Nighttime Sleep Aid

Product NDC: 55319-439
11-digit product format: 553190439
Labeler code: 55319
Product ID: 55319-439_02992add-e605-4c92-a970-3b398c497024
Type: HUMAN OTC DRUG
Nonproprietary name: Nighttime Sleep Aid
Dosage form: TABLET
Route: ORAL
Labeler: Family Dollar Stores, Inc
Application: ANDA040564
Marketing category: ANDA
Marketing start: 2023-10-31
Substance: DOXYLAMINE SUCCINATE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-439-16	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-439-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55319-439-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55319-439-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55319-439-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55319-439-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55319-439-16	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55319-439-16	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55319-439-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nighttime Sleep Aid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYLAMINE SUCCINATE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1101446	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d91f0c21-28f0-4d32-a1d2-fae406b90bf7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-439-16	2025-01-30	C162847	48780-1	2cef2736-90db-d83d-e063-dadaa90ab31f	439- Nighttime Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-439-16	Nighttime Sleep Aid	2 in 1 CARTON	TABLET	2		9
55319-439-16	Nighttime Sleep Aid	8 in 1 BLISTER PACK	TABLET	8		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-439	NIGHTTIME SLEEP AID TABLET [FAMILY DOLLAR STORES, INC]	8	Current NDC, 2 package rows	20231101_d91f0c21-28f0-4d32-a1d2-fae406b90bf7.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1101446	doxylamine succinate 25 MG Oral Tablet	PSN	d91f0c21-28f0-4d32-a1d2-fae406b90bf7	9
1101446	doxylamine succinate 25 MG Oral Tablet	SCD	d91f0c21-28f0-4d32-a1d2-fae406b90bf7	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55319-439-16	55319043916	2 BLISTER PACK in 1 CARTON (55319-439-16) / 8 TABLET in 1 BLISTER PACK	2 blister pack	2023-10-31	No	No	Current