Desonide

Product NDC
63187-747
11-digit product format
631870747
Labeler code
63187
Product ID
63187-747_c18f0f16-11f4-4c11-983a-27a30b71827b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
NDA019048
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-08-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019048-001DESOWENDESONIDE0.05%CREAM / TOPICALAB1984-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019048-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-143f01610625f2…
2019-09-15 20:21 UTC2019-09N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019048-001DESOWEN0.05%CREAM / TOPICALAB1984-12-14e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019048-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019048-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019048-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019048-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019048-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019048-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019048-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019048-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019048-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019048-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019048-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019048-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019048-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019048-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019048-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019048-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019048-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019048-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019048-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019048-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019048-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019048-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019048-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019048-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019048-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019048-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N019048-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019048-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019048-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019048-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019048-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019048-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019048-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019048-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019048-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019048-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019048-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019048-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019048-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019048-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J280872D1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349351Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81a8b199-524e-40e4-898a-c485cbf8bc22Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-747-15Desonide1 in 1 CARTONCREAM15
63187-747-15Desonide15 g in 1 TUBECREAM155
63187-747-60Desonide1 in 1 CARTONCREAM15
63187-747-60Desonide60 g in 1 TUBECREAM605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-747-15GM - Gram63187-747d74eb538-4477-435a-a423-1fde373d899812016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-747DESONIDE CREAM [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20250529_81a8b199-524e-40e4-898a-c485cbf8bc22.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesonideDESONIDEProficient Rx LP81a8b199-524e-40e4-898a-c485cbf8bc222025-05-01Adverse reactionsExact identifier
application applno (NDA): 019048
application number: NDA019048
ndc (product): 63187-747

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN81a8b199-524e-40e4-898a-c485cbf8bc225
349351desonide 0.5 MG/ML Topical CreamSCD81a8b199-524e-40e4-898a-c485cbf8bc225
349351desonide 0.05 % Topical CreamSY81a8b199-524e-40e4-898a-c485cbf8bc225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-747-15631870747151 TUBE in 1 CARTON (63187-747-15) / 15 g in 1 TUBE1 tube2016-10-030000-00-00NoNoCurrent
63187-747-60631870747601 TUBE in 1 CARTON (63187-747-60) / 60 g in 1 TUBE1 tube2016-10-030000-00-00NoNoCurrent