Home NDC 51672-1281 Desonide
Product NDC 51672-1281
11-digit product format 516721281
Labeler code 51672
Product ID 51672-1281_38f4eb47-a888-b419-e063-6394a90a6442
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desonide
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA074254
Marketing category ANDA
Marketing start 1994-08-03
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074254-001 DESONIDE DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074254-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074254-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 1994-08-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Desonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESONIDE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J280872D1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204135 Internal RxNorm lookup 349351 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1281-1 Desonide 15 g in 1 TUBE OINTMENT 15 9 51672-1281-1 Desonide 1 in 1 CARTON OINTMENT 1 9 51672-1281-3 Desonide 1 in 1 CARTON OINTMENT 1 9 51672-1281-3 Desonide 60 g in 1 TUBE OINTMENT 60 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Desonide ACTIVE INGREDIENT J280872D1O DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 Desonide ACTIVE MOIETY J280872D1O DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 aluminum subacetate INACTIVE INGREDIENT FGL8577C9S DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 glycerin INACTIVE INGREDIENT PDC6A3C0OX DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 methylparaben INACTIVE INGREDIENT A2I8C7HI9T DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 mineral oil INACTIVE INGREDIENT T5L8T28FGP DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 petrolatum INACTIVE INGREDIENT 4T6H12BN9U DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 sodium cetostearyl sulfate INACTIVE INGREDIENT 7ZBS06BH4B DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 white wax INACTIVE INGREDIENT 7G1J5DA97F DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1281 DESONIDE CREAM DESONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 8 Current NDC, Legacy NDC, 4 package rows 20230202_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1281-1 51672128101 1 TUBE in 1 CARTON (51672-1281-1) / 15 g in 1 TUBE 1 tube 1994-08-03 0000-00-00 No No Current 51672-1281-3 51672128103 1 TUBE in 1 CARTON (51672-1281-3) / 60 g in 1 TUBE 1 tube 1994-08-03 0000-00-00 No No Current