Application 005845

Type: NDA
Sponsor: MCNEIL CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	CAPSULE;ORAL	50MG	No	No
004	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	ELIXIR;ORAL	12.5MG/5ML	No	No
007	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	CAPSULE;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N005845-001	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982
N005845-004	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982
N005845-007	BENADRYL	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`

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 2 of 17 · 332 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9713d8ee-6ab2-2fdf-e053-2a95a90a9e19	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	50df93bf-fe72-48f6-a02e-ea9a313d47c2	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	51bb483f-3fe6-8a94-e063-6394a90acf7d	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	bfeae100-e2d1-4607-be3b-2d9b15cd4f7f	2026-05-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	047102c4-3d03-4b2d-961d-0ac75980147b	2026-05-06	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	d32d074a-f1b6-4a9a-8e10-e19f0e67c61b	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Savings Distributors LLC	8d59d121-62a8-c43b-e053-2a95a90a5847	2026-05-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0203d919-dc1f-cca0-e063-6394a90aa1aa	2026-04-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Tecnu Calagel	DIPHENHYDRAMINE HYDROCHLORIDE	Tec Laboratories Inc.	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	2026-04-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	5a5c5f33-5b70-465d-a38b-6f518af09788	2026-04-13	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nightime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC.	202bb1ff-3273-4872-e063-6294a90abebb	2026-04-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Wal Dryl Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	09de28cd-fa60-4af7-b7cc-cf74c00a3531	2026-04-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	e24121d2-c9d2-4bbd-869e-eeed7e2bb881	2026-04-08	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Vicks ZzzQuil Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	1be2f00b-5bdd-82e7-e063-6394a90ab9a5	2026-04-06	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	44217a8c-7656-a0f6-e063-6294a90af2ad	2026-03-31	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	eedb421c-0020-4e5f-8b09-26a1cbabb681	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TWIN MED LLC	7b000478-649d-4511-b3e0-eea6995b9784	2026-03-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	01c04bad-3905-4776-b936-7b48ee6699df	2026-03-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	f9a0fb35-46d6-434f-8f9a-425a4bf50e84	2026-03-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Grocery Outlet, Inc.	4454df6a-931f-3f03-e063-6294a90afe73	2026-03-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Application 005845

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#