Fluocinolone Acetonide

Product NDC: 52565-031
Requested package NDC: 52565-031-15
11-digit product format: 525650031
Labeler code: 52565
Product ID: 52565-031_cc078a70-6715-4610-8eed-bd20ac4062a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinolone Acetonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: NDA012787
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-05-15
Marketing end: 0000-00-00
Substance: FLUOCINOLONE ACETONIDE
Active strength: 0 mg/g
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	52565-031	52565-031-15	I	Inactivated by FDA		2026-08-10

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 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N012787-002	SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
N012787-004	SYNALAR	FLUOCINOLONE ACETONIDE	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
N012787-005	SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N012787-002	AT
N012787-004	AT
N012787-005	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 4 · 123 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	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N012787-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-004	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-005	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-004	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-005	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012787-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-004	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-005	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-004	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-005	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-004	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-005	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-004	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-005	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-004	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-005	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-004	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-005	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-004	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-005	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012787-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-004	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-005	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-004	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-005	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-004	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-005	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-004	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-005	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012787-002	AT	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-031-15	2022-01-28	C162847	48780-1	d6a99b39-8346-a426-e053-dadaa90af4c2	Fluocinolone Acetonide Cream USP, 0.01%, 0.025%
52565-031-60	2022-01-28	C162847	48780-1	d6a99b39-8346-a426-e053-dadaa90af4c2	Fluocinolone Acetonide Cream USP, 0.01%, 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-031-15	Fluocinolone Acetonide	1 in 1 CARTON	CREAM	1	4
52565-031-15	Fluocinolone Acetonide	15 g in 1 TUBE	CREAM	15	4
52565-031-60	Fluocinolone Acetonide	60 g in 1 TUBE	CREAM	60	4
52565-031-60	Fluocinolone Acetonide	1 in 1 CARTON	CREAM	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-031-15	GM - Gram	52565-031	e8a2811d-cc19-4354-ac68-6e99a5447a6b	1	2014-06-03
52565-031-60	GM - Gram	52565-031	769f202b-4647-48a6-9693-985fffa4dbbb	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluocinolone Acetonide	ACTIVE INGREDIENT	0CD5FD6S2M	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Fluocinolone Acetonide	ACTIVE MOIETY	0CD5FD6S2M	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Cyclomethicone 4	INACTIVE INGREDIENT	CZ227117JE	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Polyoxyl 20 Cetostearyl Ether	INACTIVE INGREDIENT	YRC528SWUY	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2
White Wax	INACTIVE INGREDIENT	7G1J5DA97F	FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-031	FLUOCINOLONE ACETONIDE CREAM [TELIGENT PHARMA, INC.]	4	Legacy NDC, 4 package rows	20181017_da65dffd-a017-46dd-8a5b-a4e4574c4abc.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.	50e7006d-a51b-49aa-8e1c-330340e7bf82	2026-02-23	Adverse reactions	Exact identifier application applno (NDA): 012787 application number: NDA012787
Synalar	FLUOCINOLONE ACETONIDE	Medimetriks Pharmaceuticals, Inc.	5af2e4c1-082b-48a0-aae7-72d4a68cbb2d	2024-07-18	Adverse reactions	Exact identifier application applno (NDA): 012787 application number: NDA012787

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
1191302	fluocinolone acetonide 0.01 % Topical Cream	PSN	da65dffd-a017-46dd-8a5b-a4e4574c4abc	4
1191315	fluocinolone acetonide 0.025 % Topical Cream	PSN	da65dffd-a017-46dd-8a5b-a4e4574c4abc	4
1191302	fluocinolone acetonide 0.1 MG/ML Topical Cream	SCD	da65dffd-a017-46dd-8a5b-a4e4574c4abc	4
1191315	fluocinolone acetonide 0.25 MG/ML Topical Cream	SCD	da65dffd-a017-46dd-8a5b-a4e4574c4abc	4
1191302	fluocinolone acetonide 0.01 % Topical Cream	SY	da65dffd-a017-46dd-8a5b-a4e4574c4abc	4
1191315	fluocinolone acetonide 0.025 % Topical Cream	SY	da65dffd-a017-46dd-8a5b-a4e4574c4abc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-031-15	52565003115	1 TUBE in 1 CARTON (52565-031-15) > 15 g in 1 TUBE	1 tube	2014-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinolone Acetonide Cream USP, 0.01%, 0.025%	Teligent Pharma, Inc.	2014-05-07	HUMAN PRESCRIPTION DRUG LABEL	4