Application 080738

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	CAPSULE;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080738-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`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 16 of 17 · 328 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	9e067482-8735-4476-a82e-438dd24d4289	2024-01-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	DeMoulas Market Basket	d3f35102-94ed-4da0-9c29-312e5468fa05	2023-12-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DeMoulas Market Basket	fd04fb94-f581-4ca2-b7ac-20359093863e	2023-12-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Jet-Asleep Double Strength Night Time Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Bell Pharmaceuticals, Inc.	d053201d-9ae2-47c2-8f07-3e4b4af940b6	2023-12-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Circle K Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	a6a1e3d9-575c-4adf-beb6-c9719de55c67	2023-12-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	b1c849e5-8003-4fd3-811d-6a927523e353	2023-12-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Simpex Pharma Pvt. Ltd	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	2023-11-29	Warnings	Name fallback brand name: diphenhydramine hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	ec2070df-8a8a-4cd1-8830-62655433fb3b	2023-11-05	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6cece6c-23e4-7811-e053-6394a90a106a	2023-11-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HYDROCHLORIDE	Natco Pharma USA LLC	54b64354-ac10-42ff-a53d-96cef933a91a	2023-11-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Armas Pharmaceuticals Inc.	c1cd6138-ca31-4bb5-ae47-2d80d4d54f9d	2023-07-20	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	bf7ab250-38b0-ba29-e053-2a95a90a8f32	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	95fbf4c2-c96e-2d41-e053-2995a90a0d54	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6671c8d0-1f5d-0d77-e053-2a91aa0a7585	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7b9ed8ef-ce21-19e7-e053-2a91aa0a81be	2022-12-10	Warnings, Adverse reactions	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Time-Cap Labs, Inc	ed899055-0cbb-45bd-92c8-cbef2fc7c361	2018-12-17	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Velocity Pharma LLC	73e4f21c-e5ec-42c9-9ec8-118479857057	2018-05-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Velocity Pharma LLC	035454a1-d23b-4faf-8fac-a59fc77ce18c	2018-05-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	dbd8c221-8409-4851-a6b4-c9f5e8e346e7	2017-12-30	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
53808-0238	Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
67046-127	Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Contract Pharmacy Services-PA	ANDA	Current