Fiore Rx Rock Candy Clear Antifungal Nail Lacquer

Product NDC
52261-0203
11-digit product format
522610203
Labeler code
52261
Product ID
52261-0203_6e3bcae5-e6bf-4455-ae30-8237138a2cc5
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
2013-05-21
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

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 productproduct52261-0203IInactivated by FDA2026-08-17
excluded packagepackage52261-020352261-0203-0IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52261-0203-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52261-0203-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52261-0203-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52261-0203-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52261-0203-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52261-0203-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52261-0203-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52261-0203-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52261-0203-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52261-0203-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52261-0203-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52261-0203-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52261-0203-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52261-0203-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52261-0203-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52261-0203-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52261-0203-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52261-0203-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52261-0203-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52261-0203-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52261-0203-09bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-0203-02020-01-31C16284748780-19d75b9d1-077a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0203-0Fiore Rx Rock Candy Clear Antifungal Nail Lacquer15 mL in 1 BOTTLE, WITH APPLICATORFILM154

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Undecylenic AcidACTIVE INGREDIENTK3D86KJ24NFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
Undecylenic AcidACTIVE MOIETYK3D86KJ24NFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
Acetyltributyl CitrateINACTIVE INGREDIENT0ZBX0N59RZFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
Butyl AcetateINACTIVE INGREDIENT464P5N1905FIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
D&C Violet No. 2INACTIVE INGREDIENT350KA7O6HKFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
Ethyl AcetateINACTIVE INGREDIENT76845O8NMZFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302FIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
OxybenzoneINACTIVE INGREDIENT95OOS7VE0YFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
POLYESTER-10INACTIVE INGREDIENT212N9O2MMZFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOFFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
PyroxylinINACTIVE INGREDIENTKYR8BR2X6OFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4
Trimethylpentanediyl DibenzoateINACTIVE INGREDIENTY8PB83G67AFIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0203FIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4Legacy NDC, 1 package rows20130919_7faf7a1c-6614-43bc-bef7-36b45d41f8a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437982Fiore Rx Antifungal 3 % Nail PolishPSN7faf7a1c-6614-43bc-bef7-36b45d41f8a44
1437977Undecylenic Acid 3 % Topical SolutionPSN7faf7a1c-6614-43bc-bef7-36b45d41f8a44
1437982undecylenic acid 30 MG/ML Topical Solution [Fiore]SBD7faf7a1c-6614-43bc-bef7-36b45d41f8a44
1437977undecylenic acid 30 MG/ML Topical SolutionSCD7faf7a1c-6614-43bc-bef7-36b45d41f8a44
1437982Fiore 30 MG/ML Topical SolutionSY7faf7a1c-6614-43bc-bef7-36b45d41f8a44
1437982Fiore Rx 3 % Nail PolishSY7faf7a1c-6614-43bc-bef7-36b45d41f8a44
1437977Undecylenic Acid 3 % Topical SolutionSY7faf7a1c-6614-43bc-bef7-36b45d41f8a44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52261-0203-05226102030015 mL in 1 BOTTLE, WITH APPLICATOR15 mlHistorical