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 43.

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 · 129 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	N005845-001	BENADRYL	50MG	CAPSULE / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N005845-004	BENADRYL	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N005845-007	BENADRYL	25MG	CAPSULE / ORAL	Approved before 1982	`84e616aacf4f…`
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…`

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 15 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dye Free Allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	f1a33c2f-2330-43f3-8026-de21808aec66	2024-04-22	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Dimetapp Cough and Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	15b0f5ff-202a-d19f-e063-6394a90af2b8	2024-04-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Dye Free Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	1c4d09ed-4e0f-430d-b17f-6a23f996a55d	2024-04-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ec691492-a295-4b48-a1a3-5824931efa97	2024-04-09	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	6fe6fe2d-4405-4e7a-a2ed-5eb367d52842	2024-04-05	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Gland Pharma Limited	eeb70724-065c-4a73-8e2e-d6b2a625e8d4	2024-03-22	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2	2024-03-12	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA Health First	738f2ce3-520c-b3a2-e053-2a91aa0af324	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	40e73317-5126-4961-8f28-60899ffbec5a	2024-02-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	2424fb95-06e2-49e7-aea0-7797a37aef4d	2024-02-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	d9f650b5-3c27-17cf-e053-2995a90af48a	2024-02-12	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc	f5b609e1-e63b-2e3b-e053-2995a90a76b9	2024-02-12	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
good sense allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	2cfa69b4-e33f-442a-a6df-b021b041da14	2024-02-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Kroger Nighttime Sleep Aid CAPLET	DIPHENHYDRAMINE HYDROCHLORIDE	The Kroger Co.	f0f3f58d-9457-4697-98e6-ef52d350cf67	2024-01-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	ad437177-08eb-4811-883f-ac543d5bc58c	2024-01-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Sleep-Aid Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	4283558d-62df-4297-bc85-a4e06681a920	2024-01-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	af5053d8-ba02-4cdf-877f-8c1e368dafe0	2024-01-10	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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