningsExact identifier
application number: M005
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
application number: M005
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-12WarningsExact identifier
application number: M005
Hecila ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.58c117cc-e039-86f6-e063-6394a90af18f2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLC93605e22-920d-43c3-bb2b-6e3116a19f5e2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLCfde7d6ea-1b44-4a88-820a-0f2e033727e12026-08-11WarningsExact identifier
application number: M005
XBOFPEN MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTWenzhou Yuyuan Pharmaceutical Co., Ltd.58c2f50c-9c9e-4989-e063-6394a90abb212026-08-11WarningsExact identifier
application number: M005
RoyceDerm Athletes foot antifungal .cream.MICONAZOLE NITRATE 2%RoyceDerm LLC58d23aa0-497e-4ece-e063-6294a90aef662026-08-11WarningsExact identifier
application number: M005
QualiLife persimmon foot and shoeUNDECYLENIC ACIDGuangdong Aimu Biological Technology Co., Ltd584966c7-ceae-91af-e063-6294a90ac1eb2026-08-10WarningsExact identifier
application number: M005
Persiancat ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.58affb96-6cfc-b1fb-e063-6294a90a340c2026-08-10WarningsExact identifier
application number: M005
Dryello Tolnaftate 1% AntifungalTOLNAFTATEProPedix, Inc.58b6820c-f601-5921-e063-6294a90aa5e92026-08-10WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP3c43ef91-bbd2-5e58-e063-6294a90a00d32026-08-05WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc57c20748-fdad-b73b-e063-6294a90a1c172026-08-04WarningsExact identifier
application number: M005
Lyssera Fungal Nail RenewalUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843c1a0-ab60-bd64-e063-6294a90af8582026-08-04WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843cc12-de66-ca47-e063-6294a90ae55b2026-08-04WarningsExact 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