Desoximetasone

Product NDC
51672-1352
11-digit product format
516721352
Labeler code
51672
Product ID
51672-1352_390c5ade-f985-c789-e063-6294a90a6d9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA018594
Marketing category
NDA
Marketing start
1985-01-17
Substance
DESOXIMETASONE
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
N018594-001TOPICORTDESOXIMETASONE0.05%OINTMENT / TOPICALABRLD, RS1985-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018594-001AB

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 06:07:402026-07N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-173f01610625f2…
2019-09-15 20:21 UTC2019-09N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018594-001TOPICORT0.05%OINTMENT / TOPICALABRLD, RS1985-01-17e64feba35796…

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 06:07:402026-07N018594-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018594-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018594-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018594-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018594-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018594-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018594-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018594-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018594-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018594-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018594-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018594-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018594-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018594-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018594-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018594-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018594-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018594-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018594-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018594-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018594-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018594-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018594-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018594-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018594-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018594-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018594-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018594-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018594-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018594-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018594-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018594-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018594-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018594-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018594-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018594-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018594-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018594-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018594-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018594-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE.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
141850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
96898d55-aa50-4281-8c23-ec4738ede394Available 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
51672-1352-1Desoximetasone15 g in 1 TUBEOINTMENT154
51672-1352-1Desoximetasone1 in 1 CARTONOINTMENT14
51672-1352-2Desoximetasone30 g in 1 TUBEOINTMENT304
51672-1352-2Desoximetasone1 in 1 CARTONOINTMENT14
51672-1352-3Desoximetasone1 in 1 CARTONOINTMENT14
51672-1352-3Desoximetasone60 g in 1 TUBEOINTMENT604
51672-1352-7Desoximetasone1 in 1 CARTONOINTMENT14
51672-1352-7Desoximetasone100 g in 1 TUBEOINTMENT1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1352-3GM - Gram51672-13526a939487-f3bf-4d54-a4d8-bbe525a9578312012-07-24
51672-1352-7GM - Gram51672-13527d4dce65-1b5e-4c1c-8a1c-097257d3fe5612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesoximetasoneACTIVE INGREDIENT4E07GXB7AUDESOXIMETASONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
DesoximetasoneACTIVE MOIETY4E07GXB7AUDESOXIMETASONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPDESOXIMETASONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UDESOXIMETASONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1352DESOXIMETASONE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 8 package rows20170509_96898d55-aa50-4281-8c23-ec4738ede394.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.96dfac6f-540f-4b7d-bcee-7e62088ebc932026-03-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 018594
application number: NDA018594
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.96898d55-aa50-4281-8c23-ec4738ede3942025-07-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 018594
application number: NDA018594
ndc (product): 51672-1352

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141850desoximetasone 0.05 % Topical OintmentPSN96898d55-aa50-4281-8c23-ec4738ede3944
141850desoximetasone 0.0005 MG/MG Topical OintmentSCD96898d55-aa50-4281-8c23-ec4738ede3944
141850desoximetasone 0.05 % Topical OintmentSY96898d55-aa50-4281-8c23-ec4738ede3944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1352-1516721352011 TUBE in 1 CARTON (51672-1352-1) / 15 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent
51672-1352-2516721352021 TUBE in 1 CARTON (51672-1352-2) / 30 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent
51672-1352-3516721352031 TUBE in 1 CARTON (51672-1352-3) / 60 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent
51672-1352-7516721352071 TUBE in 1 CARTON (51672-1352-7) / 100 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent