Fungal Nail Patches

Product NDC
85038-005
11-digit product format
850380005
Labeler code
85038
Product ID
85038-005_4e77eb19-8763-ad20-e063-6294a90acee1
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE, UNDECYLENIC ACID
Dosage form
PATCH
Route
TOPICAL
Labeler
Lianjiang Shanlilai E-commerce Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-19
Substance
UNDECYLENIC ACID; TOLNAFTATE
Active strength
25; 1 g/1001; g/1001
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
Fungal Nail Patches
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/1001
TOLNAFTATE1 g/1001

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
2700164Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
299a63ad-f321-117c-e063-6394a90a3a22Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85038-005-01Fungal Nail Patches1 in 1 PATCHPATCH12
85038-005-01Fungal Nail Patches20 in 1 PACKAGEPATCH202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85038-005FUNGAL NAIL PATCHES (TOLNAFTATE, UNDECYLENIC ACID) PATCH [LIANJIANG SHANLILAI E-COMMERCE CO., LTD.]1Current NDC, 2 package rows20241222_299a63ad-f321-117c-e063-6394a90a3a22.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 46 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEASTONEA LABS PRIVATE LIMITEDe66191a6-0c3c-7319-e053-2a95a90aae842024-06-25WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsb63a3fe5-5684-41bc-ad6c-69c54e5b942d2024-06-20WarningsExact identifier
application number: M005
THERA Antifungal BodyMICONAZOLE NITRATEMcKesson Medical-Surgical Inc.31096041-28c9-4b16-bbd1-dbadefd375052024-06-14WarningsExact identifier
application number: M005
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
application number: M005
Secura ProtectiveZINC OXIDESmith & Nephew Medical Ltdb077aa64-49a3-42ee-abb3-88f833635b932024-06-12WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.627375fb-2f20-16bc-e053-2a91aa0a15422024-06-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLECardinal Health 110 dba LEADER199df107-3384-6e03-e063-6294a90afc382024-05-29WarningsExact identifier
application number: M005
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
application number: M005
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
application number: M005
CANESPIESTOLNAFTATEOPMX LLCe2f9eedc-3c43-416b-85b5-ba07fb5fb4db2024-05-17WarningsExact identifier
application number: M005
Up and Up AntifungalTOLNAFTATE 1%Target Corporation8f54c8c7-6771-49c3-b429-53aa6df54dc52024-05-08WarningsExact identifier
application number: M005
Up and Up Athletes FootCLOTRIMAZOLE 1%Target Corporation52b61859-11ae-4990-aa0c-9dc1dd00adf42024-05-08WarningsExact identifier
application number: M005
ADI Medical PVP-I Pouch, FoilPOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0e8baf24-0c67-5511-e063-6394a90acaa12024-05-02WarningsExact identifier
application number: M005
Caseys Antimicrobial Hand SanitizerETHYL ALCOHOLNavajo Manufacturing Company Inc.78863024-390c-4ff9-8ed6-02af07902a302024-04-29WarningsExact identifier
application number: M005
MQUPIN Liquid Fungal Nail TreatmentLIQUID FUNGAL NAIL TREATMENTZhengzhou Miaoqi Medical Technology Co., Ltd.14782f8c-3b29-1d88-e063-6294a90ac3e42024-03-25WarningsExact identifier
application number: M005
ETADERM Advanced Antifungal SupportUNDECYLENIC ACIDNUEPHASE LLCadb12a1c-ece9-4a59-a62c-89d212c57e6f2024-03-13WarningsExact identifier
application number: M005
Dermachange JockMICONAZOLE NITRATEPrivate label Beauty and Wellness12eef049-76c9-1450-e063-6394a90a00ea2024-03-05WarningsExact identifier
application number: M005
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEBryant Ranch Prepackfbbd159c-217e-46d3-963c-ba0bd1e9bbe82024-01-29WarningsExact identifier
application number: M005
Target Jock ItchCLOTRIMAZOLE 1%Target Corporationf44d4c44-99d1-413f-b9c3-8330bdd21abb2024-01-17WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700164tolnaftate 1 % / undecylenic acid 25 % Medicated PatchPSN299a63ad-f321-117c-e063-6394a90a3a222
2700164tolnaftate 0.01 MG/MG / undecylenic acid 0.25 MG/MG Medicated PatchSCD299a63ad-f321-117c-e063-6394a90a3a222
2700164tolnaftate 1 % / undecylenic acid 25 % Medicated PatchSY299a63ad-f321-117c-e063-6394a90a3a222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85038-005-018503800050120 PATCH in 1 PACKAGE (85038-005-01) / 1 PATCH in 1 PATCH20 patch2024-12-19NoNoCurrent