Topicort

Product NDC
51672-5205
Requested package NDC
51672-5205-3
11-digit product format
516725205
Labeler code
51672
Product ID
51672-5205_49cfa6c5-ce19-435b-aede-8597d8152eb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
CREAM
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA073210
Marketing category
ANDA
Marketing start
1990-11-30
Marketing end
0000-00-00
Substance
DESOXIMETASONE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51672-520551672-5205-3DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-520551672-5205-3DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51672-520551672-5205-3DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A073210-001TOPICORTDESOXIMETASONE0.05%CREAM / TOPICALABRS1990-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073210-001AB

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 06:07:402026-07A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073210-001TOPICORT0.05%CREAM / TOPICALABRS1990-11-30e64feba35796…

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 06:07:402026-07A073210-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073210-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073210-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073210-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073210-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073210-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073210-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073210-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073210-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073210-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073210-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073210-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073210-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073210-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073210-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073210-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073210-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073210-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073210-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073210-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073210-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073210-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073210-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073210-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073210-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073210-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073210-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073210-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073210-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073210-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073210-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073210-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073210-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073210-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073210-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A073210-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A073210-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073210-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073210-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073210-001AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5205-1GM - Gram51672-52057542cedb-0302-45b1-bfc7-26137ed5fcdd12012-07-24
51672-5205-3GM - Gram51672-5205f0b83cc6-83dd-42ef-a42b-9468e6402e3612012-07-24
51672-5205-7GM - Gram51672-5205bdeecc1e-c44d-48a7-b34b-addb46d79ab312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesoximetasoneACTIVE INGREDIENT4E07GXB7AUTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
DesoximetasoneACTIVE MOIETY4E07GXB7AUTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27ETOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1STOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0TOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
edetate disodiumINACTIVE INGREDIENT7FLD91C86KTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HETOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
trolamineINACTIVE INGREDIENT9O3K93S3TKTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8
waterINACTIVE INGREDIENT059QF0KO0RTOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5205TOPICORT (DESOXIMETASONE) CREAM TOPICORT (DESOXIMETASONE) GEL [TARO PHARMACEUTICALS U.S.A., INC.]11Legacy NDC20241222_1a1be0fb-c238-4990-bd48-03096bbf6052.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
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.37eb1205-1743-4480-8631-b0bbcaeb83592025-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073210
application number: ANDA073210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5205-3516725205031 TUBE in 1 CARTON (51672-5205-3) > 60 g in 1 TUBE1 tube1990-11-300000-00-00NoNoCurrent