FDA.reportPublic FDA data

NDC 52261-2500-0 - Fiore Rx Antifungal ProPen

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
52261-2500
Requested NDC
52261-2500-0
Package NDCs from labels
52261-2500-0, 52261-2500-1
Manufacturer
Cosco International, Inc.
Effective date
2013-09-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsCosco International, Inc.2013-09-19HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-2500-12020-01-31C16284748780-19d75b9d1-07a7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-2500-0Fiore Rx Antifungal ProPen2 g in 1 TUBE, WITH APPLICATORLIQUID22
52261-2500-1Fiore Rx Antifungal ProPen1 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-2500FIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2Legacy NDC, 2 package rows20130924_5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Undecylenic AcidACTIVE INGREDIENTK3D86KJ24NFIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
Undecylenic AcidACTIVE MOIETYK3D86KJ24NFIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0FIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1FIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KFIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOFFIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISFIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
SIMMONDSIA CHINENSIS SEEDINACTIVE INGREDIENTD24K2Q1F6HFIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2
SUNFLOWER SEEDINACTIVE INGREDIENTR9N3379M4ZFIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]2

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 3 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
unii: K3D86KJ24N
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
unii: K3D86KJ24N
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
unii: K3D86KJ24N
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
unii: K3D86KJ24N
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
unii: K3D86KJ24N
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
unii: K3D86KJ24N
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
unii: K3D86KJ24N
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
unii: K3D86KJ24N
YEARCHOICE Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.5500b582-0641-498d-e063-6394a90a3c582026-06-24WarningsExact identifier
unii: K3D86KJ24N
VTROUY Fungal Nail Renewal PenFUNGAL NAIL RENEWAL PENGuangzhou Jingliang Cosmetics Co., Ltd.549bf490-99c2-c800-e063-6394a90a672b2026-06-19WarningsExact identifier
unii: K3D86KJ24N
KLIPP FUNGAL NAIL TREATMENTKLIPP FUNGAL NAIL TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f2fbe-a2de-057d-e063-6394a90ac7422026-06-17WarningsExact identifier
unii: K3D86KJ24N
WKPIKI FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.54472c44-93de-d4b9-e063-6394a90adde12026-06-15WarningsExact identifier
unii: K3D86KJ24N
TOYKNIER MULTI-PURPOSE TREATMENTUNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4f8eb3a3-8f26-50dd-e063-6294a90ad9f82026-06-14WarningsExact identifier
unii: K3D86KJ24N
CYYZROSE ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD527765d4-6988-ed4e-e063-6394a90a2f232026-06-14WarningsExact identifier
unii: K3D86KJ24N
PUVIDA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4a484e3d-d653-2689-e063-6394a90a64ef2026-06-14WarningsExact identifier
unii: K3D86KJ24N
Klipp EXTRA STRENGTH TOENAIL FUNGUS TREATMENTKLIPP EXTRA STRENGTH TOENAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd54430f20-72db-64f7-e063-6394a90a2cc32026-06-14WarningsExact identifier
unii: K3D86KJ24N
Bldaxn FUNGAL NAIL RENEWZLUNDECYLENIC ACID 25% FUNGAL NAIL RENEWZLJiangxi Yudexi Pharmaceutical Co., LTD4993181e-68d5-6b91-e063-6294a90a65ce2026-06-12WarningsExact identifier
unii: K3D86KJ24N
cmojsk TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOLNAFTATE 1% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD524bbb36-df7b-f21a-e063-6394a90ad0f12026-06-12WarningsExact identifier
unii: K3D86KJ24N
BODYKOO NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% NAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD535191e9-dc55-0c60-e063-6394a90a330f2026-06-12WarningsExact identifier
unii: K3D86KJ24N
EVERFERE ANTIFUNGALUNDECYLENIC ACID 10% ZINC UNDECYLENATE 12% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4bc99af7-ea08-8543-e063-6294a90a44cd2026-06-12WarningsExact identifier
unii: K3D86KJ24N

Reported adverse events (FAERS/openFDA)#

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