Desonide

Product NDC: 80425-0371
11-digit product format: 804250371
Labeler code: 80425
Product ID: 80425-0371_2a999573-102d-813a-e063-6294a90a49b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA210198
Marketing category: ANDA
Marketing start: 2023-12-07
Substance: DESONIDE
Active strength: .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 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
A210198-001	DESONIDE	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210198-001	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.

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	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210198-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210198-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210198-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210198-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210198-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210198-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210198-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210198-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210198-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210198-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210198-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210198-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210198-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210198-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210198-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210198-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210198-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210198-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210198-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210198-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210198-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210198-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210198-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210198-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210198-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210198-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210198-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210198-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210198-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210198-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210198-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210198-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210198-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210198-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210198-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210198-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210198-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210198-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210198-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESONIDE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J280872D1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349351	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
0beda157-efd4-5245-e063-6394a90a6911	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0371-1	Desonide	1 in 1 CARTON	CREAM	1		2
80425-0371-1	Desonide	60 g in 1 TUBE	CREAM	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0371-1	GM - Gram	80425-0371	c70d6a04-c571-4179-954e-dd0e47274e94	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0371	DESONIDE CREAM [ADVANCED RX OF TENNESSEE, LLC]	2	Current NDC, 2 package rows	20250101_0beda157-efd4-5245-e063-6394a90a6911.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desonide	DESONIDE	Bryant Ranch Prepack	0892a9fd-74e6-4a5e-8bc8-9d4146cadb61	2026-04-01	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198
Desonide	DESONIDE	Bryant Ranch Prepack	c70aabe7-c044-40cd-b17d-35c665160c9c	2026-04-01	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198
Desonide	DESONIDE	Bryant Ranch Prepack	217e953b-4296-4c5a-ae07-675c96c35249	2026-03-20	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198
Desonide	DESONIDE	Viona Pharmaceuticals Inc	fdeb2a20-a612-4ae5-9178-222295271274	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198
Desonide	DESONIDE	Zydus Lifesciences Limited	e381c179-426d-4e4d-9f67-00ac632ac03e	2026-01-12		Exact identifier application applno (ANDA): 210198 application number: ANDA210198
Desonide	DESONIDE	Advanced Rx of Tennessee, LLC	0beda157-efd4-5245-e063-6394a90a6911	2024-12-31	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198 ndc (product): 80425-0371

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	0beda157-efd4-5245-e063-6394a90a6911	2
349351	desonide 0.5 MG/ML Topical Cream	SCD	0beda157-efd4-5245-e063-6394a90a6911	2
349351	desonide 0.05 % Topical Cream	SY	0beda157-efd4-5245-e063-6394a90a6911	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0371-1	80425037101	1 TUBE in 1 CARTON (80425-0371-1) / 60 g in 1 TUBE	1 tube	2023-12-07	No	No	Current