FDA.reportPublic FDA data

TEGASOLVE TOENAIL FUNGUS TREATMENT

Product NDC
85578-003
11-digit product format
855780003
Labeler code
85578
Product ID
85578-003_375b0515-1b20-23b8-e063-6294a90a9d68
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid 25%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Zhengzhou Hangrui Network Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-12
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
TEGASOLVE TOENAIL FUNGUS TREATMENT
Listing expiration
2026-12-31

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
375b0515-1b1f-23b8-e063-6294a90a9d68Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85578-003-01TEGASOLVE TOENAIL FUNGUS TREATMENT30 mL in 1 BOTTLELIQUID301
85578-003-01TEGASOLVE TOENAIL FUNGUS TREATMENT1 in 1 BOXLIQUID11

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 26 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.457c705a-9c49-c8c5-e063-6394a90a6aa32025-12-08WarningsExact identifier
application number: M005
Tolnaftate Antifungal PowderTOLNAFTATESCHOLL'S WELLNESS COMPANY LLC2a0e006b-60b1-41b9-a5d2-ff0e34b48ff52025-12-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions1e7e74f6-9bca-48ab-804a-a7a81df3b6082025-12-05WarningsExact identifier
application number: M005
Oiangna Tea Tree Oil AntifungalCLOTRIMAZOLE 1%Guangzhou Huixue Biotechnology Co., Ltd.453452a7-c613-6111-e063-6294a90aca812025-12-05WarningsExact identifier
application number: M005
Tinactin AntifungalTOLNAFTATEBayer HealthCare LLC.5f95be36-6efa-4dfb-9a40-88f4ce1de2b32025-12-05WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.c3b715a9-233a-401a-ba60-f78c1ddf1ded2025-12-05WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLC.b584e17f-ed43-43bd-b643-dfa48edd78c62025-12-05WarningsExact identifier
application number: M005
Fungicure Night CreamCLOTRIMAZOLEKobayashi Healthcare International, Inc.43029403-2afd-cfa1-e063-6394a90a99a32025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevention DeoTOLNAFTATEBayer HealthCare LLC.9e8bfb78-ad81-93d0-e053-2995a90aa41d2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer Healthcare LLC.0c53cf0f-767e-a422-e063-6394a90ab7642025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0a80a5b0-3216-46f6-8801-7066ef59aee42025-12-04WarningsExact identifier
application number: M005
Lotrimin AntifungalCLOTRIMAZOLEBayer HealthCare LLC.f9536683-3f32-4c71-9b6a-70f8611e3dcf2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF DeodorantMICONAZOLE NITRATEBayer HealthCare LLC.0bee54eb-df2f-15fe-e063-6294a90a2fd22025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0beda157-efd2-5245-e063-6394a90a69112025-12-04WarningsExact identifier
application number: M005
Lotrimin AFMICONAZOLE NITRATEBayer Healthcare LLC.163996c6-af54-21ac-e063-6394a90ac05c2025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevent DeodorantTOLNAFTATEBayer HealthCare LLC.1bb961cd-b6e6-3aff-e063-6394a90a432e2025-12-04WarningsExact identifier
application number: M005
Tinactin DeodorantTOLNAFTATEBayer HealthCare LLC.1751d576-e94a-d7d1-e063-6294a90a03ff2025-12-04WarningsExact identifier
application number: M005
Tinactin Jock ItchTOLNAFTATEBayer HealthCare LLC163ab4df-6e4a-6239-e063-6294a90a1cd02025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLCbb878f31-2189-4427-aacf-5bce96d759782025-12-04WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLCda948ef3-3709-4bfc-9d17-f6f1ea3253432025-12-04WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN375b0515-1b1f-23b8-e063-6294a90a9d681
998329undecylenic acid 250 MG/ML Topical SolutionSCD375b0515-1b1f-23b8-e063-6294a90a9d681
998329undecylenic acid 25 % Topical SolutionSY375b0515-1b1f-23b8-e063-6294a90a9d681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85578-003-01855780003011 BOTTLE in 1 BOX (85578-003-01) / 30 mL in 1 BOTTLE1 bottle2025-06-12NoNoCurrent