Application 080443

Type: ANDA
Sponsor: DOW PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	NUTRACORT	HYDROCORTISONE	LOTION;TOPICAL	0.5%	No	No
003	NUTRACORT	HYDROCORTISONE	LOTION;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080443-002	NUTRACORT	HYDROCORTISONE	0.5%	LOTION / TOPICAL		Approved before 1982
A080443-003	NUTRACORT	HYDROCORTISONE	1%	LOTION / 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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080443-002	NUTRACORT	0.5%	LOTION / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080443-003	NUTRACORT	1%	LOTION / TOPICAL	Approved before 1982	`74a2ff9319b5…`

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 16 of 19 · 377 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense anti itch	HYDROCORTISONE	A-S Medication Solutions	072dd455-24a5-4a44-aaef-d3e137d005a6	2024-09-26	Warnings	Name fallback generic name: HYDROCORTISONE
AOSI HEALTHCARE	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	f4db90ad-dd62-44f1-9655-2614ed36581e	2024-09-25	Warnings	Name fallback generic name: HYDROCORTISONE
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	83cd9f60-a4c4-4dea-97a7-cd96aade9e88	2024-09-24	Warnings	Name fallback generic name: HYDROCORTISONE
Signature Care Anti Itch	HYDROCORTISONE	Safeway	ed0eb068-3ce6-423d-a7f8-c3456b7f6040	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
members mark hydrocortisone	HYDROCORTISONE	Sam's West Inc	218f0dcd-fa67-4935-8019-ecbbd53ed2f7	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
anti itch	HYDROCORTISONE	Meijer, Inc.	a07496e0-6fc2-4190-8a01-f513134ffb92	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
Exchange Select Hydrocortisone	HYDROCORTISONE	Army & Air Force Exchange Service	1b709db3-7dc1-4756-a8a0-dddda875dc57	2024-09-19	Warnings	Name fallback generic name: HYDROCORTISONE
anti itch	HYDROCORTISONE	Meijer, Inc.	00040bfe-001a-484e-bec0-e21e8b27f369	2024-09-17	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0ae1ba79-3992-4910-b03f-6f9b0f26e300	2024-09-12	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Itch and Rash Cream	HYDROCORTISONE	Wildman Business Group	1f95757d-a434-f02a-e063-6294a90a2d12	2024-09-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE
CVS Health Maximum Strength Scalp Relief Anti-itch	HYDROCORTISONE	CVS Health	b5ef0005-8b76-4205-8be0-db3a7ed7d1c4	2024-08-19	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	fbbbcc67-b46d-d41a-e053-6294a90aa55d	2024-08-08	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	2024-08-07	Adverse reactions	Name fallback generic name: HYDROCORTISONE
CVS Health Hydrocortisone Anti Itch	HYDROCORTISONE	CVS Health	546a1b8a-8254-432a-85c4-38ebee5ad568	2024-08-07	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	e1166b3a-a304-4030-ab51-eb55c6e91afd	2024-08-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	2dda4f32-e0f6-4e8d-8d75-10da5b762790	2024-07-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	47bfae62-bf25-413e-93fc-3c72c901f1a5	2024-07-18	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ac3947c9-5a66-b4e7-e053-2995a90a6f67	2024-07-17	Adverse reactions	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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