Home NDC 51672-4079 Desonide
Product NDC 51672-4079
11-digit product format 516724079
Labeler code 51672
Product ID 51672-4079_c5e77dd5-c1ab-4967-8000-48077b8e06f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desonide
Dosage form LOTION
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA202161
Marketing category ANDA
Marketing start 2014-10-31
Substance DESONIDE
Active strength .5 mg/mL
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 A202161-001 DESONIDE DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202161-001 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 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202161-001 DESONIDE 0.05% LOTION / TOPICAL AB 2014-10-31 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 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197572 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 51672-4079-4 Desonide 59 mL in 1 BOTTLE LOTION 59 4 51672-4079-4 Desonide 1 in 1 CARTON LOTION 1 4 51672-4079-8 Desonide 1 in 1 CARTON LOTION 1 4 51672-4079-8 Desonide 118 mL in 1 BOTTLE LOTION 118 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Desonide ACTIVE INGREDIENT J280872D1O DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Desonide ACTIVE MOIETY J280872D1O DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 diethylene glycol monoethyl ether INACTIVE INGREDIENT A1A1I8X02B DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 light mineral oil INACTIVE INGREDIENT N6K5787QVP DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4079 DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, Legacy NDC, 4 package rows 20210413_af607c32-3da9-4fbe-99e7-4934a5c8d8f0.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.
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 51672-4079-4 51672407904 1 BOTTLE in 1 CARTON (51672-4079-4) / 59 mL in 1 BOTTLE 1 bottle 2014-10-31 0000-00-00 No No Current 51672-4079-8 51672407908 1 BOTTLE in 1 CARTON (51672-4079-8) / 118 mL in 1 BOTTLE 1 bottle 2014-10-31 0000-00-00 No No Current