Application 080727

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 1.

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
A080727-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080727-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	Approved before 1982	`cb3db0bc1861…`

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 4 of 17 · 332 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	462ca6cd-8eec-09df-e063-6294a90ac880	2026-01-13	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED	AMZ789 LLC	12dd2419-b2e0-5466-e063-6394a90a4221	2026-01-07	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Prodose, Inc.	3b1ea33b-8460-31cf-e063-6394a90a5534	2025-12-31	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SleepAid Softgels	DIPHENHYDRAMINE HYDROCHLORIDE	PIONEER LIFE SCIENCES, LLC	c1dab616-c3ff-4d0a-be13-e8dc6b1a26cc	2025-12-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	a5ceab90-6885-4f3a-b001-97679e03c01b	2025-12-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
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
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AID	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	468fa756-1ed6-4652-e063-6294a90a67ea	2025-12-22	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AID	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	468ff5c6-a6eb-b116-e063-6294a90a84e8	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	REMEDYREPACK INC.	5bbbd6e5-4d0a-4380-bbd3-3313ff26cda0	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride 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
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2025-12-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Application 080727

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#