Desoximetasone

Product NDC: 45802-495
Requested package NDC: 45802-495-35
11-digit product format: 458020495
Labeler code: 45802
Product ID: 45802-495_00b7b683-69a7-48cc-8286-67288e91c859
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desoximetasone
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA076510
Marketing category: ANDA
Marketing start: 2006-10-24
Substance: DESOXIMETASONE
Active strength: 2.5 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 43.

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
A076510-001	DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB		2003-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076510-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076510-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076510-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076510-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076510-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076510-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076510-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076510-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076510-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076510-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076510-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076510-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076510-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076510-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076510-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076510-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076510-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076510-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076510-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076510-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076510-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076510-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076510-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076510-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076510-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076510-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076510-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076510-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076510-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076510-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076510-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076510-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076510-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076510-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076510-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076510-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076510-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076510-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076510-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076510-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076510-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESOXIMETASONE	2.5 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
197574	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
4ad6c159-4daa-4a33-8db6-351b5263323d	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
45802-495-35	Desoximetasone	15 g in 1 TUBE	CREAM	15	10
45802-495-35	Desoximetasone	1 in 1 CARTON	CREAM	1	10
45802-495-37	Desoximetasone	1 in 1 CARTON	CREAM	1	10
45802-495-37	Desoximetasone	60 g in 1 TUBE	CREAM	60	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-495-35	GM - Gram	45802-495	b20e264f-bef0-40b8-9944-b2c31574be7d	1	2012-07-24
45802-495-37	GM - Gram	45802-495	72794ca0-4f99-46b8-ab85-5111fe195347	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Desoximetasone	ACTIVE INGREDIENT	4E07GXB7AU	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
Desoximetasone	ACTIVE MOIETY	4E07GXB7AU	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
ALUMINUM MONOSTEARATE	INACTIVE INGREDIENT	P9BC99461E	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	DESOXIMETASONE CREAM [PERRIGO NEW YORK INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-495	DESOXIMETASONE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]	10	Current NDC, Legacy NDC, 4 package rows	20250309_4ad6c159-4daa-4a33-8db6-351b5263323d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desoximetasone	DESOXIMETASONE	A-S Medication Solutions	54743c9d-badd-47ce-bf86-6a8c398f7f07	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510
Desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	302fc53a-2779-4168-b76c-9ae0cf0b3331	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510
Desoximetasone	DESOXIMETASONE	Padagis Israel Pharmaceuticals Ltd	4ad6c159-4daa-4a33-8db6-351b5263323d	2025-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510 ndc (package): 45802-495-35 ndc (product): 45802-495 ndc11 (package): 45802049535
Desoximetasone	DESOXIMETASONE	Proficient Rx LP	4f90b0cd-9443-4940-8781-1a05e42ccbb8	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510

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	54743c9d-badd-47ce-bf86-6a8c398f7f07	13
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	54743c9d-badd-47ce-bf86-6a8c398f7f07	13
197574	desoximetasone 0.25 % Topical Cream	SY	54743c9d-badd-47ce-bf86-6a8c398f7f07	13
197574	desoximetasone 0.25 % Topical Cream	PSN	4ad6c159-4daa-4a33-8db6-351b5263323d	10
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	4ad6c159-4daa-4a33-8db6-351b5263323d	10
197574	desoximetasone 0.25 % Topical Cream	SY	4ad6c159-4daa-4a33-8db6-351b5263323d	10
197574	desoximetasone 0.25 % Topical Cream	PSN	4f90b0cd-9443-4940-8781-1a05e42ccbb8	4
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	4f90b0cd-9443-4940-8781-1a05e42ccbb8	4
197574	desoximetasone 0.25 % Topical Cream	SY	4f90b0cd-9443-4940-8781-1a05e42ccbb8	4
197574	desoximetasone 0.25 % Topical Cream	PSN	302fc53a-2779-4168-b76c-9ae0cf0b3331	2
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	302fc53a-2779-4168-b76c-9ae0cf0b3331	2
197574	desoximetasone 0.25 % Topical Cream	SY	302fc53a-2779-4168-b76c-9ae0cf0b3331	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-495-35	45802049535	1 TUBE in 1 CARTON (45802-495-35) / 15 g in 1 TUBE	1 tube	2006-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DESOXIMETASONE CREAM USP, 0.25%	Padagis Israel Pharmaceuticals Ltd	2026-10-06	HUMAN PRESCRIPTION DRUG LABEL	11
DESOXIMETASONE CREAM USP, 0.25%	A-S Medication Solutions	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	13
DESOXIMETASONE CREAM USP, 0.25%	Bryant Ranch Prepack	2025-05-21	HUMAN PRESCRIPTION DRUG LABEL	2
DESOXIMETASONE CREAM USP, 0.25%	Proficient Rx LP	2020-06-01	HUMAN PRESCRIPTION DRUG LABEL	4