FDA.reportPublic FDA data

Fiore Rx Coral Sorbet Antifungal Nail Polish

Product NDC
52261-0207
11-digit product format
522610207
Labeler code
52261
Product ID
52261-0207_3c3e09f1-2aa8-4bf7-b4dc-8af16d0e3759
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid
Dosage form
FILM
Route
TOPICAL
Labeler
Cosco International, Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-05-22
Marketing end
0000-00-00
Substance
UNDECYLENIC ACID
Active strength
0 g/15mL
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
52261-0207-02020-01-31C16284748780-19d75b9d0-0034-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0207-0Fiore Rx Coral Sorbet Antifungal Nail Polish15 mL in 1 BOTTLE, WITH APPLICATORFILM152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Undecylenic AcidACTIVE INGREDIENTK3D86KJ24NFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
Undecylenic AcidACTIVE MOIETYK3D86KJ24NFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
Acetyltributyl CitrateINACTIVE INGREDIENT0ZBX0N59RZFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
BENTOQUATAMINACTIVE INGREDIENT7F465U79Q1FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
BenzoresorcinolINACTIVE INGREDIENTLJ54R4Z029FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
Butyl AcetateINACTIVE INGREDIENT464P5N1905FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
Ethyl AcetateINACTIVE INGREDIENT76845O8NMZFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
PolacrilinINACTIVE INGREDIENTRCZ785HI7SFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
POLYESTER-10INACTIVE INGREDIENT212N9O2MMZFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOFFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
PyroxylinINACTIVE INGREDIENTKYR8BR2X6OFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2
Trimethylpentanediyl DibenzoateINACTIVE INGREDIENTY8PB83G67AFIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0207FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]2Legacy NDC, 1 package rows20130919_516e190d-2d88-433e-ac47-8ad6e1bc0c99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437982Fiore Rx Antifungal 3 % Nail PolishPSN516e190d-2d88-433e-ac47-8ad6e1bc0c992
1437977Undecylenic Acid 3 % Topical SolutionPSN516e190d-2d88-433e-ac47-8ad6e1bc0c992
1437982undecylenic acid 30 MG/ML Topical Solution [Fiore]SBD516e190d-2d88-433e-ac47-8ad6e1bc0c992
1437977undecylenic acid 30 MG/ML Topical SolutionSCD516e190d-2d88-433e-ac47-8ad6e1bc0c992
1437982Fiore 30 MG/ML Topical SolutionSY516e190d-2d88-433e-ac47-8ad6e1bc0c992
1437982Fiore Rx 3 % Nail PolishSY516e190d-2d88-433e-ac47-8ad6e1bc0c992
1437977Undecylenic Acid 3 % Topical SolutionSY516e190d-2d88-433e-ac47-8ad6e1bc0c992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52261-0207-05226102070015 mL in 1 BOTTLE, WITH APPLICATOR15 mlHistorical