Application 080596

Type: ANDA
Sponsor: VALEANT PHARM INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	CAPSULE;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080596-001	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	Approved before 1982	`cb3db0bc1861…`

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 17 · 334 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	2025-06-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	c0270298-e7c5-e500-e053-2995a90aed23	2025-06-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	bc019c9e-8fac-5fd3-e053-2a95a90a7ccd	2025-06-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walmart Inc.	24ff91f2-02db-56a2-e063-6394a90a31c9	2025-06-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Morning Star OTC	f4ff84b3-bb0c-4900-8ba4-6d1b90394782	2025-06-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Simply Sleep	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	2025-06-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	8559be55-8b00-4353-8e26-b5dff2ada806	2025-05-30	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Somnitabs	DIPHENHYDRAMINE HYDROCHLORIDE	HARRIS TEETER	0ce0cb28-5ea1-43e5-8da1-02128b9989a5	2025-05-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	2364f152-657e-4849-96b1-b51b3c77bf86	2025-05-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Avenacy, LLC	00f862aa-6917-45c7-b6aa-1bebb0a45e14	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
BACTIMICINA CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	DLC Laboratories, Inc.	eaf554d4-a758-4ed6-bec5-d6cbfedae408	2025-05-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Safeway, Inc.	c639a36d-c683-4a4d-90b7-eadec7464aa2	2025-05-08	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	54bdb6bc-622c-412a-8365-a1b1c968e13e	2025-05-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	66a2fd60-1757-45cc-a195-ecb9241dca2a	2025-04-24	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
meijer Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bd85bc3-e600-583d-e063-6294a90a7be1	2025-04-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	f4f0c26b-dad0-47a1-a9e7-6558c11254c0	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	9382c976-3067-4923-a38f-101d1c481e97	2025-04-11	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	829bbcbf-fb27-4484-aff6-a7e7467670af	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	6d1aa0e2-036d-4382-a458-fc0300dba7cb	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Application 080596

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#