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 7 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CARDINAL HEALTH	6fe34d05-84a4-4254-aea6-77b52122ea18	2025-10-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
LEADER Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CARDINAL HEALTH	68c79c47-11bf-4b51-ace0-723cac7a4620	2025-10-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
InstaRelief Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	DXM Pharmacuetical, Inc.	e0459e71-32dd-4715-b103-bb14db42c5f3	2025-10-06	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3dd5b783-5b64-24b5-e063-6394a90ab4ee	2025-10-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Xpect Extra Strength Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cintas Corporation	a373b2c3-5c58-4b64-9358-bdf42dfce08c	2025-09-24	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3d71d306-893a-e73a-e063-6394a90a0a3b	2025-09-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
AXIV Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1323a67c-b9c5-038c-e063-6394a90a5e6b	2025-09-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
AXIV - VroZzz	DIPHENHYDRAMINE HYDROCHLORIDE	Vivunt Pharma LLC	131a60cf-02ec-5a5b-e063-6294a90abd1f	2025-09-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Medique Diphen	DIPHENHYDRAMINE HYDROCHLORIDE	Unifirst First Aid Corporation	b61ee2e0-2543-447d-9fc4-23363d46ce04	2025-09-08	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Dye Free Wal Dryl Allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	53e6f72d-15a4-4efe-8b1f-5753fed53df8	2025-09-08	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
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 brand name: DIPHENHYDRAMINE HYDROCHLORIDE 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
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

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