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 20 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER TINEA VERSICOLOR CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3db832f4-630d-72a2-e063-6394a90a08dc2026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEChain Drug Consortium, LLC5f9edcf9-b99e-65a2-e053-2a91aa0af5652026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Consortium, LLC5fafc16d-7257-fc88-e053-2991aa0a67c42026-02-12WarningsExact identifier
application number: M005
Kerova Miconazole NitrateMICONAZOLE NITRATEGuangzhou Bixiaoyu Trading Co., Ltd.3b8b5547-f8d1-9e48-e063-6294a90af4292026-02-12WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLCa980ff33-2b6d-3065-e053-2995a90ae9742026-02-11WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4a8265c5-9c69-a36a-e063-6294a90ab2922026-02-11WarningsExact identifier
application number: M005
Tuymec FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.4a983b42-9723-7a3a-e063-6394a90ae7b22026-02-11WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT SPRAYCVS Pharmacy1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c2026-02-10WarningsExact identifier
application number: M005
Kerova ANTIFUNGALCLOTRIMAZOLEGuangzhou Bixiaoyu Trading Co., Ltd.4a7b48cf-72c3-be63-e063-6394a90a1efe2026-02-10WarningsExact identifier
application number: M005
Kerova ClotrimazoleANTIFUNGALGuangzhou Bixiaoyu Trading Co., Ltd.4a7b9658-f411-299d-e063-6394a90af9ce2026-02-10WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC3b1209fc-9d6b-2f55-e063-6394a90ac2ad2026-02-10WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC0fdd1658-5759-8a42-e063-6394a90a72712026-02-10WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4a633da8-dcba-349c-e063-6294a90a77022026-02-09WarningsExact identifier
application number: M005
Fungus Master Antifungal TreatmentMICONAZOLE NITRATEEbanel Laboratories, Incf7b011b2-11e5-46f1-afed-89f438985e002026-02-09WarningsExact identifier
application number: M005
OSIMOON Toenail Fungus TreatmentTOENAIL FUNGUS TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4a7061a9-8ba2-72b8-e063-6294a90a4d9a2026-02-09WarningsExact identifier
application number: M005
CLOTRIMAZOLE 1%CLOTRIMAZOLEPHARMACY CHOICE INC43852cfb-6d28-e54f-e063-6394a90aa0902026-02-08WarningsExact identifier
application number: M005
ASSIELF ANTIFUNGAL PENUNDECYLENIC ACIDShenzhen Yuanbang International Logistics Co., Ltd4a5d8e86-6401-7556-e063-6394a90acce12026-02-08WarningsExact identifier
application number: M005
Dryello Dual Action Relief for Athlete FootTOLNAFTATEProPedix, Inc.359478dd-02c9-05e5-e063-6294a90a41ed2026-02-06WarningsExact identifier
application number: M005
HEALMUSZ ClotrimazoleCLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a326159-a6a7-c1d6-e063-6294a90a3b892026-02-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWal-Mart Stores, Inc.17d0486e-e8b5-3afe-e063-6394a90aa3842026-02-04WarningsExact 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