Home NDC 0713-0661-60 Desonide
Product NDC 0713-0661
Requested package NDC 0713-0661-60
11-digit product format 007130661
Labeler code 0713
Product ID 0713-0661_ee0cb97f-162c-0dc0-e053-2995a90a8db3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desonide
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA074027
Marketing category ANDA
Marketing start 2016-08-19
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 1 .
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 A074027-001 DESONIDE DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074027-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0713-0661-15 Desonide 15 g in 1 TUBE CREAM 15 6 0713-0661-15 Desonide 1 in 1 CARTON CREAM 1 6 0713-0661-60 Desonide 1 in 1 CARTON CREAM 1 6 0713-0661-60 Desonide 60 g in 1 TUBE CREAM 60 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Desonide ACTIVE INGREDIENT J280872D1O DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Desonide ACTIVE MOIETY J280872D1O DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Aluminum Sulfate INACTIVE INGREDIENT 34S289N54E DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Calcium Acetate INACTIVE INGREDIENT Y882YXF34X DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Icodextrin INACTIVE INGREDIENT 2NX48Z0A9G DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Synthetic Wax (1200 Mw) INACTIVE INGREDIENT Q3Z4BCH099 DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R DESONIDE (DESONIDE) CREAM [G&W LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0661 DESONIDE CREAM [COSETTE PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20221123_51e39fd1-2ae7-9ed6-5f24-c4656dd97f0b.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 0713-0661-60 00713066160 1 TUBE in 1 CARTON (0713-0661-60) / 60 g in 1 TUBE 1 tube 2016-08-19 0000-00-00 No No Current