Desonide

Product NDC: 0472-0804
11-digit product format: 004720804
Labeler code: 0472
Product ID: 0472-0804_f3953b9e-138f-4d86-8eea-0fc03c3c2747
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: NDA019048
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-08-01
Marketing end: 2026-07-31
Substance: DESONIDE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
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	0472-0804		D	Discontinued by firm	2026-08-10
excluded package	package	0472-0804	0472-0804-15	D	Discontinued by firm	2026-08-10
excluded package	package	0472-0804	0472-0804-60	D	Discontinued by firm	2026-08-10

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
N019048-001	DESOWEN	DESONIDE	0.05%	CREAM / TOPICAL	AB		1984-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019048-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019048-001	DESOWEN	0.05%	CREAM / TOPICAL	AB	1984-12-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019048-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019048-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019048-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019048-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019048-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019048-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019048-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019048-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019048-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019048-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019048-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019048-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019048-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019048-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019048-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019048-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019048-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019048-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019048-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019048-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019048-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019048-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019048-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019048-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019048-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019048-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019048-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019048-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019048-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019048-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019048-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019048-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019048-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019048-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019048-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019048-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019048-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019048-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019048-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019048-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5dd568b3-c283-39c3-9c72-0b51d8c13e5d	Product name	2	20201006
0d789796-3334-08b7-795a-b9c3762179bc	Product name	2	20200506
6da396dc-a1b2-d109-14be-877a0fdbfa18	Product name	5	20200408
4fa39b20-3e53-46d7-85e4-edc2360cfdff	Product name	1	20171115
a4783074-7e0b-e965-10c3-0421e26d5ede	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0472-0804-15	Desonide	1 in 1 CARTON	CREAM	1	5
0472-0804-15	Desonide	15 g in 1 TUBE	CREAM	15	5
0472-0804-60	Desonide	60 g in 1 TUBE	CREAM	60	5
0472-0804-60	Desonide	1 in 1 CARTON	CREAM	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0804-15	GM - Gram	0472-0804	69b86945-05ce-4521-afd1-605ba6ece014	1	2013-09-04
0472-0804-60	GM - Gram	0472-0804	c02ee2ff-70d6-43dc-9980-537fbe23015c	1	2013-09-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0804	DESONIDE CREAM DESONIDE LOTION [ACTAVIS PHARMA, INC.]	3	Current NDC, Legacy NDC, 4 package rows	20190206_ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99.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	Actavis Pharma, Inc.	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	2025-09-08	Adverse reactions	Exact identifier ndc (product): 0472-0804
Desonide	DESONIDE	Proficient Rx LP	81a8b199-524e-40e4-898a-c485cbf8bc22	2025-05-01	Adverse reactions	Exact identifier application applno (NDA): 019048 application number: NDA019048

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349351	desonide 0.05 % Topical Cream	PSN	81a8b199-524e-40e4-898a-c485cbf8bc22	5
349351	desonide 0.05 % Topical Cream	PSN	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	5
197572	desonide 0.05 % Topical Lotion	PSN	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	5
349351	desonide 0.5 MG/ML Topical Cream	SCD	81a8b199-524e-40e4-898a-c485cbf8bc22	5
349351	desonide 0.5 MG/ML Topical Cream	SCD	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	5
197572	desonide 0.5 MG/ML Topical Lotion	SCD	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	5
349351	desonide 0.05 % Topical Cream	SY	81a8b199-524e-40e4-898a-c485cbf8bc22	5
349351	desonide 0.05 % Topical Cream	SY	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	5
197572	desonide 0.05 % Topical Lotion	SY	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-0804-15	00472080415	1 TUBE in 1 CARTON (0472-0804-15) / 15 g in 1 TUBE	1 tube	2013-08-01	2026-07-31	No	No	Current
0472-0804-60	00472080460	1 TUBE in 1 CARTON (0472-0804-60) / 60 g in 1 TUBE	1 tube	2013-08-01	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DESONIDE Rx Only cream 0.05% and lotion 0.05% For Dermatologic Use Only – Not for Ophthalmic Use –	Actavis Pharma, Inc. \| G Production Inc.	2025-09-08	HUMAN PRESCRIPTION DRUG LABEL	5
Desonide	Proficient Rx LP	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	5