FDA.reportPublic FDA data

Fiore Rx Antifungal ProPen

Product NDC
52261-2500
11-digit product format
522612500
Labeler code
52261
Product ID
52261-2500_08c5d7fd-ce4a-43da-9972-127cef00fe89
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Cosco International, Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-05-21
Marketing end
0000-00-00
Substance
UNDECYLENIC ACID
Active strength
1 g/2g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437982Fiore Rx Antifungal 3 % Nail PolishPSN5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed42
1437977Undecylenic Acid 3 % Topical SolutionPSN5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed42
1437982undecylenic acid 30 MG/ML Topical Solution [Fiore]SBD5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed42
1437977undecylenic acid 30 MG/ML Topical SolutionSCD5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed42
1437982Fiore 30 MG/ML Topical SolutionSY5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed42
1437982Fiore Rx 3 % Nail PolishSY5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed42
1437977Undecylenic Acid 3 % Topical SolutionSY5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52261-2500-0522612500002 g in 1 TUBE, WITH APPLICATOR2 gHistorical
52261-2500-1522612500011 in 1 BOXHistorical