Fluocinolone Acetonide

Product NDC: 62559-299
11-digit product format: 625590299
Labeler code: 62559
Product ID: 62559-299_ef1837eb-defb-4edd-a11c-824a890d5a95
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinolone Acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA013960
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-11-13
Substance: FLUOCINOLONE ACETONIDE
Active strength: .25 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N013960-001	SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N013960-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013960-001	SYNALAR	0.025%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013960-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013960-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013960-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013960-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013960-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013960-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013960-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013960-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013960-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013960-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013960-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013960-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013960-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013960-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013960-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013960-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013960-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013960-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013960-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013960-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013960-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013960-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013960-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013960-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013960-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013960-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013960-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013960-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013960-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013960-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013960-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013960-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013960-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013960-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013960-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013960-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013960-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013960-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N013960-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013960-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluocinolone Acetonide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINOLONE ACETONIDE	.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0CD5FD6S2M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191256	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
622c9804-0be0-4dec-a6ba-5cf4b5578a84	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0adb2af5-1ecf-4df5-912b-16ae89228294	Product name	6	20240829
65f6255d-41cc-425f-ba54-b1bea4947886	Product name	5	20210930
5ba208e4-886f-44da-e218-ab4f4cad2c49	Product name	5	20190612
e5a2793f-318b-72fd-b734-c44ecc6f6748	Product name	2	20190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
7df2570a-c555-4d82-9189-9247c722b62c	Product name	1	20150402
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
a78a3633-fd06-b0af-63b3-c714de3b3bfa	Product name	1	20140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62559-299-15	Fluocinolone Acetonide	1 in 1 CARTON	OINTMENT	1	2
62559-299-15	Fluocinolone Acetonide	15 g in 1 TUBE	OINTMENT	15	2
62559-299-60	Fluocinolone Acetonide	60 g in 1 TUBE	OINTMENT	60	2
62559-299-60	Fluocinolone Acetonide	1 in 1 CARTON	OINTMENT	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-299-15	GM - Gram	62559-299	baa4d5bf-5a09-45b4-a037-72115df32b75	1	2023-12-05
62559-299-60	GM - Gram	62559-299	367ed4c6-e55b-47e0-ab69-c619e68ebecb	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-299	FLUOCINOLONE ACETONIDE OINTMENT [ANI PHARMACEUTICALS, INC.]	1	Current NDC, 4 package rows	20231117_622c9804-0be0-4dec-a6ba-5cf4b5578a84.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	622c9804-0be0-4dec-a6ba-5cf4b5578a84	2026-02-23	Adverse reactions	Exact identifier application applno (NDA): 013960 application number: NDA013960 ndc (product): 62559-299
Synalar	FLUOCINOLONE ACETONIDE	Medimetriks Pharmaceuticals, Inc.	d2d155cf-a635-4ab7-87de-34e90b9a74cd	2023-11-29	Adverse reactions	Exact identifier application applno (NDA): 013960 application number: NDA013960

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0CD5FD6S2M	FLUOCINOLONE ACETONIDE	67-73-2	FLUOCINOLONE ACETONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1191256	fluocinolone acetonide 0.025 % Topical Ointment	PSN	622c9804-0be0-4dec-a6ba-5cf4b5578a84	2
1191256	fluocinolone acetonide 0.00025 MG/MG Topical Ointment	SCD	622c9804-0be0-4dec-a6ba-5cf4b5578a84	2
1191256	fluocinolone acetonide 0.025 % Topical Ointment	SY	622c9804-0be0-4dec-a6ba-5cf4b5578a84	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62559-299-15	62559029915	1 TUBE in 1 CARTON (62559-299-15) / 15 g in 1 TUBE	1 tube	2023-11-16	No	No	Current
62559-299-60	62559029960	1 TUBE in 1 CARTON (62559-299-60) / 60 g in 1 TUBE	1 tube	2023-11-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinolone Acetonide Ointment USP, 0.025% Rx Only	ANI Pharmaceuticals, Inc.	2026-02-23	HUMAN PRESCRIPTION DRUG LABEL	2