Nighttime Sleep Aid

Product NDC: 37835-831
11-digit product format: 378350831
Labeler code: 37835
Product ID: 37835-831_5cebc512-d757-197b-e063-6394a90ae9fe
Type: HUMAN OTC DRUG
Nonproprietary name: Doxylamine succinate
Dosage form: TABLET
Route: ORAL
Labeler: Bi-Mart
Application: ANDA040564
Marketing category: ANDA
Marketing start: 2025-06-01
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

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
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 · 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	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Night Time Sleep Aid	DOXYLAMINE SUCCINATE	Advanced Rx LLC	db8b730a-1553-4682-96bf-41e670ed0347	2025-02-26	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	NIGHTTIME SLEEP AID	Family Dollar Stores, Inc	d91f0c21-28f0-4d32-a1d2-fae406b90bf7	2023-07-25	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	NIGHTTIME SLEEP AID	Allegiant Health	3761182c-275b-40f3-a262-9ef5f5a80723	2023-03-16	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	Sample	Exclude flag	Status
37835-831-48	37835083148	48 TABLET in 1 BOTTLE (37835-831-48)	48 tablet	2025-06-01	No	No	Current