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 10 of 19 · 377 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	a0fde5c9-afb2-76a9-e053-2995a90af3e8	2025-07-21	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone anti-itch plus	HYDROCORTISONE	Wal-Mart Stores, Inc.	a0c6e180-b385-4a9b-a9cf-84a551f533d0	2025-07-16	Warnings	Name fallback generic name: HYDROCORTISONE
Itch Relief	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	ae4b7cd6-8b5d-4d25-86f9-72260638bb94	2025-07-16	Warnings	Name fallback generic name: HYDROCORTISONE
Freds Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	FRED'S, INC.	7502eebe-11c5-4e9e-b427-b87180a84349	2025-07-16	Warnings	Name fallback generic name: HYDROCORTISONE
TopCare Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	Topco Associates LLC	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	TARGET Corporation	72c3889c-b743-4728-a315-6e4063e00200	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
Shopko Hydrocortisone Maximum Strength	HYDROCORTISONE	Shopko Stores Operating Co., LLC	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
Freds Hydrocortisone with Aloe	HYDROCORTISONE	FRED'S, INC.	076503bf-8238-4739-bb1c-c385e72f8a96	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
Shopko Hydrocortisone	HYDROCORTISONE	Shopko Stores Operating Co., LLC	92bcbde3-401a-4301-854e-c352852317d6	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
FifthPulse Hydrocortisone 1oz	HYDROCORTISONE	Front Pharmaceutical PLC	39fae2a4-902e-3c88-e063-6394a90acbd5	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
TopCare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	bd3585fa-3b48-49b7-8ad1-749bf1e31ed5	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
FifthPulse Hydrocortisone 4oz	HYDROCORTISONE	Front Pharmaceutical PLC	39fb29c8-6a28-e87e-e063-6294a90a78da	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
Equate Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	Wal-Mart Stores Inc.	635b49c4-54d2-4b6d-bee8-851fc2c7ca9c	2025-07-14	Warnings	Name fallback generic name: HYDROCORTISONE
Avedana Hydrocortisone Cream with Aloe	HYDROCORTISONE	Unipack LLC	2a55c426-39b4-4d94-b6b4-6c548c9685e9	2025-07-13	Warnings	Name fallback generic name: HYDROCORTISONE
CVS Cortisone	HYDROCORTISONE	CVS Pharmacy	87631be8-94b8-4718-858d-d2f30e636cce	2025-07-10	Warnings	Name fallback generic name: HYDROCORTISONE
TopCare Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	Topco Associates LLC	c40e8e1d-d6d7-4880-99d3-011b97a5e4f3	2025-07-10	Warnings	Name fallback generic name: HYDROCORTISONE
Live Better Hydrocortisone with Aloe	HYDROCORTISONE	The Great Atlantic & Pacific Tea Company	044e6ee2-98a6-4802-b33d-78b8551356c4	2025-07-10	Warnings	Name fallback generic name: HYDROCORTISONE
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	AmerisourceBergen	f36acdb8-a526-4bb7-a557-e1dcbbc1cf45	2025-07-08	Warnings	Name fallback generic name: HYDROCORTISONE
Good Neighbor Pharmacy Hydrocortisone with Aloe	HYDROCORTISONE	AmerisourceBergen	0c544792-63d9-400c-9888-207c44fdc75e	2025-07-08	Warnings	Name fallback generic name: HYDROCORTISONE
Good Neighbor Pharmacy Hydrocortisone	HYDROCORTISONE	AmerisourceBergen	58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf	2025-07-08	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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