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 44 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Rainer s Vaginal CreamMICONAZOLE NITRATEPlexoris Health Care Products, Llc1f0ee635-c70d-4194-a01d-370ca5c22fcd2024-12-11WarningsExact identifier
application number: M005
BOA VIDA AntifungalMICONAZOLE NITRATECentral Solutions Inc69c5340d-9abd-43bf-a90b-9568d615f06f2024-12-09WarningsExact identifier
application number: M005
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsExact identifier
application number: M005
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
application number: M005
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC31df570a-35ae-41a2-b04a-fce65e9d596d2024-11-21WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
application number: M005
WINCO ANTIFUNGALTOLNAFTATE 1%WinCo Foods LLC46b58c71-d62e-4b3d-b2ec-65407032eeea2024-11-21WarningsExact identifier
application number: M005
Dynarex AntifungalANTIFUNGALDynarex Corporationab5b6467-c158-4407-9d52-3c07310306802024-11-20WarningsExact identifier
application number: M005
Terrasil JockItch Treatment Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions8afe11c1-0a85-4255-8eba-e8cbde0759a02024-11-20WarningsExact identifier
application number: M005
Terrasil Ringworm Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfc2b740a-49c1-4a01-a94c-8cade52a2b822024-11-20WarningsExact identifier
application number: M005
MICONAZOLE NITRATEMICONAZOLE NITRATEALLIED TRADE LINK LLC25520dba-0159-2a3f-e063-6294a90a4c332024-11-12WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
application number: M005
AntifungalTOLNAFTATE 1%Chain Drug Marketing Association Inc.26303499-dc58-f417-e063-6394a90a0a1b2024-11-05WarningsExact identifier
application number: M005
AZOLENMICONAZOLE NITRATESTRATUS PHARMACEUTICALS INC3264bd0a-c628-404b-8c09-8586682d054e2024-10-31WarningsExact identifier
application number: M005
BACITRACIN ZINCBACITRACIN ZINCSTRATUS PHARMACEUTICALS INCb2cb3a96-b0ca-42ee-8056-91d5450fb3762024-10-31WarningsExact identifier
application number: M005
Premier Value Antifungal Maximum StrengthUNDECYLENIC ACIDPHARMACY VALUE ALLIANCE, LLCf5694ee5-616c-40f6-8da4-c3620dbcd6f72024-10-28WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEChain Drug Marketing Association Inc.24ff5ad7-2ff9-b254-e063-6394a90a27a72024-10-21WarningsExact identifier
application number: M005
Micomitin AntifungalTOLNAFTATEPureTek Corporationde9842ba-0254-8ae1-e053-2995a90a06642024-10-16WarningsExact identifier
application number: M005
Ongo - FinTOLNAFTATEEfficient Laboratories Inc.bb5fb71f-bee0-42fa-9c9f-6231b555324c2024-10-14WarningsExact 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