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 8 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	35b78063-e717-2ccb-e063-6394a90a18eb	2025-09-04	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
QUALITY CHOICE NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	3ce00c99-1a9b-41f1-a99a-35e03730dff0	2025-08-23	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Micro Labs Limited	c2981222-1671-4ecd-a5a2-286f0663f1ae	2025-08-23	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
QUALITY CHOICE Childrens Allergy Relief DYE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	644f39d8-7cd6-43dd-9265-546d01d32e8c	2025-08-22	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC (Berkley & Jensen / BJ's)	2f32d32e-e92c-ea57-e063-6394a90a4c39	2025-08-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC (Berkley & Jensen / BJ's)	2f476647-5727-3443-e063-6394a90afd3f	2025-08-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC (Berkley & Jensen / BJ's)	2f477706-0ce2-97b0-e063-6294a90a5c8e	2025-08-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	c0fa4e00-2bd1-4d16-810d-b55f3b827418	2025-08-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Chewable Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2cac72be-4830-ad49-e063-6394a90a7832	2025-08-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health, Inc	26a55d74-f772-5d17-e063-6394a90a5583	2025-08-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	2ea0b2cf-f055-11f6-e063-6394a90a5364	2025-08-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	1b591e27-b00b-41c8-9fe9-c633aba09134	2025-08-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Demoulas Super Markets, Inc	397f5acd-31c0-683e-e063-6394a90a7e54	2025-07-16	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Cabinet Allergy Relief Refill Diphenhydramine HCI	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	d47553a4-ca15-4f0a-8177-d743a5c39cc5	2025-07-03	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Bi-Mart	2e7a9032-67d6-d408-e063-6394a90aca8c	2025-07-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	896ae7b8-cb8d-1aaa-e053-2a95a90a4e1a	2025-06-30	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	483fbd4c-25c7-4553-8c3f-089daca84ae6	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	bb9a82b1-ea7a-4d10-bc00-05013e83c4d3	2025-06-30	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	bb728ceb-8eb0-4192-a8b0-742756819a05	2025-06-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	2025-06-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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