Desoximetasone

Product NDC
63187-646
11-digit product format
631870646
Labeler code
63187
Product ID
63187-646_4c6cb7aa-0384-4ff9-b9c8-60d24754d7af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA076510
Marketing category
ANDA
Marketing start
2006-10-24
Substance
DESOXIMETASONE
Active strength
2.5 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
A076510-001DESOXIMETASONEDESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076510-001AB

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 06:07:402026-07A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-013f01610625f2…
2019-09-15 20:21 UTC2019-09A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076510-001DESOXIMETASONE0.25%CREAM / TOPICALAB2003-07-01e64feba35796…

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 06:07:402026-07A076510-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076510-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076510-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076510-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076510-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076510-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076510-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076510-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076510-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076510-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076510-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076510-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076510-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076510-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076510-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076510-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076510-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076510-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076510-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076510-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076510-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076510-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076510-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076510-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076510-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076510-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076510-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076510-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076510-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076510-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076510-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076510-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076510-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076510-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076510-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076510-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076510-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076510-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076510-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076510-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE2.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4E07GXB7AUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197574Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f90b0cd-9443-4940-8781-1a05e42ccbb8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83e6065d-d4c9-f323-882e-7de38bb4d6acProduct name920200701
7b3bb32e-bbfd-11d9-a253-bc78b5f7d7beProduct name320190204
08e04f33-a0f6-279a-7d07-56df7c40d693Product name320180605
d67f22fb-500c-d680-0b1d-d0de623f55e7Product name720171113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-646-15Desoximetasone15 g in 1 TUBECREAM154
63187-646-15Desoximetasone1 in 1 CARTONCREAM14
63187-646-60Desoximetasone60 g in 1 TUBECREAM604
63187-646-60Desoximetasone1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-646DESOXIMETASONE CREAM [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20200619_4f90b0cd-9443-4940-8781-1a05e42ccbb8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesoximetasoneDESOXIMETASONEA-S Medication Solutions54743c9d-badd-47ce-bf86-6a8c398f7f072026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076510
application number: ANDA076510
DesoximetasoneDESOXIMETASONEBryant Ranch Prepack302fc53a-2779-4168-b76c-9ae0cf0b33312025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076510
application number: ANDA076510
DesoximetasoneDESOXIMETASONEPadagis Israel Pharmaceuticals Ltd4ad6c159-4daa-4a33-8db6-351b5263323d2025-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076510
application number: ANDA076510
DesoximetasoneDESOXIMETASONEProficient Rx LP4f90b0cd-9443-4940-8781-1a05e42ccbb82020-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076510
application number: ANDA076510
ndc (product): 63187-646

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197574desoximetasone 0.25 % Topical CreamPSN4f90b0cd-9443-4940-8781-1a05e42ccbb84
197574desoximetasone 2.5 MG/ML Topical CreamSCD4f90b0cd-9443-4940-8781-1a05e42ccbb84
197574desoximetasone 0.25 % Topical CreamSY4f90b0cd-9443-4940-8781-1a05e42ccbb84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-646-15631870646151 TUBE in 1 CARTON (63187-646-15) / 15 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent
63187-646-60631870646601 TUBE in 1 CARTON (63187-646-60) / 60 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent