Application 087978

Type: ANDA
Sponsor: LNK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	CAPSULE;ORAL	50MG	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
A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL			1983-01-27

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	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087978-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	1983-01-27	`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 11 of 17 · 328 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	f99cc210-b946-42a2-9164-8aa5308c5418	2024-12-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
RIGHT REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	b4fc014c-7c5f-46a4-bf13-57103b6fa018	2024-12-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	beb34c94-8370-e97d-e053-2995a90a59cc	2024-12-06	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Somnapure Clinical Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Force Factor Brands LLC	063517c0-bcb1-46dd-85f1-bbb2f24274ef	2024-12-06	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	3ef6d155-b95b-4b30-87a8-8ed811b1520f	2024-12-03	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	c280cf02-ebb2-4847-a66d-d02aff3ea0c9	2024-12-02	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	53b15e75-9efd-4b4b-834b-6e9f12c60108	2024-12-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc.	6dfbb8ba-0cdb-57a2-e053-2991aa0a54e0	2024-12-02	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc	f4468840-e17c-6888-e053-2995a90a04a0	2024-12-02	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc.	6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f	2024-12-02	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc	b45296a9-e3f0-a4cb-e053-2995a90a1686	2024-12-02	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Benadryl DYE-FREE ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	2024-11-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	2024-11-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	236ff457-0ec1-9c49-e063-6394a90a707a	2024-11-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	50d74111-6d1b-4681-a264-f7e550320259	2024-11-25	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	efb05387-72c0-4643-8541-b7990c202ce6	2024-11-25	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	508a65ee-42fa-4c0b-b24d-9faac6b0eba7	2024-11-24	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	de2a64ce-c169-4162-b79e-d3809bea2147	2024-11-22	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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