Application 040140

Type: ANDA
Sponsor: HOSPIRA

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 42.

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
A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			1998-11-20

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	1998-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040140-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		1998-11-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A040140-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040140-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040140-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040140-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040140-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040140-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040140-001	AP	1	`8869cabd3fbd…`
2019-12-14 00:12 UTC	2019-12	A040140-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040140-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040140-001	AP	1	`ea99ee380514…`

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 1 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCL	DIPHENHYDRAMINE HYDROCHLORIDE	Redmont Pharmaceuticals, LLC	d8944f3c-acef-4ebe-9633-7d641ae95edf	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DG Health Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp Inc	ed754d5c-74e1-4dee-a5c5-10ccec1b81db	2026-08-03	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer Distribution Inc	f1e83e43-011c-4470-bd55-fb2818a9fc84	2026-07-30	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Sportpharm LLC	e5af2dd2-cc91-46c7-bdb9-97a7cdddcb69	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	879a7804-f3d4-4a3d-bc92-b473499d6c95	2026-07-17	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ADWE dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	ea3a51af-3025-497f-8cd7-e99391b0d06f	2026-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	d38f47ea-7fda-170b-e053-2995a90adc82	2026-07-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	f808ee14-fccf-4abe-b53a-a40b0b3bba03	2026-07-04	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Select Consumer Group	55d10292-e673-9896-e063-6294a90a5674	2026-07-04	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	0ccbc301-6833-bbc4-e063-6294a90aad92	2026-06-29	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	31755678-825c-b84a-e063-6294a90a5a83	2026-06-27	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	319e84fd-4033-f5eb-e063-6394a90aa2f3	2026-06-27	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11	2026-06-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Goodmeds Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	37533188-8c91-428b-a796-c5afd9e4959f	2026-05-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9713d8ee-6ab2-2fdf-e053-2a95a90a9e19	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	50df93bf-fe72-48f6-a02e-ea9a313d47c2	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	51bb483f-3fe6-8a94-e063-6394a90acf7d	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	bfeae100-e2d1-4607-be3b-2d9b15cd4f7f	2026-05-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-2290	Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2290	Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2290	Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2290	Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1218	DIPHENHYDRAMINE HCI	DIPHENHYDRAMINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1218	DIPHENHYDRAMINE HCI	DIPHENHYDRAMINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1218	DIPHENHYDRAMINE HCI	DIPHENHYDRAMINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-290	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	General Injectables and Vaccines	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42585	ORIG	2004-12-08
29894	ORIG	1998-11-20