FDA.reportPublic FDA data

TOENAIL FUNGUS TREATMENT

Product NDC
85595-002
11-digit product format
855950002
Labeler code
85595
Product ID
85595-002_51a18924-63cd-4fb8-e063-6394a90af574
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Fengda Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-12
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 productproduct85595-002DDiscontinued by firm2026-09-14
excluded packagepackage85595-00285595-002-01DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85595-002-01TOENAIL FUNGUS TREATMENT2 in 1 BOXGEL21
85595-002-01TOENAIL FUNGUS TREATMENT14 mL in 1 TUBEGEL141

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 1 of 51 · 1,015 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALMICONAZOLE NITRATE 2% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4a832f39-ac11-d8b3-e063-6394a90acb392026-09-06WarningsExact identifier
application number: M005
Noicaky FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5adcc5f7-2d47-2ad7-e063-6294a90a48482026-09-06WarningsExact identifier
application number: M005
LIFE66II ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab83796-0780-3b58-e063-6394a90a2e4e2026-09-05WarningsExact identifier
application number: M005
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsExact identifier
application number: M005
ANTIFUNGAL BODY WASHTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.5a695043-f776-df5a-e063-6394a90ac2742026-09-01WarningsExact identifier
application number: M005
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEInvaDerm Corporation5a5cfed9-0587-7bef-e063-6294a90a64bf2026-08-31WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
application number: M005
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005
1% ketoconazole anti dandruff1% KETOCONAZOLE ANTI DANDRUFF SHAMPOOFast Sold LLC7bb3598c-9597-4f3d-9a68-bd95657379282026-08-22WarningsExact identifier
application number: M005
JELVOXA ANTIFUNGALUNDECYLENIC ACIDWuhan Ruihengjie Technology Co., Ltd.59a2f16e-ef72-f1cb-e063-6394a90abb282026-08-22WarningsExact identifier
application number: M005
Viachs ANTIFUNGAL CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.598b7e0c-c76d-2f56-e063-6394a90a70532026-08-21WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85595-002-01855950002012 TUBE in 1 BOX (85595-002-01) / 14 mL in 1 TUBE2 tube2026-05-12NoNoHistorical