FDA.reportPublic FDA data

TOENAIL FUNGUS TREATMENT

Product NDC
85569-005
11-digit product format
855690005
Labeler code
85569
Product ID
85569-005_4c030904-f158-0d1c-e063-6394a90ad3a8
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

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 1 of 52 · 1,022 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005
1% ketoconazole anti dandruff1% KETOCONAZOLE ANTI DANDRUFF SHAMPOOFast Sold LLC7bb3598c-9597-4f3d-9a68-bd95657379282026-08-22WarningsExact identifier
application number: M005
JELVOXA ANTIFUNGALUNDECYLENIC ACIDWuhan Ruihengjie Technology Co., Ltd.59a2f16e-ef72-f1cb-e063-6394a90abb282026-08-22WarningsExact identifier
application number: M005
Viachs ANTIFUNGAL CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.598b7e0c-c76d-2f56-e063-6394a90a70532026-08-21WarningsExact identifier
application number: M005
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-21WarningsExact identifier
application number: M005
GPPEE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.598d05bc-459d-71cf-e063-6394a90a19322026-08-21WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
application number: M005
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
application number: M005
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
application number: M005
BYT BANGYTONG FOLLICULITIS5% BENZOYL PEROXIDE FOLLICULITISShenzhen Jindali Technology Co., Ltd595363f9-6aee-93a5-e063-6394a90a0f0e2026-08-18WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEShield Line LLC9ddb13cd-34ed-2d63-e053-2a95a90ad9da2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESTOLNAFTATEYunqi Cosmetics (Shenzhen) Co., Ltd5939c492-6481-ddae-e063-6294a90a40bb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact 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