Fluocinolone Acetonide

Product NDC: 0713-0324
11-digit product format: 007130324
Labeler code: 0713
Product ID: 0713-0324_c10fc756-20e4-4b3b-8673-9b8af3f39eee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinolone Acetonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Cosette Pharmaceuticals, Inc.
Application: NDA012787
Marketing category: NDA
Marketing start: 2013-12-20
Marketing end: 2020-09-30
Substance: FLUOCINOLONE ACETONIDE
Active strength: 0 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0713-0324		D	Discontinued by firm	2026-08-03
excluded package	package	0713-0324	0713-0324-15	D	Discontinued by firm	2026-08-03
excluded package	package	0713-0324	0713-0324-60	D	Discontinued by firm	2026-08-03

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 · 36 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	0713-0324-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0713-0324-15	`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	0713-0324-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0713-0324-15	`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	0713-0324-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0713-0324-15	`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	0713-0324-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0713-0324-15	`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	0713-0324-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0713-0324-15	`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	0713-0324-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0713-0324-15	`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	0713-0324-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0713-0324-15	`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	0713-0324-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0713-0324-15	`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	0713-0324-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0713-0324-15	`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	0713-0324-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0713-0324-15	`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	0713-0324-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0713-0324-15	`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	0713-0324-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0713-0324-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluocinolone Acetonide	ACTIVE INGREDIENT	0CD5FD6S2M	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Fluocinolone Acetonide	ACTIVE MOIETY	0CD5FD6S2M	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Polyoxyl 20 Cetostearyl Ether	INACTIVE INGREDIENT	YRC528SWUY	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3
White Wax	INACTIVE INGREDIENT	7G1J5DA97F	FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]	3

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinolone Acetonide Cream USP, 0.025% Rx Only	Cosette Pharmaceuticals, Inc. \| Teligent Pharma, Inc.	2019-08-01	HUMAN PRESCRIPTION DRUG LABEL	5