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 9 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 brand name: Benadryl 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
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 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 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 generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	2d64f5c2-dfa9-e5f5-e063-6294a90a0711	2025-03-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	fc574e74-1fdc-4a61-a1ed-492ae43faed2	2025-02-21	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
meijer NIGHTTIME Sleep Aid SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bede4cd-bf55-8b84-e063-6394a90aa5c9	2025-02-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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