FDA.reportPublic FDA data

Lofuanna FUNGAL NAIL PATCHES

Product NDC
83804-010
11-digit product format
838040010
Labeler code
83804
Product ID
83804-010_45a532ff-694a-9799-e063-6394a90a8c4c
Type
HUMAN OTC DRUG
Nonproprietary name
Tea Tree Oil
Dosage form
PATCH
Route
TOPICAL
Labeler
Shenzhen Shandian Jingling Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-18
Substance
TEA TREE OIL
Active strength
.1 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct83804-010DDiscontinued by firm2026-10-12
excluded packagepackage83804-01083804-010-01DDiscontinued by firm2026-10-12

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
Lofuanna FUNGAL NAIL PATCHES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEA TREE OIL.1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VIF565UC2GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43da9ec2-5f2f-dfce-e063-6394a90aeccaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83804-010-01Lofuanna FUNGAL NAIL PATCHES32 in 1 BAGPATCH324
83804-010-01Lofuanna FUNGAL NAIL PATCHES1 in 1 PATCHPATCH14

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 28 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cura Hongo AntifungalCLOTRIMAZOLEPharmadel LLCdf031309-2778-00cf-e053-2a95a90a5eea2025-11-17WarningsExact identifier
application number: M005
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltda7433f39-a8d9-4c78-864d-d7ef193a7daf2025-11-16WarningsExact identifier
application number: M005
Mint Blast Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLCf7fcac19-7b72-4b7a-a28e-669a0eebec9c2025-11-15WarningsExact identifier
application number: M005
Lavender Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC9db58924-a84d-4763-badb-b3aeb46e1ea62025-11-15WarningsExact identifier
application number: M005
Citrus Detox Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC6585c9f5-a6cb-4534-9a61-ecbb6dcb7bdc2025-11-15WarningsExact identifier
application number: M005
AlphaTip Nail Repair PenNAIL REPAIR PENGuangzhou Qiexiran Cosmetics Co., Ltd.435c7973-8a67-8f51-e063-6394a90af58f2025-11-11WarningsExact identifier
application number: M005
Pharmlitalia Antifungal Medicated BodyTOLNAFTATEFoshan Sugar Max Cosmetics CO.,Ltd399302d2-0da4-4167-8884-b34a9aba86862025-11-10WarningsExact identifier
application number: M005
PerfectHeal AntifungalCLOTRIMAZOLEZhejiang Dingtai Pharmaceutical Co., Ltdd9750991-8f10-4d6b-8841-bea022d5ad732025-11-10WarningsExact identifier
application number: M005
PiYanPing AntifungalMICONAZOLE NITRATEZhejiang Dingtai Pharmaceutical Co., Ltd840364aa-d799-4163-a9e8-3f10c18f86ae2025-11-10WarningsExact identifier
application number: M005
SKINHEAL ANTIFUNGALTOLNAFTATEZhejiang Dingtai Pharmaceutical Co., Ltd570ee9fb-a495-4a99-9215-0cd1bb2e02902025-11-10WarningsExact identifier
application number: M005
HUA TUO XIAN GAO ANTIFUNGALCLOTRIMAZOLEMADISON ONE ACME INCe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d2025-11-10WarningsExact identifier
application number: M005
Selan AntifungalSELAN ANTIFUNGALTrividia Manufacturing Solutions, Inc8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a292025-11-07WarningsExact identifier
application number: M005
Fortinia UltraCLOTRIMAZOLE 1%The Podiatree Company43065a59-fb81-b1c2-e063-6294a90a36e02025-11-07WarningsExact identifier
application number: M005
MICOCLEARCLOTRIMAZOLE ANTIFUNGALRising Pharma Holdings, Inc.d75b7d3c-3f1c-47e1-8122-4645f56a444e2025-11-06WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP1ea444eb-f2f5-8c63-e063-6294a90acac82025-11-06WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL POWDER SPRAYPremier Brands of America Inc.38ccf19c-2290-ad99-e063-6394a90a54692025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL POWDER SPRAY WITH BAKING SODATarget Corporation37792b12-c3dc-558f-e063-6294a90a7e752025-11-06WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYTopco Associates LLC5f8ae9ab-5e34-7a60-e053-2991aa0a98172025-11-06WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE JOCK ITCH POWDER SPRAY TALC FREETopco Associates LLC5f8ac6b7-c46c-226c-e053-2991aa0a96062025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYTopco Associates LLC3dd0df06-3c74-4c34-a69e-4240945f5fa52025-11-06WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83804-010-018380400100132 PATCH in 1 BAG (83804-010-01) / 1 PATCH in 1 PATCH32 patch2025-11-18NoNoCurrent