DESONIDE

Product NDC: 52187-556
Requested package NDC: 52187-556-60
11-digit product format: 521870556
Labeler code: 52187
Product ID: 52187-556_df7434aa-d4bf-63a1-e053-2a95a90a2751
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DESONIDE
Dosage form: GEL
Route: TOPICAL
Labeler: KMM Pharmaceuticals, LLC
Application: ANDA202470
Marketing category: ANDA
Marketing start: 2022-02-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52187-556	52187-556-60	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202470-001	DESONIDE	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11

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.

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
2026-08-18 06:07:40	2026-07	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202470-001	DESONIDE	0.05%	GEL / TOPICAL	AB		2020-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202470-001	DESONIDE	0.05%	GEL / TOPICAL	AB		2020-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202470-001	DESONIDE	0.05%	GEL / TOPICAL	AB		2020-05-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202470-001	DESONIDE	0.05%	GEL / TOPICAL		RS	2020-05-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A202470-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202470-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202470-001	AB	1	`c0c555d07b60…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52187-556-60	GM - Gram	52187-556	6e305752-4319-4978-af5e-75740cc2d3ba	1	2022-04-06

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
DESONIDE	DESONIDE	Cintex Services, LLC	a6192416-09b4-47fa-e053-2a95a90add96	2020-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202470 application number: ANDA202470

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
52187-556-60	52187055660	1 TUBE in 1 CARTON (52187-556-60) > 60 g in 1 TUBE	1 tube	2022-02-28	0000-00-00	No	No	Current