Desonide

Product NDC: 45802-423
11-digit product format: 458020423
Labeler code: 45802
Product ID: 45802-423_9d27c98f-5df2-45c7-a479-a4a04128e6b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: NDA017426
Marketing category: NDA
Marketing start: 2006-08-22
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
N017426-001	DESONIDE	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017426-001	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017426-001	DESONIDE	0.05%	OINTMENT / TOPICAL	AB	RLD, RS, Approved before 1982	`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	N017426-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017426-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017426-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017426-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017426-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017426-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017426-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017426-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017426-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017426-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017426-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017426-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017426-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017426-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017426-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017426-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017426-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017426-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017426-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017426-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017426-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017426-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017426-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017426-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017426-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017426-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017426-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017426-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017426-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017426-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017426-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017426-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017426-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017426-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017426-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017426-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017426-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017426-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017426-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017426-001	AB	1	`e64feba35796…`

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
204135	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
525c035d-d54b-41c0-90c5-bcd284b1abe3	Available on FDA.report

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
45802-423-35	Desonide	15 g in 1 TUBE	OINTMENT	15	9
45802-423-35	Desonide	1 in 1 CARTON	OINTMENT	1	9
45802-423-37	Desonide	60 g in 1 TUBE	OINTMENT	60	9
45802-423-37	Desonide	1 in 1 CARTON	OINTMENT	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-423-35	GM - Gram	45802-423	cc836664-59c0-40f4-9171-064b78e3dc27	1	2012-07-24
45802-423-37	GM - Gram	45802-423	a794ac53-0fc6-4bc7-bb24-79668941665a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESONIDE	ACTIVE INGREDIENT	J280872D1O	DESONIDE OINTMENT [PERRIGO NEW YORK INC]	5
DESONIDE	ACTIVE MOIETY	J280872D1O	DESONIDE OINTMENT [PERRIGO NEW YORK INC]	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DESONIDE OINTMENT [PERRIGO NEW YORK INC]	5
DESONIDE	ACTIVE INGREDIENT	J280872D1O	DESONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]	2
DESONIDE	ACTIVE MOIETY	J280872D1O	DESONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-423	DESONIDE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]	9	Current NDC, Legacy NDC, 4 package rows	20231117_525c035d-d54b-41c0-90c5-bcd284b1abe3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desonide	DESONIDE	Padagis Israel Pharmaceuticals Ltd	525c035d-d54b-41c0-90c5-bcd284b1abe3	2022-12-01	Adverse reactions	Exact identifier application applno (NDA): 017426 application number: NDA017426 ndc (product): 45802-423

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
204135	desonide 0.05 % Topical Ointment	PSN	525c035d-d54b-41c0-90c5-bcd284b1abe3	9
204135	desonide 0.0005 MG/MG Topical Ointment	SCD	525c035d-d54b-41c0-90c5-bcd284b1abe3	9
204135	desonide 0.05 % Topical Ointment	SY	525c035d-d54b-41c0-90c5-bcd284b1abe3	9
204135	desonide 0.05 % Topical Ointment	PSN	10feb882-10f0-4e5a-8481-bcaac54dfd52	2
204135	desonide 0.0005 MG/MG Topical Ointment	SCD	10feb882-10f0-4e5a-8481-bcaac54dfd52	2
204135	desonide 0.05 % Topical Ointment	SY	10feb882-10f0-4e5a-8481-bcaac54dfd52	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-423-35	45802042335	1 TUBE in 1 CARTON (45802-423-35) / 15 g in 1 TUBE	1 tube	2006-08-22	0000-00-00	No	No	Current
45802-423-37	45802042337	1 TUBE in 1 CARTON (45802-423-37) / 60 g in 1 TUBE	1 tube	2006-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desonide Ointment, 0.05%	Bryant Ranch Prepack	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	2
Desonide Ointment, 0.05%	Padagis Israel Pharmaceuticals Ltd	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	9
DESONIDE OINTMENT, 0.05%	Physicians Total Care, Inc.	2011-12-19	HUMAN PRESCRIPTION DRUG LABEL	2