FDA.reportPublic FDA data

TOENAIL FUNGUS TREATMENT Liquid

Product NDC
85038-002
11-digit product format
850380002
Labeler code
85038
Product ID
85038-002_4e77eb15-0dea-0778-e063-6394a90ad359
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE, UNDECYLENIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
Lianjiang Shanlilai E-commerce Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-11
Substance
UNDECYLENIC ACID; TOLNAFTATE
Active strength
25; 1 g/100mL; 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 Liquid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/100mL
TOLNAFTATE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2691548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
28fc7049-e367-42bf-e063-6394a90a6f06Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85038-002-01TOENAIL FUNGUS TREATMENT Liquid30 mL in 1 BOTTLELIQUID302
85038-002-01TOENAIL FUNGUS TREATMENT Liquid1 in 1 PACKAGELIQUID12
85038-002-02TOENAIL FUNGUS TREATMENT Liquid2 in 1 PACKAGELIQUID22
85038-002-02TOENAIL FUNGUS TREATMENT Liquid30 mL in 1 BOTTLELIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85038-002TOENAIL FUNGUS TREATMENT LIQUID (TOLNAFTATE, UNDECYLENIC ACID) LIQUID [LIANJIANG SHANLILAI E-COMMERCE CO., LTD.]1Current NDC, 4 package rows20241213_28fc7049-e367-42bf-e063-6394a90a6f06.zip

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 32 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arflom Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.413e76b5-263c-62fa-e063-6294a90a92142025-10-15WarningsExact identifier
application number: M005
VTROUY Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.413f6399-dda1-8dd9-e063-6394a90a573d2025-10-15WarningsExact identifier
application number: M005
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Incf647308a-ea6c-47a9-a124-60e7888afac22025-10-14WarningsExact identifier
application number: M005
Tripenicol SUNDECYLENIC ACIDTrifluent Pharma LLCb57500e1-ea6f-4043-99d6-326a7eb57f2f2025-10-14WarningsExact identifier
application number: M005
TriTolnacide CTOLNAFTATETrifluent Pharma LLC12b53c2a-b073-43db-88d9-ede8300626aa2025-10-14WarningsExact identifier
application number: M005
Tritolnacide STOLNAFTATETrifluent Pharma LLCb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d82025-10-14WarningsExact identifier
application number: M005
Tripenicol CUNDECYLENIC ACIDTrifluent Pharma LLC0a7477da-370f-451f-8993-8c675c1686962025-10-14WarningsExact identifier
application number: M005
Povidone-Iodine PrepPOVIDONE-IODINEO&M HALYARD, INC.f3e0af11-39b6-44a0-8f84-a4b36631e8f02025-10-09WarningsExact identifier
application number: M005
seebeellar antifungal cream 2% miconazoleSEEBEELLAR ANTIFUNGAL CREAM 2% MICONAZOLEGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd40c491f6-43b4-534e-e063-6294a90a73d62025-10-09WarningsExact identifier
application number: M005
Hermon Antifungal Jock Itch Body WashTOLNAFTATE 1%Beautivity LLC409ef5c0-dfe5-f26a-e063-6294a90a27452025-10-08WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEMarlex Pharmaceuticals Incd6e95c99-e055-436a-8ee6-40d6e199eaca2025-10-08WarningsExact identifier
application number: M005
TM-ClotrimazoleCLOTRIMAZOLE 1%Singular Dreamer, Ltd dba True Markerd6a9755a-9ed1-4e7d-8e73-25c169d6c6b12025-10-06WarningsExact identifier
application number: M005
antibacterial body washSILVERGuangdong Quaker Daily Chemical Co., LTD3fff8d3e-1944-4813-e063-6294a90a1a1d2025-09-30WarningsExact identifier
application number: M005
Tobcharm Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.4001247d-4704-8786-e063-6394a90a083a2025-09-30WarningsExact identifier
application number: M005
Silka AntifungalTOLNAFTATEGenomma Lab USAfb1dc636-837f-491c-97c1-e74288aebc272025-09-30WarningsExact identifier
application number: M005
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.3d48a3c6-b7d6-6794-e063-6294a90afff92025-09-29WarningsExact identifier
application number: M005
LEADER ATHLETES FOOT CLOTRIMAZOLECLOTRIMAZOLELEADERdcea717b-b097-4a40-8e38-05212731a7ef2025-09-29WarningsExact identifier
application number: M005
First Aid AntispeticBENZALKONIUM CHLORIDEUnishieldf72851ba-bbdd-5533-e053-6294a90a82162025-09-28WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe861cc-c972-a328-e063-6294a90afc8f2025-09-28WarningsExact identifier
application number: M005
Tea Tree Oil Antifungal Foot CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe8fc55-bd64-a4a8-e063-6294a90ad18c2025-09-28WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN28fc7049-e367-42bf-e063-6394a90a6f062
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD28fc7049-e367-42bf-e063-6394a90a6f062
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY28fc7049-e367-42bf-e063-6394a90a6f062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85038-002-01850380002011 BOTTLE in 1 PACKAGE (85038-002-01) / 30 mL in 1 BOTTLE1 bottle2024-12-11NoNoCurrent
85038-002-02850380002022 BOTTLE in 1 PACKAGE (85038-002-02) / 30 mL in 1 BOTTLE2 bottle2024-12-11NoNoCurrent