Application 040498

Type: ANDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2005-07-12

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2005-07-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2005-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040498-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2005-07-12	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040498-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040498-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040498-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040498-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040498-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040498-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040498-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040498-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040498-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040498-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040498-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040498-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040498-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040498-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040498-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040498-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040498-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040498-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040498-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040498-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040498-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040498-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040498-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040498-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040498-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040498-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040498-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040498-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040498-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040498-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040498-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040498-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040498-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040498-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040498-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040498-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040498-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040498-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040498-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040498-001	AP	1	`f41ea6bd6efb…`

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 16 · 308 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 brand name: Diphenhydramine Hydrochloride 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 brand name: Diphenhydramine hydrochloride 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 brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride 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
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 brand name: Diphenhydramine Hydrochloride 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 brand name: Diphenhydramine Hydrochloride 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 brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals, Inc.	2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99	2024-12-26	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-124	Diphenhydramine Hydrochloride	diphenhydramine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-124	Diphenhydramine Hydrochloride	diphenhydramine hydrochloride	Mylan Institutional LLC	ANDA	Current