Desonide

Product NDC
72603-164
11-digit product format
726030164
Labeler code
72603
Product ID
72603-164_adfa045e-ce4b-4195-962f-1c3165667119
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
Application
ANDA074254
Marketing category
ANDA
Marketing start
2023-09-07
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
A074254-001DESONIDEDESONIDE0.05%OINTMENT / TOPICALAB1994-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074254-001AB

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 06:07:402026-07A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-033f01610625f2…
2019-09-15 20:21 UTC2019-09A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074254-001DESONIDE0.05%OINTMENT / TOPICALAB1994-08-03e64feba35796…

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 06:07:402026-07A074254-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074254-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074254-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074254-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074254-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074254-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074254-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074254-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074254-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074254-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074254-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074254-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074254-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074254-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074254-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074254-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074254-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074254-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074254-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074254-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074254-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074254-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074254-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074254-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074254-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074254-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074254-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074254-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074254-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074254-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074254-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074254-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074254-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074254-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074254-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074254-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074254-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074254-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074254-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074254-001AB1e64feba35796…

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
204135Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bec5bd7f-2837-4767-8aa2-582cf58c6d2fAvailable 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
72603-164-01Desonide1 in 1 CARTONOINTMENT11
72603-164-01Desonide15 g in 1 TUBEOINTMENT151
72603-164-02Desonide60 g in 1 TUBEOINTMENT601
72603-164-02Desonide1 in 1 CARTONOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-164-01GM - Gram72603-164cd4039fe-a1cb-4e66-a782-cf107266da9212024-01-04
72603-164-02GM - Gram72603-164895f0b64-bfd3-4e0c-ac79-a0e999e4967a12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-164DESONIDE OINTMENT [NORTHSTAR RX LLC]1Current NDC, 4 package rows20230919_bec5bd7f-2837-4767-8aa2-582cf58c6d2f.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): 074254
application number: ANDA074254
DesonideDESONIDENORTHSTAR RX LLCbec5bd7f-2837-4767-8aa2-582cf58c6d2f2023-09-14Adverse reactionsExact identifier
application applno (ANDA): 074254
application number: ANDA074254
ndc (product): 72603-164

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204135desonide 0.05 % Topical OintmentPSNbec5bd7f-2837-4767-8aa2-582cf58c6d2f1
204135desonide 0.0005 MG/MG Topical OintmentSCDbec5bd7f-2837-4767-8aa2-582cf58c6d2f1
204135desonide 0.05 % Topical OintmentSYbec5bd7f-2837-4767-8aa2-582cf58c6d2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-164-01726030164011 TUBE in 1 CARTON (72603-164-01) / 15 g in 1 TUBE1 tube2023-09-07NoNoCurrent
72603-164-02726030164021 TUBE in 1 CARTON (72603-164-02) / 60 g in 1 TUBE1 tube2023-09-07NoNoCurrent