Home NDC 0472-0803 Desonide
Product NDC 0472-0803
11-digit product format 004720803
Labeler code 0472
Product ID 0472-0803_f3953b9e-138f-4d86-8eea-0fc03c3c2747
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desonide
Dosage form LOTION
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application ANDA072354
Marketing category ANDA
Marketing start 2009-05-28
Marketing end 2028-03-31
Substance DESONIDE
Active strength .5 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
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 A072354-001 DESOWEN DESONIDE 0.05% LOTION / TOPICAL 1992-01-24
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 A072354-001 DESOWEN 0.05% LOTION / TOPICAL 1992-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL 1992-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Desonide Active Ingredients# Ingredient, Strength table Ingredient Strength DESONIDE .5 mg/mL
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 197572 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 0472-0803-02 Desonide 1 in 1 CARTON LOTION 1 5 0472-0803-02 Desonide 59 mL in 1 BOTTLE LOTION 59 5 0472-0803-04 Desonide 118 mL in 1 BOTTLE LOTION 118 5 0472-0803-04 Desonide 1 in 1 CARTON LOTION 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESONIDE ACTIVE INGREDIENT J280872D1O DESONIDE LOTION [ACTAVIS MID ATLANTIC LLC, LINCOLNTON, NC 28092] 2 DESONIDE ACTIVE MOIETY J280872D1O DESONIDE LOTION [ACTAVIS MID ATLANTIC LLC, LINCOLNTON, NC 28092] 2 DESONIDE ACTIVE INGREDIENT J280872D1O DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 DESONIDE ACTIVE MOIETY J280872D1O DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0472-0803 DESONIDE CREAM DESONIDE LOTION [ACTAVIS PHARMA, INC.] 3 Current NDC, Legacy NDC, 4 package rows 20190206_ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99.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 0472-0803-02 00472080302 1 BOTTLE in 1 CARTON (0472-0803-02) / 59 mL in 1 BOTTLE 1 bottle 2009-05-28 2027-02-28 No No Current 0472-0803-04 00472080304 1 BOTTLE in 1 CARTON (0472-0803-04) / 118 mL in 1 BOTTLE 1 bottle 2009-05-28 2028-03-31 No No Current