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
Ingredient	Strength
UNDECYLENIC ACID	25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K3D86KJ24N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3bb000dc-5e6c-b43b-e063-6394a90a63a9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85569-005-01	TOENAIL FUNGUS TREATMENT	30 mL in 1 CARTON	LIQUID	30		2

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 39 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terrasil Anti-Fungal Treatment MAX	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	db356cc8-f473-4eb2-b8d8-72606fca9dc0	2025-05-23	Warnings	Exact identifier application number: M005
terrasil Folliculitis Cream Maximum Strength	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	35d54756-00dd-bbe1-e063-6394a90a9e02	2025-05-23	Warnings	Exact identifier application number: M005
Paume Moisturizing Antibacterial Hand Gel	ALCOHOL	Paume Inc	b6fe12bf-6430-5861-e053-2a95a90a6c8f	2025-05-22	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	TOLNAFTATE	Trifecta Pharmaceuticals Usa Llc	96a40ccd-17f7-4e4e-98da-207802fa2b2d	2025-05-15	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Cardinal Health 110 dba LEADER	34f4c733-2eb2-0db0-e063-6394a90a6431	2025-05-13	Warnings	Exact identifier application number: M005
Dr CANUSO fungal nail eraser	TOLNAFTATE OIL	Renu Laboratories, LLC	2083f9ed-09d6-26e6-e054-00144ff88e88	2025-05-13	Warnings	Exact identifier application number: M005
Dr. Canuso foot repair serum	TOLNAFTATE SERUM	Renu Laboratories, LLC	1fcc52c5-7030-13cb-e054-00144ff8d46c	2025-05-13	Warnings	Exact identifier application number: M005
Private Label Antifungal Barrier Cream	MICONAZOLE NITRATE ANTIFUNGAL CREAM	Swiss-American CDMO, LLC	2ee40c37-504b-43ed-960a-535015407492	2025-05-09	Warnings	Exact identifier application number: M005
Osimoon Fungal Nail Treatment Kit	OSIMOON FUNGAL NAIL TREATMENT KIT	Guangzhou Zanming Trading Co., Ltd.	34aec10d-a0d0-d956-e063-6394a90a39b2	2025-05-09	Warnings	Exact identifier application number: M005
ANTIFUNGAL	MICONAZOLE	VIVE HEALTH LLC	33d9c724-d4c4-2597-e063-6294a90aa5f3	2025-04-28	Warnings	Exact identifier application number: M005
ANTIFUNGAL	CLOTRIMAZOLE	VIVE HEALTH LLC	33db98f5-f6d9-742a-e063-6394a90a2a03	2025-04-28	Warnings	Exact identifier application number: M005
Foot Cure Nail Repair Pen	ANTIFUNGAL NAIL REPAIR PEN	SANSAR, LLC	9c823e27-8bb3-4ccd-bf7e-a99d45908e88	2025-04-25	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER CUCUMBER MELON	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380404d-9499-e9fb-e063-6394a90a0f27	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUT	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380fe6d-e059-401a-e063-6394a90a787a	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINE	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3381cefb-281c-9b85-e063-6294a90acfd9	2025-04-24	Warnings	Exact identifier application number: M005
Wish Hand Sanitizer Coconut Cream White Florals	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33826aef-6e50-2730-e063-6394a90a727b	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER GOLDEN CITRUS	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3391a78e-525d-c2ba-e063-6394a90a1e99	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIO	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33927939-a9dc-ab67-e063-6394a90a71cc	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER BLACK PLUM VANILLA	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	336c751f-6a33-ca55-e063-6394a90a9749	2025-04-23	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOOD	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	337e4526-238a-bc2d-e063-6394a90a5a27	2025-04-23	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K3D86KJ24N	UNDECYLENIC ACID	112-38-9	UNDECYLENIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2677690	tolnaftate 1 % Medicated Patch	PSN	3d4bbc65-955f-8fd8-e063-6294a90adc44	2
998329	undecylenic acid 25 % Topical Solution	PSN	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2
998329	undecylenic acid 25 % Topical Solution	PSN	3d4bbc65-955f-8fd8-e063-6294a90adc44	2
2677690	tolnaftate 0.01 MG/MG Medicated Patch	SCD	3d4bbc65-955f-8fd8-e063-6294a90adc44	2
998329	undecylenic acid 250 MG/ML Topical Solution	SCD	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2
998329	undecylenic acid 250 MG/ML Topical Solution	SCD	3d4bbc65-955f-8fd8-e063-6294a90adc44	2
2677690	tolnaftate 1 % Medicated Patch	SY	3d4bbc65-955f-8fd8-e063-6294a90adc44	2
998329	undecylenic acid 25 % Topical Solution	SY	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2
998329	undecylenic acid 25 % Topical Solution	SY	3d4bbc65-955f-8fd8-e063-6294a90adc44	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85569-005-01	85569000501	30 mL in 1 CARTON (85569-005-01)	30 ml	2025-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Update-85569-005-01	100 KARMA INC	2026-07-03	HUMAN OTC DRUG LABEL	3
Update-85569-010-01	100 KARMA INC	2026-07-03	HUMAN OTC DRUG LABEL	3