Application 018066

Type: NDA
Sponsor: CHATTEM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UNISOM	DOXYLAMINE SUCCINATE	TABLET;ORAL	25MG	Yes	Yes

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
N018066-001	UNISOM	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL		RLD, RS, 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	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018066-001	UNISOM	25MG	TABLET / ORAL	RLD, RS, 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 1 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	H E B	17667c28-b61e-4974-8736-5de59f69b3b0	2026-07-09	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep-Aid	DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. DBA Leader	96e8d6df-e717-4ffc-9502-498024c9665f	2026-07-09	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Nocto Sleep Aid	DOXYLAMINE SUCCINATE	Belmora LLC	d255309b-0023-48fe-890f-6a4fe04dbb85	2026-07-09	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Vicks NyQuil Allergy	DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	559149ac-1784-c677-e063-6294a90a0673	2026-07-01	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Vicks NyQuil ALLERGY	DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	2f9b3bbb-4494-065d-e063-6294a90afcd2	2026-06-22	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Vicks NyQuil Kids ALLERGY	DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	2f9a6d65-f849-af0a-e063-6394a90ae435	2026-06-22	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Amerisource Bergen	ea842bc4-9788-49a9-a7e1-d6e3dd61056a	2026-06-15	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6d6e47df-a965-4813-8414-9841ed2f9e0c	2026-06-15	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
sleep aid	DOXYLAMINE SUCCINATE	Rite Aid Corporation	4b5fdb06-f205-4424-b4cb-dddef921485b	2026-05-27	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	009df4c9-a524-4b8f-be7a-52c521e68ff1	2026-05-18	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	Strategic Sourcing Services LLC	eddec8bc-2bed-4bc5-a1c2-39424a699838	2026-05-13	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	71e0cef1-6195-4b67-9c1f-b4e5fbeae53c	2026-05-13	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
sleep aid	DOXYLAMINE SUCCINATE	Walgreen Company	489ee606-15f4-4032-a62b-35c8844f1a26	2026-05-08	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
nighttime sleep aid	DOXYLAMINE SUCCINATE	HyVee Inc	95b12a14-21ee-431d-a892-46f8cdca2d7a	2026-04-15	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	005b5ad8-d762-46b5-a7a5-e0ff11ba936a	2026-04-06	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Better Living Brands, LLC	92827089-88d5-4f4e-bcbe-3ca6d94ee96c	2026-03-27	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	Meijer Distribution Inc	96a7c284-4666-4dac-b71e-9433f62580ad	2026-03-27	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	918ad808-ccfd-429f-9052-19905a634606	2026-03-27	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Unisom SleepTabs	DOXYLAMINE SUCCINATE	Chattem, Inc.	7ae32d74-76a0-47e2-9e5c-812426413c4e	2026-03-25	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	Meijer Distribution Inc	de0a6f68-6988-44df-9fab-b87620fd32e8	2026-03-24	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
41167-0060	Unisom SleepTabs	Doxylamine Succinate	Chattem, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72774	SUPPL	2022-12-05
72764	SUPPL	2022-12-02
33410	SUPPL	2013-09-24
14009	SUPPL	2013-09-13
14008	SUPPL	2002-05-30
14007	SUPPL	2002-05-30