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 4 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZzzQuil Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	e441c952-cd48-4159-ada2-271ca7541600	2026-02-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	5af966ae-535b-492b-ba2c-eeb4e40be959	2026-02-11	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	1d6c23d7-d1dc-4cba-8600-5762c18a0e27	2026-01-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	32074a31-326b-4aaf-e063-6394a90a0d40	2026-01-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	335b6ddd-fdc8-1120-e063-6394a90add41	2026-01-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0e45d0e8-3741-7cee-e063-6394a90a2de5	2026-01-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	335b09c6-ee5d-ebdf-e063-6294a90abd12	2026-01-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	32033991-a4f0-f767-e063-6394a90a0b06	2026-01-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	90506598-046f-48d3-b8f5-d6ead0333812	2026-01-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DORMMY-LON	DIPHENHYDRAMINE HYDROCHLORIDE	Haendel Farma, S.A. de C.V.	562db961-83cb-4b74-9f34-fecee2c1be17	2026-01-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Prodose, Inc.	c4bc3efd-8ca8-22fe-e053-2a95a90aed45	2026-01-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b9fbf917-12b7-770f-e053-2995a90afe93	2026-01-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	f000d0b5-8ee8-4db0-99fe-aae5ed20c98e	2026-01-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	37853689-c9ca-4bc7-9c5b-4a68b8d778be	2026-01-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Dimetane	DIPHENHYDRAMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	2026-01-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Walgreen Itch Relief Gel	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	5aca3297-406f-4165-9895-c58ccffb374f	2026-01-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Quality Choice Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	4b86101c-00f8-4ede-807f-db4273b37b8d	2026-01-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	62edde3d-b41b-40fc-ac18-b749035de831	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Unisom SleepMelts Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chattem, Inc.	9105f4f1-7f94-408d-a025-83afb68dc9f0	2026-01-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e608643-1a74-b474-e063-6294a90ad2e0	2026-01-13	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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