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 8 of 19 · 377 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	HYDROCORTISONE	Encube Ethicals, Inc.	969cd576-82d3-4662-bbc1-3587a1f6a564	2025-11-10	Warnings	Name fallback 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 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
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 generic 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
Gelmicin Hydrocortisone with Aloe	HYDROCORTISONE	United Exchange Corp.	bb64eca4-799d-4711-e053-2995a90af403	2025-10-21	Warnings	Name fallback generic name: HYDROCORTISONE
Family Care Anti-Itch	HYDROCORTISONE	United Exchange Corp.	8e4d46d8-7084-0666-e053-2995a90ad520	2025-10-21	Warnings	Name fallback generic name: HYDROCORTISONE
Quadrydern	HYDROCORTISONE	Productos Zapotol Corp	a087ad4d-9a65-19c3-e053-2995a90ab341	2025-10-21	Warnings	Name fallback generic name: HYDROCORTISONE
Family Care Anti-Itch	HYDROCORTISONE	United Exchange Corp.	deb09e89-9794-89a7-e053-2a95a90abdf8	2025-10-20	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Intensive Healing	HYDROCORTISONE	Chattem, Inc.	bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c	2025-10-20	Warnings	Name fallback generic name: HYDROCORTISONE
Quality Choice	HYDROCORTISONE	Chain Drug Marketing Association, Inc.	24c3eb99-92ac-658c-e063-6394a90ab51f	2025-10-16	Warnings	Name fallback generic name: HYDROCORTISONE
Vanicream HC Anti-Itch	HYDROCORTISONE	Pharmaceutical Specialties, Inc.	28b06507-27a5-2cb1-e054-00144ff8d46c	2025-10-14	Warnings	Name fallback generic name: HYDROCORTISONE
Anti-itch	HYDROCORTISONE	Medline Industries, LP	b0947381-c0db-4253-ab40-3d45603ae65d	2025-10-09	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	CVS PHARMACY, INC	b3bdff5e-37fe-442a-a370-7b19799ea781	2025-10-07	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	dc220e63-f9b2-47ea-b8ed-940902a130bf	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	e4f22e9c-cf38-473a-8f7d-8da7fd696f76	2025-10-02	Adverse reactions	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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