DesOwen

Product NDC: 0299-5765
11-digit product format: 002995765
Labeler code: 0299
Product ID: 0299-5765_5d3f519a-8957-4b8e-8525-88799e299f2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desonide
Dosage form: LOTION
Route: TOPICAL
Labeler: Galderma Laboratories, L.P.
Application: ANDA072354
Marketing category: ANDA
Marketing start: 1988-07-15
Marketing end: 0000-00-00
Substance: DESONIDE
Active strength: 1 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0299-5765		D	Discontinued by firm	2026-08-10
excluded package	package	0299-5765	0299-5765-02	D	Discontinued by firm	2026-08-10
excluded package	package	0299-5765	0299-5765-04	D	Discontinued by firm	2026-08-10

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0299-5765		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0299-5765	0299-5765-02	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0299-5765	0299-5765-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A072354-001	DESOWEN	DESONIDE	0.05%	LOTION / TOPICAL			1992-01-24

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL			1992-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL			1992-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A072354-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072354-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072354-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072354-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072354-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072354-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072354-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072354-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072354-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072354-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072354-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072354-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072354-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072354-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072354-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072354-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072354-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072354-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072354-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072354-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072354-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072354-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072354-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072354-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072354-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072354-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072354-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072354-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072354-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072354-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072354-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072354-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072354-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072354-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072354-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072354-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072354-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072354-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0299-5765-02	ML - Milliliter	0299-5765	62ac5a5a-e552-4378-8074-5634ab176948	1	2012-07-24
0299-5765-04	ML - Milliliter	0299-5765	4e3752c1-d82b-4153-b616-e9437860d905	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Desonide	ACTIVE INGREDIENT	J280872D1O	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Desonide	ACTIVE MOIETY	J280872D1O	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Isopropyl palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Light Mineral Oil	INACTIVE INGREDIENT	N6K5787QVP	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6
Water	INACTIVE INGREDIENT	059QF0KO0R	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0299-5765	DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]	7	Legacy NDC	20190206_a7e5f030-b849-4805-94e6-f45631eaa37f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desonide	DESONIDE	Bryant Ranch Prepack	84ceca9d-94af-46a2-be96-601892f2c535	2025-09-08	Adverse reactions	Exact identifier application applno (ANDA): 072354 application number: ANDA072354
Desonide	DESONIDE	Actavis Pharma, Inc.	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	2025-09-08	Adverse reactions	Exact identifier application applno (ANDA): 072354 application number: ANDA072354

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J280872D1O	DESONIDE	638-94-8	DESONIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0299-5765-02	00299576502	59 g in 1 BOTTLE (0299-5765-02)	59 g	1988-07-15	0000-00-00	No	No	Current
0299-5765-04	00299576504	1 BOTTLE in 1 CARTON (0299-5765-04) > 118 g in 1 BOTTLE	1 bottle	1988-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DesOwen	Galderma Laboratories, L.P. \| G Production Inc.	2025-08-25	HUMAN PRESCRIPTION DRUG LABEL	8