Fluocinonide Cream

Product NDC: 69238-1534
11-digit product format: 692381534
Labeler code: 69238
Product ID: 69238-1534_64167760-d963-439f-ac85-21eefb5e8b39
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA210554
Marketing category: ANDA
Marketing start: 2017-10-01
Substance: FLUOCINONIDE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A210554-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210554-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210554-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210554-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210554-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210554-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210554-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210554-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210554-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210554-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210554-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210554-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210554-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210554-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210554-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210554-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210554-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210554-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210554-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210554-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210554-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210554-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210554-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210554-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210554-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210554-001	AB1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210554-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210554-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210554-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210554-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210554-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210554-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210554-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210554-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210554-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210554-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210554-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210554-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210554-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210554-001	AB1	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluocinonide Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINONIDE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2W4A77YPAN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103456	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
817cac6b-fec5-406d-aa0c-8852d08a3c65	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
a338afdd-91bc-4c45-5113-8b445b8e6cf2	Product name	5	20200618
f3bf4e6e-291f-4372-8e90-b4047949153a	Product name	3	20200514
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69238-1534-2	Fluocinonide Cream	120 g in 1 TUBE	CREAM	120	8
69238-1534-2	Fluocinonide Cream	1 in 1 CARTON	CREAM	1	8
69238-1534-3	Fluocinonide Cream	1 in 1 CARTON	CREAM	1	8
69238-1534-3	Fluocinonide Cream	30 g in 1 TUBE	CREAM	30	8
69238-1534-5	Fluocinonide Cream	15 g in 1 TUBE	CREAM	15	8
69238-1534-5	Fluocinonide Cream	1 in 1 CARTON	CREAM	1	8
69238-1534-6	Fluocinonide Cream	60 g in 1 TUBE	CREAM	60	8
69238-1534-6	Fluocinonide Cream	1 in 1 CARTON	CREAM	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1534-2	GM - Gram	69238-1534	99939f19-b2b3-4970-82a0-f3b9f9bf38f7	1	2021-08-05
69238-1534-3	GM - Gram	69238-1534	ee745d46-0de1-4815-934d-0fc80b15409a	1	2021-08-05
69238-1534-5	GM - Gram	69238-1534	56955223-56e7-4d87-9fb8-97608622f2dd	1	2021-08-05
69238-1534-6	GM - Gram	69238-1534	51a259ca-6a92-447f-a5ee-b25314f28556	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1534	FLUOCINONIDE CREAM (FLUOCINONIDE) CREAM [AMNEAL PHARMACEUTICALS NY LLC]	8	Current NDC, Legacy NDC, 8 package rows	20240404_817cac6b-fec5-406d-aa0c-8852d08a3c65.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ab79df76-192b-422e-8d2c-dd5a46ffb216	2026-03-06	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	b1b4a6e9-814e-41e9-9f35-8bed7595265b	2026-02-08	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554
Fluocinonide Cream	FLUOCINONIDE	Amneal Pharmaceuticals NY LLC	817cac6b-fec5-406d-aa0c-8852d08a3c65	2023-06-06	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554 ndc (product): 69238-1534

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	817cac6b-fec5-406d-aa0c-8852d08a3c65	8
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	817cac6b-fec5-406d-aa0c-8852d08a3c65	8
103456	fluocinonide 0.05 % Topical Cream	SY	817cac6b-fec5-406d-aa0c-8852d08a3c65	8
103456	fluocinonide 0.05 % Topical Cream	PSN	b1b4a6e9-814e-41e9-9f35-8bed7595265b	4
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	b1b4a6e9-814e-41e9-9f35-8bed7595265b	4
103456	fluocinonide 0.05 % Topical Cream	SY	b1b4a6e9-814e-41e9-9f35-8bed7595265b	4
103456	fluocinonide 0.05 % Topical Cream	PSN	ab79df76-192b-422e-8d2c-dd5a46ffb216	2
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	ab79df76-192b-422e-8d2c-dd5a46ffb216	2
103456	fluocinonide 0.05 % Topical Cream	SY	ab79df76-192b-422e-8d2c-dd5a46ffb216	2
103456	fluocinonide 0.05 % Topical Cream	PSN	db86f8bd-1537-f6dd-e053-2a95a90a672e	1
103456	fluocinonide 0.05 % Topical Cream	PSN	e5bf009d-b80b-60f3-e053-2995a90a6d66	1
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	db86f8bd-1537-f6dd-e053-2a95a90a672e	1
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	e5bf009d-b80b-60f3-e053-2995a90a6d66	1
103456	fluocinonide 0.05 % Topical Cream	SY	db86f8bd-1537-f6dd-e053-2a95a90a672e	1
103456	fluocinonide 0.05 % Topical Cream	SY	e5bf009d-b80b-60f3-e053-2995a90a6d66	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1534-2	69238153402	1 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBE	1 tube	2017-10-01	0000-00-00	No	No	Current
69238-1534-3	69238153403	1 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBE	1 tube	2017-10-01	0000-00-00	No	No	Current
69238-1534-5	69238153405	1 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBE	1 tube	2017-10-01	0000-00-00	No	No	Current
69238-1534-6	69238153406	1 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBE	1 tube	2017-10-01	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	A-S Medication Solutions	2026-03-06	HUMAN PRESCRIPTION DRUG LABEL	2
Fluocinonide Cream USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only	A-S Medication Solutions	2026-02-08	HUMAN PRESCRIPTION DRUG LABEL	4
Fluocinonide Cream	Preferred Pharmaceuticals Inc.	2025-05-13	HUMAN PRESCRIPTION DRUG LABEL	5
Fluocinonide Cream	Amneal Pharmaceuticals NY LLC	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL	8
Fluocinonide Cream	NuCare Pharmaceuticals,Inc. \| NuCare Pharmacetuicals,Inc.	2022-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
Fluocinonide Cream	NuCare Pharmceuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2022-03-31	HUMAN PRESCRIPTION DRUG LABEL	1