Fluocinonide

Product NDC: 70700-146
11-digit product format: 707000146
Labeler code: 70700
Product ID: 70700-146_2bfc0a7d-82bb-11d0-8ea7-c2d2a9c836ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Xiromed LLC
Application: ANDA212976
Marketing category: ANDA
Marketing start: 2019-12-09
Substance: FLUOCINONIDE
Active strength: .05 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 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
A212976-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB		2019-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212976-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212976-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212976-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212976-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212976-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212976-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212976-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212976-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212976-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212976-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212976-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212976-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212976-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212976-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212976-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212976-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212976-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212976-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212976-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212976-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212976-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212976-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212976-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212976-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212976-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212976-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212976-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212976-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212976-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212976-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212976-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212976-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212976-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212976-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212976-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212976-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212976-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212976-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212976-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINONIDE	.05 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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70700-146-15	Fluocinonide	15 g in 1 TUBE	OINTMENT	15	8
70700-146-15	Fluocinonide	1 in 1 CARTON	OINTMENT	1	8
70700-146-16	Fluocinonide	1 in 1 CARTON	OINTMENT	1	8
70700-146-16	Fluocinonide	30 g in 1 TUBE	OINTMENT	30	8
70700-146-17	Fluocinonide	1 in 1 CARTON	OINTMENT	1	8
70700-146-17	Fluocinonide	60 g in 1 TUBE	OINTMENT	60	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70700-146-15	GM - Gram	70700-146	ceccf47b-19f4-4064-bbe7-0f9b8be1ddb6	1	2020-09-14
70700-146-16	GM - Gram	70700-146	dd8f51d9-4352-430b-85b5-2ca6be51bcf5	1	2020-09-14
70700-146-17	GM - Gram	70700-146	99245cd3-9ea6-47a9-80ff-e6f4f3fc94d0	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70700-146	FLUOCINONIDE (FLUOCINONIDE ) OINTMENT [XIROMED LLC]	8	Current NDC, Legacy NDC, 6 package rows	20230707_d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	9bad56f2-6070-44fc-a39d-bb00280057f0	2026-06-01	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	4fbb3f39-c856-4da6-90b1-a6749de892c5	2024-01-10	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	9ee44ed9-e274-4673-8829-0032a36e5b79	2024-01-10	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	0a1dab63-17d0-4ae7-890b-7746be65e29b	2024-01-10	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976
Fluocinonide	FLUOCINONIDE	Xiromed LLC	d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc	2020-01-13	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976 ndc (product): 70700-146

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2W4A77YPAN	FLUOCINONIDE	356-12-7	FLUOCINONIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70700-146-15	70700014615	1 TUBE in 1 CARTON (70700-146-15) / 15 g in 1 TUBE	1 tube	2019-12-09	0000-00-00	No	No	Current
70700-146-16	70700014616	1 TUBE in 1 CARTON (70700-146-16) / 30 g in 1 TUBE	1 tube	2019-12-09	0000-00-00	No	No	Current
70700-146-17	70700014617	1 TUBE in 1 CARTON (70700-146-17) / 60 g in 1 TUBE	1 tube	2019-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Ointment, 0.05%	Bryant Ranch Prepack	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	104
Fluocinonide Ointment, 0.05%	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
Fluocinonide Ointment, 0.05%	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
Fluocinonide Ointment, 0.05%	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
Fluocinonide Ointment, 0.05%	Xiromed LLC \| Xiromed Pharma España, S.L \| Laboratorios Liconsa SAU	2020-01-13	HUMAN PRESCRIPTION DRUG LABEL	8