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 29 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Fungal PowderMICONAZOLE NITRATETopCo Associates19c3fbc5-abde-57df-e063-6394a90a125c2025-11-06WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYTopco Associates LLC17993a9f-0d44-43a1-8608-94ee8a08b5392025-11-06WarningsExact identifier
application number: M005
DVO Estriol creamESTRIOL0.2%Guangzhou Huixue Biotechnology Co., Ltd.42e4cc84-7c00-6937-e063-6294a90a0c092025-11-05WarningsExact identifier
application number: M005
MedlineMICONAZOL NITRATEMedline Industries, LPdad58efb-cc20-577a-e053-2a95a90abd9d2025-11-03WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYHEBc6af941a-0b85-4611-a6f3-b13fcf3c4a872025-11-03WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYHEBc585605b-ecb8-4dd8-9205-a9be02d751fa2025-11-03WarningsExact identifier
application number: M005
Premier Solutions Antifungal Tolnaftate LiquidTOLNAFTATEPremier Brands of America, Inc.e1971c1c-5687-577b-e053-2a95a90ad95f2025-11-03WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYPremier Brands of America Inc.3803c643-35d1-06d4-e063-6294a90ac6f62025-11-03WarningsExact identifier
application number: M005
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEMeijer Distribution Inc03fd069d-685d-b8ac-e063-6394a90a31f82025-10-31WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYPremier Brands of America Inc.7a6a63cd-e87d-4229-8acf-b65d63909eb62025-10-31WarningsExact identifier
application number: M005
AzolenMICONAZOLE NITRATEStratus Pharmaceuticals, Inc.9c2574f3-3be4-405a-9c87-943dc6ef87772025-10-30WarningsExact identifier
application number: M005
Family Care AntifungalCLOTRIMAZOLEUnited Exchange Corp.63255079-ecf1-1e77-e053-2a91aa0a7b6c2025-10-30WarningsExact identifier
application number: M005
Miconazorb AFMICONAZOLE NITRATEAmerisourceBergen Drug Corporation13a20d21-42d5-fe56-e063-6394a90aaf572025-10-30WarningsExact identifier
application number: M005
Antifungal Liquid ContinuousMICONAZOLE NITRATEFamily Dollar Services, Inc17cc4601-f946-df8b-e063-6394a90a38972025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYARMY & AIR FORCE EXCHANGE SERVICE932b1be8-3dbb-49ae-822a-c44a24fbe36a2025-10-30WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYGEISS, DESTIN AND DUNN, INC.c367c2e8-5423-bf01-e053-2a95a90ab8e92025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYHarris Teeter, LLC636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHarris Teeter, LLCf140e9bb-507b-4048-8b7b-8cc51b6a497d2025-10-30WarningsExact identifier
application number: M005
HEB Athlete Foot AntifungalMICONAZOLE NITRATEHEB2e204111-b5d3-0220-e063-6294a90a67bb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDKroger Co.0cfebac3-684d-4599-b75f-9a82708db7172025-10-30WarningsExact 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