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 5 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SleepAid Softgels	DIPHENHYDRAMINE HYDROCHLORIDE	PIONEER LIFE SCIENCES, LLC	9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa	2025-12-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	AptaPharma Inc.	b2cef61f-ab54-4a20-a7f7-6d3da4754e8b	2025-12-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CAREALL Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	New World Imports, Inc	f3b177ef-55d5-4525-bf33-99205c414a5b	2025-12-22	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CAREALL Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	New World Imports, Inc	af2f8389-d696-4060-8abd-6eda04e73009	2025-12-22	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SleepAid Softgels	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	963c6925-dfbf-4cdc-8d13-5e10b499c4a9	2025-12-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	6fa4f913-de83-4175-9dad-0dedab5b69a1	2025-12-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	ProPharma Distribution	3842d802-9b18-2c5e-e063-6394a90ae763	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	d6947661-a6dd-4bc4-a0ca-932db1840f58	2025-12-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b2	2025-12-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	d337a0e6-09ed-4db0-8883-ec8a5d56bd35	2025-12-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b84f37bc-be37-4f2b-83ee-d7d134184490	2025-12-11	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b	2025-12-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	HEB	91426a5b-dc01-a27b-e053-2a95a90a8ff8	2025-12-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	5015a380-a229-4eff-8e31-528065c6ed64	2025-12-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	caf59320-5b48-4533-bda9-7b03a2fde0b5	2025-12-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	97eb3e4d-06b7-49ed-909b-95b523dcce41	2025-12-05	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Unisom SleepMelts Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f50cc038-0973-4c4b-84a7-1c68f41c2410	2025-12-04	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy Extra Strength Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	30aca3ab-b091-3939-e063-6294a90a9819	2025-12-03	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	048cfa3a-4519-400d-a5ab-ce05c9cc4ec8	2025-11-26	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Dye Free Wal Sleep Z	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN CO.	96948973-09e3-4c05-8982-0494ebeaac4b	2025-11-26	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