Topicort

Product NDC: 51672-5203
11-digit product format: 516725203
Labeler code: 51672
Product ID: 51672-5203_f42ec0f5-b9db-4cc1-b466-4ff4869d8a8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desoximetasone
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA074286
Marketing category: ANDA
Marketing start: 1992-12-15
Marketing end: 0000-00-00
Substance: DESOXIMETASONE
Active strength: 3 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-5203		I	Inactivated by FDA	2026-08-17
excluded package	package	51672-5203	51672-5203-1	I	Inactivated by FDA	2026-08-17
excluded package	package	51672-5203	51672-5203-3	I	Inactivated by FDA	2026-08-17
excluded package	package	51672-5203	51672-5203-5	I	Inactivated by FDA	2026-08-17
excluded package	package	51672-5203	51672-5203-7	I	Inactivated by FDA	2026-08-17

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 · 10 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	51672-5203-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-5203-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-5203-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-5203-1	`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	51672-5203-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-5203-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-5203-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-5203-1	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A074286-001	TOPICORT	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL			1996-06-07

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	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL	AB	RS	1996-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074286-001	TOPICORT	0.25%	OINTMENT / TOPICAL			1996-06-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074286-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074286-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074286-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074286-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074286-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074286-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074286-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074286-001	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83e6065d-d4c9-f323-882e-7de38bb4d6ac	Product name	9	20200701
7b3bb32e-bbfd-11d9-a253-bc78b5f7d7be	Product name	3	20190204
08e04f33-a0f6-279a-7d07-56df7c40d693	Product name	3	20180605
d67f22fb-500c-d680-0b1d-d0de623f55e7	Product name	7	20171113

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51672-5203-1	Topicort ® (Desoximetasone Ointment USP) 0.25%
51672-5203-3	Topicort ® (Desoximetasone Ointment USP) 0.25%
51672-5203-5	Topicort ® (Desoximetasone Ointment USP) 0.25%
51672-5203-7	Topicort ® (Desoximetasone Ointment USP) 0.25%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-5203-1	Topicort	15 g in 1 TUBE	OINTMENT	15	5
51672-5203-1	Topicort	1 in 1 CARTON	OINTMENT	1	5
51672-5203-3	Topicort	60 g in 1 TUBE	OINTMENT	60	5
51672-5203-3	Topicort	1 in 1 CARTON	OINTMENT	1	5
51672-5203-5	Topicort	5 g in 1 TUBE	OINTMENT	5	5
51672-5203-7	Topicort	1 in 1 CARTON	OINTMENT	1	5
51672-5203-7	Topicort	100 g in 1 TUBE	OINTMENT	100	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-5203-1	GM - Gram	51672-5203	aafe18e5-410d-410f-8d09-57715d0e08c9	1	2012-07-24
51672-5203-3	GM - Gram	51672-5203	a51347b4-8b17-4fb9-95dd-199bd9f8a204	1	2012-07-24
51672-5203-7	GM - Gram	51672-5203	85a5781f-7997-461f-92af-da9c4ab17d50	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
desoximetasone	ACTIVE INGREDIENT	4E07GXB7AU	TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]	3
desoximetasone	ACTIVE MOIETY	4E07GXB7AU	TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]	3
coconut oil	INACTIVE INGREDIENT	Q9L0O73W7L	TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]	3
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-5203	TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]	5	Legacy NDC, 7 package rows	20190308_612e53ec-720c-47ba-97bc-5db85064e33b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desoximetasone	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	627031fc-9b91-4854-b08f-f9fc0c73f1de	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074286 application number: ANDA074286

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4E07GXB7AU	DESOXIMETASONE	382-67-2	DESOXIMETASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197575	desoximetasone 0.25 % Topical Ointment	PSN	612e53ec-720c-47ba-97bc-5db85064e33b	5
94348	Topicort 0.25 % Topical Ointment	PSN	612e53ec-720c-47ba-97bc-5db85064e33b	5
94348	desoximetasone 0.0025 MG/MG Topical Ointment [Topicort]	SBD	612e53ec-720c-47ba-97bc-5db85064e33b	5
197575	desoximetasone 0.0025 MG/MG Topical Ointment	SCD	612e53ec-720c-47ba-97bc-5db85064e33b	5
197575	desoximetasone 0.25 % Topical Ointment	SY	612e53ec-720c-47ba-97bc-5db85064e33b	5
94348	Topicort 0.0025 MG/MG Topical Ointment	SY	612e53ec-720c-47ba-97bc-5db85064e33b	5
94348	Topicort 0.25 % Topical Ointment	SY	612e53ec-720c-47ba-97bc-5db85064e33b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-5203-1	51672520301	1 TUBE in 1 CARTON (51672-5203-1) > 15 g in 1 TUBE	1 tube	1992-12-15	0000-00-00	No	No	Current
51672-5203-3	51672520303	1 TUBE in 1 CARTON (51672-5203-3) > 60 g in 1 TUBE	1 tube	1992-12-15	0000-00-00	No	No	Current
51672-5203-5	51672520305	5 g in 1 TUBE (51672-5203-5)	5 g	1992-12-15	0000-00-00	No	No	Current
51672-5203-7	51672520307	1 TUBE in 1 CARTON (51672-5203-7) > 100 g in 1 TUBE	1 tube	1992-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topicort ® (Desoximetasone Ointment USP) 0.25%	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceuticals Inc.	2019-03-06	HUMAN PRESCRIPTION DRUG LABEL	5