Desonide

Product NDC: 50436-3300
11-digit product format: 504363300
Labeler code: 50436
Product ID: 50436-3300_80c5fac9-05cb-43ef-9f41-e6e21ec600f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Unit Dose Services
Application: ANDA074027
Marketing category: ANDA
Marketing start: 2016-08-19
Marketing end: 0000-00-00
Substance: DESONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50436-3300		I	Inactivated by FDA		2026-08-17
excluded package	package	50436-3300	50436-3300-1	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 · 30 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	50436-3300-1	`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	50436-3300-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-3300-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-3300-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-3300-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-3300-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-3300-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-3300-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-3300-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-3300-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-3300-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-3300-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-3300-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-3300-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-3300-1	`1332a3947898…`	`d4bfe170f9cd…`

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
A074027-001	DESONIDE	DESONIDE	0.05%	CREAM / TOPICAL	AB		1992-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074027-001	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	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074027-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	1992-09-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074027-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074027-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
a4783074-7e0b-e965-10c3-0421e26d5ede	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-3300-1	2024-01-30	C162847	48780-1	1030e365-4b99-111a-e063-dadaa90a10e2	Desonide Cream, 0.05% For Dermatologic Use Only Not For Ophthalmic Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-3300-1	Desonide	60 g in 1 TUBE	CREAM	60		2
50436-3300-1	Desonide	1 in 1 CARTON	CREAM	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-3300-1	GM - Gram	50436-3300	7fb92dac-87b0-4be4-bf05-62829ab6499c	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3300	DESONIDE (DESONIDE) CREAM [UNIT DOSE SERVICES]	2	Legacy NDC, 2 package rows	20220803_843dc9e3-9edf-43da-aa0b-ff25dcd440e6.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	Advanced Rx of Tennessee, LLC	1d7632a7-0f27-9e5d-e063-6294a90ad21f	2024-07-17	Adverse reactions	Exact identifier application applno (ANDA): 074027 application number: ANDA074027
Desonide	DESONIDE	Cosette Pharmaceuticals, Inc.	51e39fd1-2ae7-9ed6-5f24-c4656dd97f0b	2022-11-22	Adverse reactions	Exact identifier application applno (ANDA): 074027 application number: ANDA074027

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	843dc9e3-9edf-43da-aa0b-ff25dcd440e6	2
349351	desonide 0.5 MG/ML Topical Cream	SCD	843dc9e3-9edf-43da-aa0b-ff25dcd440e6	2
349351	desonide 0.05 % Topical Cream	SY	843dc9e3-9edf-43da-aa0b-ff25dcd440e6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-3300-1	50436330001	1 TUBE in 1 CARTON (50436-3300-1) > 60 g in 1 TUBE	1 tube	2022-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desonide Cream, 0.05% For Dermatologic Use Only Not For Ophthalmic Use Rx Only	Unit Dose Services	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	2