Home Applications 086257 Application 086257
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE OINTMENT;TOPICAL 1% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A086257-001 HYDROCORTISONE HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982
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 · 43 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 2026-09-14 22:38:34 2026-08 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 7 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone 1% Anti-Itch Cream HYDROCORTISONE DLC Laboratories, Inc. 16eeec2c-065d-4da0-e063-6294a90a3873 2026-01-07 Warnings Name fallback generic name: HYDROCORTISONE Maximum Strength Hydrocortisone HYDROCORTISONE DLC Laboratories, Inc caf50f12-f35c-4e9e-8ef7-3b0c84e225ee 2026-01-07 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Padagis Israel Pharmaceuticals Ltd 7ba59aa6-b828-4048-bf86-90c90d9894a0 2026-01-06 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Procto-Med HC HYDROCORTISONE Leading Pharma, LLC 0682580e-aff8-4b67-99ba-a29ab7b433db 2026-01-06 Adverse reactions Name fallback generic name: HYDROCORTISONE HYDROCORTISONE ANTI-ITCH CREAM Water-Jel Technologies 3d34ae31-265a-46bc-a52d-546ea5bb24b6 2025-12-31 Warnings Name fallback brand name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE AKRON PHARMA INC fa956b6a-1712-4f7a-9490-11866dcd17c8 2025-12-29 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Nizoral Scalp Itch Relief HYDROCORTISONE Kramer Laboratories dba59238-6beb-447e-8c4c-e4bc00fd2c20 2025-12-23 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE ANI Pharmaceuticals, Inc. b2918ac7-14b5-4372-9055-8caf6f4bcf37 2025-12-22 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Caring Mills Hydrocortisone HYDROCORTISONE Veridian Healthcare b0b1889b-3099-4943-a4cb-d9a898a06860 2025-12-22 Warnings Name fallback generic name: HYDROCORTISONE Kroger Anti Itch HYDROCORTISONE The Kroger Co 46547277-f11a-b9e7-e063-6294a90a2ccd 2025-12-19 Warnings Name fallback generic name: HYDROCORTISONE Aquaphor Itch Relief HYDROCORTISONE Beiersdorf Inc b1d0333f-ba60-35d8-e053-2995a90af932 2025-12-16 Warnings Name fallback generic name: HYDROCORTISONE equate hydrocortisone HYDROCORTISONE Wal-Mart Stores Inc 70f4636d-4137-498b-ab81-0330de883e53 2025-12-15 Warnings Name fallback generic name: HYDROCORTISONE TrueLipids 1% Hydrocortisone Barrier Cream HYDROCORTISONE Claridei Laboratories 037395dc-5b96-052e-e063-6394a90a26e4 2025-12-15 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone Rectal Suspension (Retention) HYDROCORTISONE Chartwell RX LLC 3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8 2025-12-10 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Chartwell RX, LLC. 4b6edbc4-7afb-4fb5-a16e-66ce70916f09 2025-12-10 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Chartwell RX, LLC 5b707a9f-32b6-42f3-beb6-111df98dfde5 2025-12-10 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Thompson Hydrocortisone 1% HYDROCORTISONE Thompson f8740314-7e1f-815e-e053-6294a90a6eae 2025-12-05 Warnings Name fallback generic name: HYDROCORTISONE ElixirCortiRelief HYDROCORTISONE ELIXIR HEALTHCARE USA, LLC. a6ca66f3-9759-4c98-a758-45700bc08352 2025-12-02 Warnings Name fallback generic name: HYDROCORTISONE PEDIADERMICS ECZEMA 2 HYDROCORTISONE RENU LABORATORIES, LLC da840bf6-ed65-bafc-e053-2a95a90a92d5 2025-12-02 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc 7d4e21d1-2914-4690-9084-a52abeab0958 2025-12-02 Warnings Name fallback generic name: HYDROCORTISONE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.