Application 040310

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	OINTMENT;TOPICAL	2.5%	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
A040310-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL			2000-12-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040310-001	HYDROCORTISONE	2.5%	OINTMENT / TOPICAL	2000-12-29	`f41ea6bd6efb…`

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 14 of 20 · 389 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	J&A Digital Inc.	ff95a536-35b3-4006-b43c-cce359e86aa9	2024-12-10	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Post Treatment Balm	HYDROCORTISONE	Allure Labs Inc.	faa803e6-453c-4d86-85dd-5a5dcdd72d02	2024-12-05	Warnings	Name fallback generic name: HYDROCORTISONE
CliniCalm	HYDROCORTISONE	CP Skin Health Group, Inc.	febcf7e8-668c-a5c9-e053-6394a90aec39	2024-12-03	Warnings	Name fallback generic name: HYDROCORTISONE
First Aid Only Hydrocortisone 1% Anti-Itch	HYDROCORTISONE	Acme United Corporation	e5597b11-b08e-99e1-e053-2a95a90a15a5	2024-11-19	Warnings	Name fallback generic name: HYDROCORTISONE
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	c6b9c4e1-bab8-490d-8c00-c43377ad0857	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Walgreen Company	1a9b8b4c-3e15-49e6-af91-76ed0dc0829e	2024-11-15	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	d1ac686e-62f2-4177-8abc-8c7ca578de1a	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	a0d0e82b-03ff-4d43-9be0-0e414ee49970	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
DG health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	40710bae-32bb-47fd-b3dd-31d2c98ee70f	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
careone anti itch	HYDROCORTISONE	American Sales Company	5f7b1435-ebee-4093-847a-79e8d6641404	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	ALLIED TRADE LINK LLC	26bc238d-3bda-0c29-e063-6394a90a35fb	2024-11-12	Warnings	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Acme United Corporation	fabcaa3b-d189-bd29-e053-6294a90ae86b	2024-11-12	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Kroger Company	fc1677f2-4078-4ebd-9c3b-86a29a35b489	2024-11-12	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone with Aloe	HYDROCORTISONE	A-S Medication Solutions	3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3	2024-11-04	Warnings	Name fallback generic name: HYDROCORTISONE
cortisone	HYDROCORTISONE	CVS Pharmacy	c766deac-d993-4e48-a5c3-4cfde7338dff	2024-10-31	Warnings	Name fallback generic name: HYDROCORTISONE
dg health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	27dc9e09-fc4f-4b66-a303-177725f3a513	2024-10-31	Warnings	Name fallback generic name: HYDROCORTISONE
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	f5419859-3f9f-43ff-9a3f-6aa81af044f0	2024-10-31	Warnings	Name fallback generic name: HYDROCORTISONE
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	beefab66-b056-4bf1-b047-0780704ab87e	2024-10-29	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	H E B	15eb4676-5f6e-4c28-b5b9-4e45412dc37a	2024-10-29	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17768	ORIG	2004-06-07
42615	ORIG	2003-07-31
7619	ORIG	2000-12-29