Home NDC 0299-5770 DesOwen
Product NDC 0299-5770
11-digit product format 002995770
Labeler code 0299
Product ID 0299-5770_5d3f519a-8957-4b8e-8525-88799e299f2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desonide
Dosage form CREAM
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA019048
Marketing category NDA
Marketing start 1984-12-14
Marketing end 0000-00-00
Substance DESONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0299-5770 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0299-5770 0299-5770-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0299-5770 0299-5770-15 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 N019048-001 DESOWEN DESONIDE 0.05% CREAM / TOPICAL AB 1984-12-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019048-001 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 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019048-001 DESOWEN 0.05% CREAM / TOPICAL AB 1984-12-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Desonide ACTIVE INGREDIENT J280872D1O DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Desonide ACTIVE MOIETY J280872D1O DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Cetyl alcohol INACTIVE INGREDIENT 936JST6JCN DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Edetate sodium INACTIVE INGREDIENT MP1J8420LU DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Isopropyl palmitate INACTIVE INGREDIENT 8CRQ2TH63M DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Potassium sorbate INACTIVE INGREDIENT 1VPU26JZZ4 DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Sodium hydroxide INACTIVE INGREDIENT 55X04QC32I DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Sorbic Acid INACTIVE INGREDIENT X045WJ989B DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6 Water INACTIVE INGREDIENT 059QF0KO0R DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-5770 DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.] 7 Legacy NDC 20190206_a7e5f030-b849-4805-94e6-f45631eaa37f.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0299-5770-15 00299577015 1 TUBE in 1 CARTON (0299-5770-15) > 15 g in 1 TUBE 1 tube 1984-12-14 0000-00-00 No No Current 0299-5770-60 00299577060 1 TUBE in 1 CARTON (0299-5770-60) > 60 g in 1 TUBE 1 tube 1984-12-14 0000-00-00 No No Current