Application 080763

Type: ANDA
Sponsor: ALPHARMA US PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	HYDRAMINE	DIPHENHYDRAMINE HYDROCHLORIDE	ELIXIR;ORAL	12.5MG/5ML	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
A080763-002	HYDRAMINE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR / 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	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080763-002	HYDRAMINE	12.5MG/5ML	ELIXIR / 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 1 of 17 · 333 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc	303d7651-9c8f-4a14-9f2c-7181fa0f003e	2026-09-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OF	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	01906eed-78ee-f2a1-e063-6294a90a809b	2026-09-08	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	a26d63db-8841-47a4-ae09-ac736d7ec357	2026-09-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2bea22e9-34b6-4961-94bb-5600dd90e891	2026-09-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger	514aa6b5-c33b-494c-e063-6294a90a7ace	2026-08-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	298e9164-e378-4b39-a944-bfc8f8baa4de	2026-08-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	HyVee Inc	496ce4ba-08a9-ee99-e063-6294a90ac9a7	2026-08-21	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9713d8ee-6ab2-2fdf-e053-2a95a90a9e19	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	a575a914-14a0-442c-a504-ac7a0aa0ac77	2026-08-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	e8785ba8-e53e-491e-bbfe-04e860f36131	2026-08-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	9f944edc-a317-4967-ae54-67b5d183591b	2026-08-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2026-08-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	4b6fc81e-e3ba-4a36-834c-82766311aa73	2026-08-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	8db277e2-9d98-40b6-8000-a51c57fb4ece	2026-08-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	519c86dd-fa86-5de2-e063-6394a90a462b	2026-08-14	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	6fb6cfde-30a6-419c-973d-8abdc72611ed	2026-08-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	887cabe5-46d0-4f4e-8f5a-2cfdbc157b58	2026-08-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Winco Foods Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	a1367804-37c9-4906-858f-8feeb748d8d3	2026-08-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
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

Application 080763

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#