Application 019440

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UNISOM	DOXYLAMINE SUCCINATE	CAPSULE;ORAL	25MG	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
N019440-001	UNISOM	DOXYLAMINE SUCCINATE	25MG	CAPSULE / ORAL			1986-02-05

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	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019440-001	UNISOM	25MG	CAPSULE / ORAL	1986-02-05	`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 3 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
up and up nighttime sleep aid	DOXYLAMINE SUCCINATE	Target Corporation	24a0144d-cbfc-4d2f-873d-86adfa0468ca	2025-04-02	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
CareOne Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	American Sales Company	f8bfc874-53be-41e8-b59c-d538825761a8	2025-04-01	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
berkley and jensen sleep aid	DOXYLAMINE SUCCINATE	BJWC	25f468a9-71d4-40f2-97bb-1c3ff5d4b728	2025-03-31	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
topcare sleep aid	DOXYLAMINE SUCCINATE	Topco Associates LLC	c8b24ed8-34a1-4857-8fcb-6e3f9d407903	2025-03-26	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
good sense sleep aid ultra	DOXYLAMINE SUCCINATE	L. Perrigo Company	6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd	2025-03-06	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
dg health sleep aid	DOXYLAMINE SUCCINATE	Dolgencorp Inc	a4c6b400-7fa6-4ad1-9d39-d34621eb91a6	2025-03-05	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Night Time Sleep Aid	DOXYLAMINE SUCCINATE	Advanced Rx LLC	db8b730a-1553-4682-96bf-41e670ed0347	2025-02-26	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
TopCare Sleep Aid	DOXYLAMINE SUCCINATE	Topco Associates LLC	15dc89c4-b7ce-4d36-8107-f501daaf289b	2025-02-16	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
sleep aid	DOXYLAMINE SUCCINATE	Rite Aid Corporation	ef5be1f7-a7d6-4a8a-b243-902e84635aba	2024-03-28	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Topcare Sleep Aid	DOXYLAMINE SUCCINATE	Topco Associates LLC	d0295e0b-aba8-4cc7-b83c-b494d552413b	2024-03-28	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE

Reported adverse events (FAERS/openFDA)#

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