Fluocinonide

Product NDC: 51862-494
Requested package NDC: 51862-494-60
11-digit product format: 518620494
Labeler code: 51862
Product ID: 51862-494_ee9c4d1d-f609-74ad-e053-2a95a90ad6d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Mayne Pharma
Application: ANDA073085
Marketing category: ANDA
Marketing start: 2016-10-01
Marketing end: 0000-00-00
Substance: FLUOCINONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51862-494	51862-494-60	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A073085-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		1992-02-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A073085-001	AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A073085-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073085-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073085-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073085-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073085-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073085-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073085-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073085-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073085-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073085-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073085-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073085-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073085-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073085-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073085-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073085-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073085-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073085-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073085-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073085-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073085-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073085-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073085-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073085-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073085-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073085-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073085-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073085-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073085-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073085-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073085-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073085-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073085-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073085-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073085-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073085-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073085-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073085-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073085-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073085-001	AB1	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a338afdd-91bc-4c45-5113-8b445b8e6cf2	Product name	5	20200618
f3bf4e6e-291f-4372-8e90-b4047949153a	Product name	3	20200514
934e8c63-e34a-6dfb-4224-efad2d76fafc	Product name	5	20190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfe	Product name	1	20181219
ef1d202f-16bf-4f17-a390-087db27f5314	Product name	1	20181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29be	Product name	1	20180809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-494-15	GM - Gram	51862-494	f8958951-bfbd-471e-b57d-dc4cc9c5ee89	1	2016-12-07
51862-494-30	GM - Gram	51862-494	48d51a50-27aa-4d57-8784-3c44b4c4542d	1	2016-12-07
51862-494-60	GM - Gram	51862-494	8520606a-dc73-444f-9cb3-4ae63799021b	1	2016-11-08

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Preferred Pharmaceuticals Inc.	f5f39a14-005a-4124-9c00-500598e28012	2026-04-17	Adverse reactions	Exact identifier application applno (ANDA): 073085 application number: ANDA073085
Fluocinonide	FLUOCINONIDE	Cosette Pharmaceuticals, Inc.	e3348b90-8c16-4788-ab61-e354aea5d0a8	2022-12-27	Adverse reactions	Exact identifier application applno (ANDA): 073085 application number: ANDA073085

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2W4A77YPAN	FLUOCINONIDE	356-12-7	FLUOCINONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
103456	fluocinonide 0.05 % Topical Cream	PSN	a61ad82a-1889-4f8a-9627-bc81196cfbc2	5
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	a61ad82a-1889-4f8a-9627-bc81196cfbc2	5
103456	fluocinonide 0.05 % Topical Cream	SY	a61ad82a-1889-4f8a-9627-bc81196cfbc2	5
103456	fluocinonide 0.05 % Topical Cream	PSN	749d0c98-c048-401c-b59e-2de9dc923af1	1
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	749d0c98-c048-401c-b59e-2de9dc923af1	1
103456	fluocinonide 0.05 % Topical Cream	SY	749d0c98-c048-401c-b59e-2de9dc923af1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-494-60	51862049460	1 TUBE in 1 CARTON (51862-494-60) > 60 g in 1 TUBE	1 tube	2016-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUOCINONIDE CREAM, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
FLUOCINONIDE CREAM, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only	Mayne Pharma \| Cosette Pharmaceuticals, Inc. \| Cosette Pharmaceuticals NC Laboratories, LLC	2022-11-29	HUMAN PRESCRIPTION DRUG LABEL	3
Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceuticals, Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	3
Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only	Preferred Pharmaceuticals Inc.	2020-05-27	HUMAN PRESCRIPTION DRUG LABEL	3
Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	3
Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only	NuCare Pharmaceuticals, Inc.	2017-06-12	HUMAN PRESCRIPTION DRUG LABEL	1