Home Applications 009585 Application 009585
Type NDA
Sponsor BAYER PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CORT-DOME HYDROCORTISONE CREAM;TOPICAL 1% No No 003 CORT-DOME HYDROCORTISONE CREAM;TOPICAL 0.5% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N009585-001 CORT-DOME HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 N009585-003 CORT-DOME HYDROCORTISONE 0.5% CREAM / 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 3 · 82 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 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N009585-001 CORT-DOME 1% CREAM / TOPICAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N009585-003 CORT-DOME 0.5% CREAM / TOPICAL Approved before 1982 782e0a99824c…
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 2 of 19 · 368 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Scalpicin Anti-Itch Maximum Strength HYDROCORTISONE Reckitt Benckiser LLC 7b1a29fa-b266-43e6-a87b-aa3c96ab4041 2026-05-13 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals Inc. 02ab1006-c7c8-42c9-bda8-62c9d7142521 2026-05-11 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals, Inc. 058bb2ff-ff51-4a3b-ba47-cb02272d0631 2026-05-11 Adverse reactions Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals Inc. 12cd35e3-e707-4551-b778-bf615c1a8d32 2026-05-11 Warnings Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Preferred Pharmaceuticals Inc. 0bbb8a63-ae1d-41d7-b201-d1b171b31f46 2026-05-11 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals, Inc. 026728d4-846b-4bd4-9183-ae6c4a714138 2026-05-11 Adverse reactions Name fallback generic name: HYDROCORTISONE Harris Teeter Hydrocortisone HYDROCORTISONE HARRIS TEETER LLC 4e8199f8-96ec-5342-e063-6294a90afb2d 2026-05-07 Warnings Name fallback generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 5114cdba-96a1-c399-e063-6294a90aac12 2026-05-06 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Padagis Israel Pharmaceuticals Ltd 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 2026-04-29 Warnings Name fallback generic name: HYDROCORTISONE anti itch HYDROCORTISONE HyVee Inc e1db3641-2e83-4fec-8394-98d0d876ce0d 2026-04-29 Warnings Name fallback generic name: HYDROCORTISONE FixMySkin Healing Balm Vanilla Flavor HYDROCORTISONE Lovely Skin, Inc. 52f7a561-a0b5-4562-a588-d74fd874b83a 2026-04-28 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sportpharm LLC ef9cf62a-5805-48bc-915e-c0e91a10837e 2026-04-24 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sportpharm LLC 78f43570-b6fd-42eb-bb9e-580abf79bf0d 2026-04-24 Adverse reactions Name fallback generic name: HYDROCORTISONE FixMySkin Healing Balm Unflavored HYDROCORTISONE Lovely Skin, Inc. 9ff8db07-ad6d-4865-a534-94bd8312957e 2026-04-23 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack c3916e9f-f783-45a2-b38b-959b12c26252 2026-04-22 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone 1% HYDROCORTISONE Preferred Pharmaceuticals Inc. e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4 2026-04-22 Warnings Name fallback generic name: HYDROCORTISONE Alkindi Sprinkle HYDROCORTISONE Eton Pharmaceuticals, Inc. 26c13a5f-7119-4c6a-bf10-fda4e07d7682 2026-04-21 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Anti-Itch Regular Strength HYDROCORTISONE CVS Pharmacy 9fe7768b-9023-c9ee-e053-2a95a90a55b3 2026-04-17 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 2352bb58-a624-4c5e-8966-f68817c30470 2026-04-03 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE REMEDYREPACK INC. f0e66726-946b-4f63-b457-2851dc69e6b4 2026-04-03 Adverse reactions Name fallback generic name: HYDROCORTISONE