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 6 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	b72c47a3-cae3-4b98-ae85-e1313b6fd501	2025-11-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Adult Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	586310f3-0014-4cfc-9d86-961b3fb7aa8c	2025-11-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
childrens Allergy Dye Free Wal Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN CO.	4e64e040-1662-4dc9-b33f-3e119e0b3f7b	2025-11-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime SleepAid	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	3802d57e-7943-c0c2-e063-6394a90a7580	2025-11-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	e1d545dc-9222-4d61-964d-1c781215d7d2	2025-11-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	6178d3a1-0741-49a4-be81-c4f7d29f8b2a	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	R J General Corporation	c46c01c0-29f4-400c-bef5-14b3eb944c51	2025-11-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Target Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	76299495-7259-4bbe-8393-7eabfe22715a	2025-11-05	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e60b0ed-889d-0f17-e063-6394a90a4694	2025-11-03	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	VERITYRX, LLC	42a0e577-a1b6-2c16-e063-6294a90af8e3	2025-11-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Company name: Topco Associates, LLC	7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec	2025-10-31	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	e96ec4d4-53b9-4636-a58c-1a5923a021ad	2025-10-31	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Henry Schein, Inc.	af972e71-62ab-40c6-925a-cbcb4d6720a4	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	SAM'S WEST INC	16592ad7-b7cb-0837-e063-6394a90ae059	2025-10-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	WAL-MART STORES INC.	3652ee94-b762-4100-a305-5acbec5f795a	2025-10-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer Distribution Inc	622b12fa-455c-4432-a9a2-698a929bbd68	2025-10-24	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Sominex	DIPHENHYDRAMINE HYDROCHLORIDE	Medtech Products Inc.	f7858ecf-8498-4465-85d8-3e7814737573	2025-10-23	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nyt Time Sleep Caps	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3f4d063-921d-4503-89a6-26cc9c46b4c9	2025-10-23	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	5a60c923-8bb7-427f-9636-08ed5474f71b	2025-10-21	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
equate NIGHTTIME Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	3d3f2e0c-e141-d49f-e063-6394a90ad0e6	2025-10-21	Warnings	Name fallback 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