Application 006146

Type: NDA
Sponsor: MCNEIL CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	No	No
002	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N006146-001	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		Approved before 1982
N006146-002	BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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 3 · 86 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	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N006146-002	BENADRYL	50MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N006146-002	BENADRYL	50MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N006146-001	BENADRYL	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N006146-002	BENADRYL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`

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 10 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	DOLGENCORP, LLC	be2207b7-b8f8-7fba-e053-2a95a90abd16	2025-02-10	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	f40bfdfc-1cb4-4604-9790-fb8d1d5173c6	2025-01-31	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
BENADRYL Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	224ba2a3-1a93-29c8-e063-6394a90a9bef	2025-01-30	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
GOOD REMEDIES Allergy Relief SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	26a02737-2cfd-769f-e063-6394a90af352	2025-01-22	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	971515fa-b4d2-1197-e053-2995a90a838d	2025-01-03	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief Caplet	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	126c05e7-2cd9-47d3-96c3-82305714e1db	2025-01-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep-Aid Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	8b0fa259-6702-4667-bac6-f7d0b0839ae0	2025-01-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Sleep Aid Nighttime	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	9f1c078d-e537-4ec0-8ae9-54c98282be29	2024-12-31	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb	2024-12-30	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals Inc.	f184b2aa-91a4-44f9-b688-d4e318181984	2024-12-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals, Inc.	2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99	2024-12-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Sagent Pharmaceuticals	6533e629-a27b-4489-8fa3-7de32fbf809e	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Harris Teeter Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	4ebe1d94-bb15-4250-a4c2-8cd45743c7dd	2024-12-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Kroger Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	THE KROGER CO	976bfdcf-2110-486c-aa6e-cd2067334cdc	2024-12-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Discount Drugmart Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart, Inc	1ac281e1-22ea-42f8-98fe-ab3d5ff9a208	2024-12-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
TopCare Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	4c50233e-1dcb-427d-ba63-1538cf370061	2024-12-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AmerisourceBergen Drug Corp	e4610d53-4459-43a0-9351-f0ac8586df60	2024-12-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
equate nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	6e162152-b414-470c-b146-649d99870577	2024-12-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Quality Choice Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	e8b2858b-a737-c500-e053-2995a90adba6	2024-12-16	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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