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 29 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlphaTip Nail Repair PenNAIL REPAIR PENGuangzhou Qiexiran Cosmetics Co., Ltd.435c7973-8a67-8f51-e063-6394a90af58f2025-11-11WarningsExact identifier
application number: M005
Pharmlitalia Antifungal Medicated BodyTOLNAFTATEFoshan Sugar Max Cosmetics CO.,Ltd399302d2-0da4-4167-8884-b34a9aba86862025-11-10WarningsExact identifier
application number: M005
PerfectHeal AntifungalCLOTRIMAZOLEZhejiang Dingtai Pharmaceutical Co., Ltdd9750991-8f10-4d6b-8841-bea022d5ad732025-11-10WarningsExact identifier
application number: M005
PiYanPing AntifungalMICONAZOLE NITRATEZhejiang Dingtai Pharmaceutical Co., Ltd840364aa-d799-4163-a9e8-3f10c18f86ae2025-11-10WarningsExact identifier
application number: M005
SKINHEAL ANTIFUNGALTOLNAFTATEZhejiang Dingtai Pharmaceutical Co., Ltd570ee9fb-a495-4a99-9215-0cd1bb2e02902025-11-10WarningsExact identifier
application number: M005
HUA TUO XIAN GAO ANTIFUNGALCLOTRIMAZOLEMADISON ONE ACME INCe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d2025-11-10WarningsExact identifier
application number: M005
Selan AntifungalSELAN ANTIFUNGALTrividia Manufacturing Solutions, Inc8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a292025-11-07WarningsExact identifier
application number: M005
Fortinia UltraCLOTRIMAZOLE 1%The Podiatree Company43065a59-fb81-b1c2-e063-6294a90a36e02025-11-07WarningsExact identifier
application number: M005
MICOCLEARCLOTRIMAZOLE ANTIFUNGALRising Pharma Holdings, Inc.d75b7d3c-3f1c-47e1-8122-4645f56a444e2025-11-06WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP1ea444eb-f2f5-8c63-e063-6294a90acac82025-11-06WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL POWDER SPRAYPremier Brands of America Inc.38ccf19c-2290-ad99-e063-6394a90a54692025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL POWDER SPRAY WITH BAKING SODATarget Corporation37792b12-c3dc-558f-e063-6294a90a7e752025-11-06WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYTopco Associates LLC5f8ae9ab-5e34-7a60-e053-2991aa0a98172025-11-06WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE JOCK ITCH POWDER SPRAY TALC FREETopco Associates LLC5f8ac6b7-c46c-226c-e053-2991aa0a96062025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYTopco Associates LLC3dd0df06-3c74-4c34-a69e-4240945f5fa52025-11-06WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATETopCo Associates19c3fbc5-abde-57df-e063-6394a90a125c2025-11-06WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYTopco Associates LLC17993a9f-0d44-43a1-8608-94ee8a08b5392025-11-06WarningsExact identifier
application number: M005
DVO Estriol creamESTRIOL0.2%Guangzhou Huixue Biotechnology Co., Ltd.42e4cc84-7c00-6937-e063-6294a90a0c092025-11-05WarningsExact identifier
application number: M005
MedlineMICONAZOL NITRATEMedline Industries, LPdad58efb-cc20-577a-e053-2a95a90abd9d2025-11-03WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYHEBc6af941a-0b85-4611-a6f3-b13fcf3c4a872025-11-03WarningsExact 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