FDA.reportPublic FDA data

Nail Fungus Treatment Pen

Product NDC
85966-005
11-digit product format
859660005
Labeler code
85966
Product ID
85966-005_53693514-54f6-75ab-e063-6294a90a76eb
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID, TOLNAFTATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-29
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
Nail Fungus Treatment Pen
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
3fe842e1-b3db-c003-e063-6394a90a46b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-005-01Nail Fungus Treatment Pen3 in 1 BOXLIQUID32
85966-005-01Nail Fungus Treatment Pen5 mL in 1 BOTTLELIQUID52

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
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN3fe842e1-b3db-c003-e063-6394a90a46b82
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD3fe842e1-b3db-c003-e063-6394a90a46b82
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY3fe842e1-b3db-c003-e063-6394a90a46b82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85966-005-01859660005013 BOTTLE in 1 BOX (85966-005-01) / 5 mL in 1 BOTTLE3 bottle2025-09-29NoNoCurrent