Application 087644

Type: ANDA
Sponsor: DOW PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUTRACORT	HYDROCORTISONE	LOTION;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
A087644-001	NUTRACORT	HYDROCORTISONE	2.5%	LOTION / TOPICAL			1982-08-24

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	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087644-001	NUTRACORT	2.5%	LOTION / TOPICAL	1982-08-24	`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 9 of 19 · 377 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Viaderma Calm Anti-Itch	HYDROCORTISONE	ViaDerma Distribution, Inc.	7afa2ccd-bfc6-48fc-9a14-a0c6d645844e	2025-10-01	Warnings	Name fallback generic name: HYDROCORTISONE
LEADER HYDROCORTISONE WITH ALOE	HYDROCORTISONE	LEADER	39916470-15bf-4bd0-96e2-b909d68cf9c4	2025-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Chain Drug Marketing Association Inc.	3d48a3c6-b7d6-6794-e063-6294a90afff9	2025-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
Xpect Hydrocortisone	HYDROCORTISONE	Cintas Corporation	45ef9be4-54c4-4d85-966b-27708313ded4	2025-09-26	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Walgreens Company	0b4053a8-6c1c-621d-e063-6394a90a4f56	2025-09-25	Warnings	Name fallback generic name: HYDROCORTISONE
Unishield 1%	HYDROCORTISONE	Unishield	4871a67f-fbb8-4a6b-ace4-d34349028908	2025-09-24	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0d85f349-2dc7-44a5-b5bd-83ac78d44d1d	2025-09-24	Adverse reactions	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Major Pharmaceuticals	91885fc8-876f-4a4d-8ae5-eb246a335808	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	282ed5ef-8c2a-4092-9d99-1a7eee7a39e3	2025-09-09	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	e90df2e5-2ef4-47dd-bd74-be9cea6d9d85	2025-09-08	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	2025-09-08	Warnings	Name fallback generic name: HYDROCORTISONE
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE	HYDROCORTISONE	Click Industries LLC	328c389c-7e05-4892-a9b3-b6a753f4935a	2025-08-25	Warnings	Name fallback generic name: HYDROCORTISONE
SurviveX Hydrocortisone Cream	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	3bd1da8d-5142-798c-e063-6294a90a7be6	2025-08-07	Warnings	Name fallback generic name: HYDROCORTISONE
Alumier MD Intensive Recovery	HYDROCORTISONE	Alumier Labs	d9b79ea1-6558-543c-e053-2995a90ae53e	2025-08-06	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	HF Acquisition Co LLC, DBA HealthFirst	3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6	2025-08-05	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Cooling	HYDROCORTISONE	Chattem, Inc.	14d9fce2-9f54-4204-83cb-161de8a303f0	2025-08-01	Warnings	Name fallback generic name: HYDROCORTISONE
Rite Aid anti-itch	HYDROCORTISONE	Rite Aid Corporation	2a232dd1-9071-4c55-a7f7-19d8404b99a6	2025-07-28	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	RITE AID CORPORATION	05598255-3e7a-46a5-ae7e-dcfcb616d59d	2025-07-28	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	TARGET Corporation	682b737f-e453-4079-bf31-47a9485c7897	2025-07-25	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	9bac1869-8072-49bd-8568-a87a184d2200	2025-07-21	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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