FDA.reportPublic FDA data

NDC 52261-5800-1 - Botanimedix OnychoRX Antifungal Nail Gel

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52261-5800
Requested NDC
52261-5800-1
Package NDCs from labels
52261-5800-1, 52261-5800-0
Manufacturer
Cosco International, Inc.
Effective date
2020-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Botanimedix OnychoRX Antifungal Nail GelCosco International, Inc.2020-01-29HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-5800-02025-01-30C16284748780-12cef2736-8970-d83d-e063-dadaa90ab31fBotanimedix OnychoRX Antifungal Nail Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-5800-0Botanimedix OnychoRX Antifungal Nail Gel1 in 1 CARTONGEL13
52261-5800-1Botanimedix OnychoRX Antifungal Nail Gel0.002 kg in 1 BOTTLE, WITH APPLICATORGEL0.0023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-5800BOTANIMEDIX ONYCHORX ANTIFUNGAL NAIL GEL (UNDECYLENIC ACID) GEL [COSCO INTERNATIONAL, INC.]3Legacy NDC, 2 package rows20200327_16e8a074-905e-41b5-bb46-c7bb3e914f7a.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 2 of 31 · 619 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: WR1WPI7EW8
Lyssera Fungal Nail RenewalUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843c1a0-ab60-bd64-e063-6294a90af8582026-08-04WarningsExact identifier
unii: K3D86KJ24N
YAMANGU FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843cc12-de66-ca47-e063-6294a90ae55b2026-08-04WarningsExact identifier
unii: K3D86KJ24N
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HOUKEA Bee Venom Skin Restoration CreamGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.57a8a8e9-7f18-ad01-e063-6394a90a1eac2026-07-29WarningsExact identifier
unii: VIF565UC2G
LUCKSKY Fungal Nail RenewalUNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.57a73b60-bbac-97e6-e063-6294a90ab9a92026-07-28WarningsExact identifier
unii: K3D86KJ24N
Ponamfo ANTIFUNGAL TREATMENT PENUNDECYLENICGuangzhou Bixiaoyu Trading Co., Ltd.57a9ccff-270b-9769-e063-6394a90a5e0c2026-07-28WarningsExact identifier
unii: K3D86KJ24N
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsExact identifier
unii: K3D86KJ24N
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
unii: K3D86KJ24N
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WR1WPI7EW8
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
unii: WR1WPI7EW8
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
unii: K3D86KJ24N
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact identifier
unii: K3D86KJ24N
HTRCSW FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523bc484-511c-b603-e063-6394a90a55ae2026-07-21WarningsExact identifier
unii: K3D86KJ24N
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dimethyl SulfoxideDIMETHYL SULFOXIDERenova Pharmaceuticals LLC8f699de6-9d09-48da-9d95-4001d70085872026-07-20Warnings, Adverse reactionsExact identifier
unii: YOW8V9698H
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)Jiangxi Yudexi Pharmaceutical Co., LTD51eb8766-cc94-360d-e063-6294a90a69532026-07-20WarningsExact identifier
unii: K3D86KJ24N
AVENASTER FUNGAL NAIL CARE DUO SET (DAY)UREA 20% FUNGAL NAIL CARE DUO SET (DAY)Jiangxi Yudexi Pharmaceutical Co., LTD51ebecc4-391c-ff08-e063-6294a90a20ed2026-07-20WarningsExact identifier
unii: 8W8T17847W

Reported adverse events (FAERS/openFDA)#

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