Nighttime Sleep Aid

Product NDC: 59779-863
11-digit product format: 597790863
Labeler code: 59779
Product ID: 59779-863_20a838b9-f967-400e-8b00-c6d23843b79f
Type: HUMAN OTC DRUG
Nonproprietary name: Doxylamine succinate
Dosage form: TABLET
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA040564
Marketing category: ANDA
Marketing start: 2002-04-11
Marketing end: 2022-07-20
Substance: DOXYLAMINE SUCCINATE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59779-863		D	Discontinued by firm	2026-08-03
excluded package	package	59779-863	59779-863-22	D	Discontinued by firm	2026-08-03
excluded package	package	59779-863	59779-863-46	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59779-863-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59779-863-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59779-863-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59779-863-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59779-863-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59779-863-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59779-863-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59779-863-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59779-863-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59779-863-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59779-863-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59779-863-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59779-863-22	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59779-863-46	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59779-863-22	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59779-863-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59779-863-22	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59779-863-46	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59779-863-22	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59779-863-46	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59779-863-22	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59779-863-46	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59779-863-22	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59779-863-46	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040564-001	DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL			2004-08-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-863-22	EA - Each	59779-863	8d9ac788-39b3-41ae-8c91-1a08adf06a8f	1	2018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	4

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 2 · 24 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	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep-Aid	DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. DBA Leader	96e8d6df-e717-4ffc-9502-498024c9665f	2026-07-09	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nocto Sleep Aid	DOXYLAMINE SUCCINATE	Belmora LLC	d255309b-0023-48fe-890f-6a4fe04dbb85	2026-07-09	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Amerisource Bergen	ea842bc4-9788-49a9-a7e1-d6e3dd61056a	2026-06-15	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6d6e47df-a965-4813-8414-9841ed2f9e0c	2026-06-15	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	009df4c9-a524-4b8f-be7a-52c521e68ff1	2026-05-18	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Strategic Sourcing Services LLC	eddec8bc-2bed-4bc5-a1c2-39424a699838	2026-05-13	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	71e0cef1-6195-4b67-9c1f-b4e5fbeae53c	2026-05-13	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	005b5ad8-d762-46b5-a7a5-e0ff11ba936a	2026-04-06	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Better Living Brands, LLC	92827089-88d5-4f4e-bcbe-3ca6d94ee96c	2026-03-27	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Meijer Distribution Inc	96a7c284-4666-4dac-b71e-9433f62580ad	2026-03-27	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	918ad808-ccfd-429f-9052-19905a634606	2026-03-27	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Unisom SleepTabs	DOXYLAMINE SUCCINATE	Chattem, Inc.	7ae32d74-76a0-47e2-9e5c-812426413c4e	2026-03-25	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Grocery Outlet	bc13c6c1-1706-4f8c-9789-448f7fe4628d	2026-03-18	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Walgreen Company	d812217b-b2f2-4716-92f4-c16bd0768e17	2026-02-11	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	8df4ac6d-f222-4218-9dcc-3df09c91d2ae	2026-01-06	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
SLEEP AID 25mg	DOXYLAMINE SUCCINATE	YYBA CORP	a436f6d2-6d7e-4f0e-b1c3-acc17cbcb64a	2025-12-02	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep-Aid	DOXYLAMINE SUCCINATE	Kroger Company	8b85812e-33a3-4534-bfba-ee4502d11d34	2025-09-23	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Kroger Company	76e1e49d-eb57-4590-8cf8-91f29dbd15c3	2025-08-22	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	CVS PHARMACY	0b08ca81-1d07-4a57-9cbd-72e3a6a37814	2025-08-19	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-863-22	59779086322	3 BLISTER PACK in 1 CARTON (59779-863-22) > 16 TABLET in 1 BLISTER PACK	3 blister pack	2002-04-11	2022-07-20	No	No	Current
59779-863-46	59779086346	1 BOTTLE in 1 CARTON (59779-863-46) > 96 TABLET in 1 BOTTLE	1 bottle	2002-04-11	2022-07-20	No	No	Current