Desoximetasone

Product NDC: 71656-086
11-digit product format: 716560086
Labeler code: 71656
Product ID: 71656-086_518f7202-620a-0117-e063-6394a90ac9f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desoximetasone
Dosage form: CREAM
Route: TOPICAL
Labeler: Saptalis Pharmaceuticals, LLC.
Application: ANDA203787
Marketing category: ANDA
Marketing start: 2026-04-13
Substance: DESOXIMETASONE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	71656-086		D	Discontinued by firm	2026-08-17
excluded package	package	71656-086	71656-086-15	D	Discontinued by firm	2026-08-17
excluded package	package	71656-086	71656-086-60	D	Discontinued by firm	2026-08-17

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
A203787-001	DESOXIMETASONE	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB		2017-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203787-001	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.

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL	AB	2017-01-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203787-001	DESOXIMETASONE	0.05%	CREAM / TOPICAL		2017-01-06	`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	A203787-001	AB	1	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	A203787-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203787-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203787-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203787-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203787-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203787-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203787-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203787-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203787-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Desoximetasone
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4E07GXB7AU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197573	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
827aee22-cf48-477c-8791-c74f16da954d	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71656-086-15	Desoximetasone	15 g in 1 TUBE	CREAM	15	2
71656-086-15	Desoximetasone	15 in 1 CARTON	CREAM	15	2
71656-086-60	Desoximetasone	60 g in 1 TUBE	CREAM	60	2
71656-086-60	Desoximetasone	60 in 1 CARTON	CREAM	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71656-086-15	GM - Gram	71656-086	8655c7ba-b6f5-40c8-a281-aa1664cf63e0	1	2026-05-22
71656-086-60	GM - Gram	71656-086	59196324-9ab0-4f67-aece-2366c2e81567	1	2026-05-22

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	Saptalis Pharmaceuticals, LLC.	827aee22-cf48-477c-8791-c74f16da954d	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203787 application number: ANDA203787 ndc (product): 71656-086

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
197574	desoximetasone 0.25 % Topical Cream	PSN	c84c7168-3d46-4e05-a25c-3d594ff94268	3
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	c84c7168-3d46-4e05-a25c-3d594ff94268	3
197574	desoximetasone 0.25 % Topical Cream	SY	c84c7168-3d46-4e05-a25c-3d594ff94268	3
197573	desoximetasone 0.05 % Topical Cream	PSN	827aee22-cf48-477c-8791-c74f16da954d	2
197573	desoximetasone 0.5 MG/ML Topical Cream	SCD	827aee22-cf48-477c-8791-c74f16da954d	2
197573	desoximetasone 0.05 % Topical Cream	SY	827aee22-cf48-477c-8791-c74f16da954d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71656-086-15	71656008615	15 TUBE in 1 CARTON (71656-086-15) / 15 g in 1 TUBE	15 tube	2026-04-13	No	No	Current
71656-086-60	71656008660	60 TUBE in 1 CARTON (71656-086-60) / 60 g in 1 TUBE	60 tube	2026-04-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desoximetasone Cream, USP 0.05%	Saptalis Pharmaceuticals, LLC.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	2
Desoximetasone Cream, USP 0.25%	Saptalis Pharmaceuticals, LLC.	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	3