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 14 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	4cd8aee3-5522-434b-a1b1-9591bed3e9a6	2024-08-04	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
dg health allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, LLC	71445443-34bd-4d8c-b9c8-e7c3b8d4c832	2024-07-19	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b05acd16-21cb-4ee0-afa0-8f7d59166435	2024-07-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	10ebc7f8-dc8a-4640-8f87-d0d073998fd5	2024-07-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	b173cc2c-7c4c-4f9e-a920-c71bc256ec1e	2024-07-18	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
careone nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	14803f99-52c7-4324-b64c-971906144739	2024-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Betr sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	Live Betr LLC	8c2d5514-62c1-4e98-8412-20534365b934	2024-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
careone allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	ed4038fc-ab39-4567-9961-2b390b91b126	2024-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Topcare childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	6b784cde-3152-4421-a825-dd1fc601aa7a	2024-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
topcare sleep aid nighttime	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	30284271-0411-4abf-bc62-d956dc794432	2024-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
dg health sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp Inc	038c1b4e-43f5-4370-896b-97da1b0a89ca	2024-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
welby allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Aldi Inc	73e1d377-0daf-4fd5-9754-c11dc3e24834	2024-07-16	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
basic care allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	7d237d37-21c7-476d-a8b7-d91ea1b472ee	2024-07-16	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Berkley and Jensen Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC	b52fc311-8853-4116-941b-8be35456abba	2024-07-16	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Publix Super Markets Inc	23a98385-28cc-4fac-8c87-b3ced8106532	2024-07-16	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
good sense nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	ba2adc30-0301-4d53-bce6-fc8b7e34b076	2024-07-10	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
AXIV Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1cd2a6f1-31ad-e507-e063-6394a90aba58	2024-07-09	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	TARGET CORPORATION	135d2212-2122-b7a1-e063-6294a90aa5f5	2024-06-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Dimetapp Nighttime Cold and Cough	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	179115ad-d610-99b2-e063-6294a90ae711	2024-06-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	7848bb09-2af8-47f6-b32d-96635a750a55	2024-04-29	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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