Application 070205

Type: ANDA
Sponsor: ALPHARMA US PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDRAMINE	DIPHENHYDRAMINE HYDROCHLORIDE	SYRUP;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
A070205-001	HYDRAMINE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	SYRUP / ORAL			1986-01-28

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070205-001	HYDRAMINE	12.5MG/5ML	SYRUP / ORAL	1986-01-28	`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 6 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
VICKS NyQuil Kids FREE OF ARTIFICIAL DYES AND SUGAR COLD and COUGH plus RUNNY NOSE	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	81ef58de-7e65-446f-98f0-fb88027124ce	2025-12-01	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
nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	b72c47a3-cae3-4b98-ae85-e1313b6fd501	2025-11-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Adult Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	586310f3-0014-4cfc-9d86-961b3fb7aa8c	2025-11-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
childrens Allergy Dye Free Wal Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN CO.	4e64e040-1662-4dc9-b33f-3e119e0b3f7b	2025-11-25	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime SleepAid	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	3802d57e-7943-c0c2-e063-6394a90a7580	2025-11-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	e1d545dc-9222-4d61-964d-1c781215d7d2	2025-11-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	6178d3a1-0741-49a4-be81-c4f7d29f8b2a	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	R J General Corporation	c46c01c0-29f4-400c-bef5-14b3eb944c51	2025-11-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Target Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	76299495-7259-4bbe-8393-7eabfe22715a	2025-11-05	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e60b0ed-889d-0f17-e063-6394a90a4694	2025-11-03	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	VERITYRX, LLC	42a0e577-a1b6-2c16-e063-6294a90af8e3	2025-11-02	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Company name: Topco Associates, LLC	7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec	2025-10-31	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	e96ec4d4-53b9-4636-a58c-1a5923a021ad	2025-10-31	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Henry Schein, Inc.	af972e71-62ab-40c6-925a-cbcb4d6720a4	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.