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 8 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone HYDROCORTISONE Trifluent Pharma LLC 20508a94-01bc-4f1d-a42b-122a31402aaf 2025-12-01 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc e2df8130-e7c8-4fde-a6d6-c71378991213 2025-12-01 Warnings Name fallback generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc d04e473d-8bbc-475c-a0b1-ca5eed67fbc7 2025-12-01 Warnings Name fallback generic name: HYDROCORTISONE Aquanil HC HYDROCORTISONE Person and Covey 6b9258e4-c7c4-765e-e053-2991aa0a9f4e 2025-11-29 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Henry Schein eb031535-d17e-9d5e-e053-2a95a90ad3e0 2025-11-25 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone ANTI-PRURITIC Cardinal Health 8b3af210-3097-8c10-e053-2a95a90a86f1 2025-11-25 Warnings Name fallback brand name: Hydrocortisone Hydrocortisone ANTI-ITCH Cardinal Health 884c8227-b4f3-7ef1-e053-2995a90a0ee3 2025-11-25 Warnings Name fallback brand name: Hydrocortisone health beyond HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af 2025-11-23 Warnings Name fallback generic name: HYDROCORTISONE Absolut Skin Corticosoothe Anti-Itch HYDROCORTISONE Absolut Skin Incorporated deb52218-9176-4aaa-a22f-b66dada6690f 2025-11-19 Warnings Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Encube Ethicals, Inc. 969cd576-82d3-4662-bbc1-3587a1f6a564 2025-11-10 Warnings Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE HEALING TREE CALMING ANTI-ITCH HYDROCORTISONE Renu Laboratories, LLC fc8bcde9-26e8-a35f-e053-6394a90a3300 2025-11-06 Warnings Name fallback generic name: HYDROCORTISONE Proctosol-HC HYDROCORTISONE Bryant Ranch Prepack 68e177fd-87aa-45f3-a380-0d092abdb77d 2025-11-05 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack b6808d2d-192c-4d70-a2e8-bf13375c0280 2025-11-05 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone Anti-Itch HYDROCORTISONE Universal Distribution Center LLC 186afb11-06b6-4bfa-e063-6294a90aefc6 2025-10-30 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE SPRAY Meijer Distribution Inc. 28daaf97-b0b3-7a54-e063-6294a90a23f1 2025-10-30 Warnings Name fallback brand name: Hydrocortisone CVS Cools Itch Fast HYDROCORTISONE CVS Pharmacy, Inc. 8a4544df-bbba-47d2-ada0-352757abc91f 2025-10-29 Warnings Name fallback generic name: HYDROCORTISONE Winco Maximum Strength Hydrocortisone HYDROCORTISONE WINCO FOODS, LLC b1812ea3-78cc-607a-e053-2a95a90a0a10 2025-10-29 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 8c03671d-28ab-4027-8f5f-d342177ce5f2 2025-10-28 Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE CONTINUOUS SPRAY Premier Brands of America, Inc. d344f68b-9b62-3029-e053-2995a90a1665 2025-10-27 Warnings Name fallback brand name: Hydrocortisone WinCo Foods Hydrocortisone Cream Intensive Healing HYDROCORTISONE WINCO FOODS, LLC ac4e0e24-9295-b83b-e053-2995a90a996f 2025-10-22 Warnings Name fallback generic name: HYDROCORTISONE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.