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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52261-0207		I	Inactivated by FDA		2026-08-17
excluded package	package	52261-0207	52261-0207-0	I	Inactivated by FDA		2026-08-17

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52261-0207-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52261-0207-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52261-0207-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52261-0207-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52261-0207-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52261-0207-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52261-0207-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52261-0207-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52261-0207-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52261-0207-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52261-0207-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52261-0207-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52261-0207-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52261-0207-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52261-0207-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52261-0207-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52261-0207-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52261-0207-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52261-0207-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52261-0207-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52261-0207-0	`9bebd1f3094a…`	`5416666fcb17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52261-0207-0	2020-01-31	C162847	48780-1	9d75b9d0-0034-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52261-0207-0	Fiore Rx Coral Sorbet Antifungal Nail Polish	15 mL in 1 BOTTLE, WITH APPLICATOR	FILM	15		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Undecylenic Acid	ACTIVE INGREDIENT	K3D86KJ24N	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Undecylenic Acid	ACTIVE MOIETY	K3D86KJ24N	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Acetyltributyl Citrate	INACTIVE INGREDIENT	0ZBX0N59RZ	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
BENTOQUATAM	INACTIVE INGREDIENT	7F465U79Q1	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Benzoresorcinol	INACTIVE INGREDIENT	LJ54R4Z029	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Butyl Acetate	INACTIVE INGREDIENT	464P5N1905	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	905HNO1SIH	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Ethyl Acetate	INACTIVE INGREDIENT	76845O8NMZ	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Polacrilin	INACTIVE INGREDIENT	RCZ785HI7S	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
POLYESTER-10	INACTIVE INGREDIENT	212N9O2MMZ	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Pyroxylin	INACTIVE INGREDIENT	KYR8BR2X6O	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2
Trimethylpentanediyl Dibenzoate	INACTIVE INGREDIENT	Y8PB83G67A	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52261-0207	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2	Legacy NDC, 1 package rows	20130919_516e190d-2d88-433e-ac47-8ad6e1bc0c99.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K3D86KJ24N	UNDECYLENIC ACID	112-38-9	UNDECYLENIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1437982	Fiore Rx Antifungal 3 % Nail Polish	PSN	516e190d-2d88-433e-ac47-8ad6e1bc0c99	2
1437977	Undecylenic Acid 3 % Topical Solution	PSN	516e190d-2d88-433e-ac47-8ad6e1bc0c99	2
1437982	undecylenic acid 30 MG/ML Topical Solution [Fiore]	SBD	516e190d-2d88-433e-ac47-8ad6e1bc0c99	2
1437977	undecylenic acid 30 MG/ML Topical Solution	SCD	516e190d-2d88-433e-ac47-8ad6e1bc0c99	2
1437982	Fiore 30 MG/ML Topical Solution	SY	516e190d-2d88-433e-ac47-8ad6e1bc0c99	2
1437982	Fiore Rx 3 % Nail Polish	SY	516e190d-2d88-433e-ac47-8ad6e1bc0c99	2
1437977	Undecylenic Acid 3 % Topical Solution	SY	516e190d-2d88-433e-ac47-8ad6e1bc0c99	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52261-0207-0	52261020700	15 mL in 1 BOTTLE, WITH APPLICATOR	15 ml	Historical