Desonide

Product NDC
16714-729
11-digit product format
167140729
Labeler code
16714
Product ID
16714-729_2ba564bf-266b-44d7-9d5f-40e20336b318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
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 · 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
0665dd04-1d0b-45bf-90e4-c6e0bd90956dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
16714-729-01Desonide15 g in 1 TUBECREAM154
16714-729-01Desonide1 in 1 CARTONCREAM14
16714-729-02Desonide1 in 1 CARTONCREAM14
16714-729-02Desonide60 g in 1 TUBECREAM604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-729-01GM - Gram16714-7297774e391-f87d-41a0-803b-906e2f9fe00e12017-11-06
16714-729-02GM - Gram16714-729a582d551-66e6-4296-8d54-da7a68e5abb512017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-729DESONIDE CREAM [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 4 package rows20230721_0665dd04-1d0b-45bf-90e4-c6e0bd90956d.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
DesonideDESONIDENORTHSTAR RX LLC0665dd04-1d0b-45bf-90e4-c6e0bd90956d2023-07-19Adverse reactionsExact identifier
application applno (ANDA): 073548
application number: ANDA073548
ndc (product): 16714-729

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN0665dd04-1d0b-45bf-90e4-c6e0bd90956d4
349351desonide 0.5 MG/ML Topical CreamSCD0665dd04-1d0b-45bf-90e4-c6e0bd90956d4
349351desonide 0.05 % Topical CreamSY0665dd04-1d0b-45bf-90e4-c6e0bd90956d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-729-01167140729011 TUBE in 1 CARTON (16714-729-01) / 15 g in 1 TUBE1 tube2017-06-010000-00-00NoNoCurrent
16714-729-02167140729021 TUBE in 1 CARTON (16714-729-02) / 60 g in 1 TUBE1 tube2017-06-010000-00-00NoNoCurrent