Desonide

Product NDC
51672-1280
11-digit product format
516721280
Labeler code
51672
Product ID
51672-1280_38f4eb47-a888-b419-e063-6394a90a6442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA073548
Marketing category
ANDA
Marketing start
1992-06-30
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
A073548-001DESONIDEDESONIDE0.05%CREAM / TOPICALAB1992-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073548-001AB

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 06:07:402026-07A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-303f01610625f2…
2019-09-15 20:21 UTC2019-09A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073548-001DESONIDE0.05%CREAM / TOPICALAB1992-06-30e64feba35796…

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 06:07:402026-07A073548-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073548-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073548-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073548-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073548-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073548-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073548-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073548-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073548-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073548-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073548-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073548-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073548-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073548-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073548-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073548-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073548-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073548-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073548-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073548-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073548-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073548-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073548-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073548-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073548-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073548-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073548-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073548-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073548-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073548-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073548-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073548-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073548-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073548-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073548-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A073548-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A073548-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073548-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073548-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073548-001AB1e64feba35796…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204135Internal RxNorm lookup
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
6cea3912-23ae-45f3-b535-6fea29c7594fAvailable 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
51672-1280-1Desonide1 in 1 CARTONCREAM19
51672-1280-1Desonide15 g in 1 TUBECREAM159
51672-1280-3Desonide1 in 1 CARTONCREAM19
51672-1280-3Desonide60 g in 1 TUBECREAM609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1280-1GM - Gram51672-12807bb4bcb0-d929-4b4c-8b65-c4581204b76e12013-02-13
51672-1280-3GM - Gram51672-12805c3d95cf-3284-4daa-92c0-9c1b90268e3e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesonideACTIVE INGREDIENTJ280872D1ODESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
DesonideACTIVE MOIETYJ280872D1ODESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
aluminum subacetateINACTIVE INGREDIENTFGL8577C9SDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
mineral oilINACTIVE INGREDIENTT5L8T28FGPDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
petrolatumINACTIVE INGREDIENT4T6H12BN9UDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
white waxINACTIVE INGREDIENT7G1J5DA97FDESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
DESONIDEACTIVE INGREDIENTJ280872D1ODESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
DESONIDEACTIVE MOIETYJ280872D1ODESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
ALUMINUM SUBACETATEINACTIVE INGREDIENTFGL8577C9SDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FDESONIDE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1280DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]8Current NDC, Legacy NDC, 4 package rows20230202_6cea3912-23ae-45f3-b535-6fea29c7594f.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
DesonideDESONIDESun Pharmaceutical Industries, Inc.6cea3912-23ae-45f3-b535-6fea29c7594f2025-07-02Adverse reactionsExact identifier
application applno (ANDA): 073548
application number: ANDA073548
ndc (product): 51672-1280
DesonideDESONIDENORTHSTAR RX LLC0665dd04-1d0b-45bf-90e4-c6e0bd90956d2023-07-19Adverse reactionsExact identifier
application applno (ANDA): 073548
application number: ANDA073548

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN6cea3912-23ae-45f3-b535-6fea29c7594f9
204135desonide 0.05 % Topical OintmentPSN6cea3912-23ae-45f3-b535-6fea29c7594f9
204135desonide 0.0005 MG/MG Topical OintmentSCD6cea3912-23ae-45f3-b535-6fea29c7594f9
349351desonide 0.5 MG/ML Topical CreamSCD6cea3912-23ae-45f3-b535-6fea29c7594f9
349351desonide 0.05 % Topical CreamSY6cea3912-23ae-45f3-b535-6fea29c7594f9
204135desonide 0.05 % Topical OintmentSY6cea3912-23ae-45f3-b535-6fea29c7594f9
349351desonide 0.05 % Topical CreamPSN4eff4778-6ae6-4727-821d-66df5683dd9b1
349351desonide 0.5 MG/ML Topical CreamSCD4eff4778-6ae6-4727-821d-66df5683dd9b1
349351desonide 0.05 % Topical CreamSY4eff4778-6ae6-4727-821d-66df5683dd9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1280-1516721280011 TUBE in 1 CARTON (51672-1280-1) / 15 g in 1 TUBE1 tube1992-06-300000-00-00NoNoCurrent
51672-1280-3516721280031 TUBE in 1 CARTON (51672-1280-3) / 60 g in 1 TUBE1 tube1992-06-300000-00-00NoNoCurrent