Fluocinonide

Product NDC: 52565-025
Requested package NDC: 52565-025-59
11-digit product format: 525650025
Labeler code: 52565
Product ID: 52565-025_c95f0c00-d292-4b5b-a7f1-f7478bbfb94c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluocinonide
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA207554
Marketing category: ANDA
Marketing start: 2019-03-18
Marketing end: 0000-00-00
Substance: FLUOCINONIDE
Active strength: 1 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	52565-025	52565-025-59	I	Inactivated by FDA		2026-10-05

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207554-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT		2019-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207554-001	AT

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 · 43 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
2026-09-14 22:38:34	2026-08	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL		2019-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207554-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2019-03-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207554-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207554-001	AT	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207554-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207554-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207554-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207554-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207554-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207554-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207554-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207554-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207554-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207554-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207554-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207554-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207554-001	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A207554-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207554-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207554-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207554-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207554-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207554-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207554-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-025-20	2023-01-30	C162847	48780-1	f386c64a-0906-0266-e053-dadaa90a7c1a	Fluocinonide Topical Solution USP, 0.05%
52565-025-59	2023-01-30	C162847	48780-1	f386c64a-0906-0266-e053-dadaa90a7c1a	Fluocinonide Topical Solution USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-025-20	Fluocinonide	1 in 1 CARTON	SOLUTION	1	4
52565-025-20	Fluocinonide	20 mL in 1 BOTTLE	SOLUTION	20	4
52565-025-59	Fluocinonide	60 mL in 1 BOTTLE	SOLUTION	60	4
52565-025-59	Fluocinonide	1 in 1 CARTON	SOLUTION	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-025-20	ML - Milliliter	52565-025	c118f0f2-1aa6-4968-afdd-2f50f3fc1e41	1	2019-06-19
52565-025-59	ML - Milliliter	52565-025	165ccd31-2f86-4d14-aed5-c78294ea3920	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-025	FLUOCINONIDE SOLUTION [TELIGENT PHARMA, INC.]	4	Legacy NDC, 4 package rows	20190911_edd2e419-44b0-4b7b-9037-d5cbd5d3b63c.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Saptalis Pharmaceuticals, LLC.	20f8e9a2-a63d-4bee-bc14-b9f04087d87b	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 207554 application number: ANDA207554

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
310364	fluocinonide 0.05 % Topical Solution	PSN	edd2e419-44b0-4b7b-9037-d5cbd5d3b63c	4
310364	fluocinonide 0.5 MG/ML Topical Solution	SCD	edd2e419-44b0-4b7b-9037-d5cbd5d3b63c	4
310364	fluocinonide 0.05 % Topical Solution	SY	edd2e419-44b0-4b7b-9037-d5cbd5d3b63c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-025-59	52565002559	1 BOTTLE in 1 CARTON (52565-025-59) > 60 mL in 1 BOTTLE	1 bottle	2019-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Topical Solution USP, 0.05%	Teligent Pharma, Inc.	2016-08-24	HUMAN PRESCRIPTION DRUG LABEL	4