7 Select Sleep Aid

Product NDC: 10202-441
Requested package NDC: 10202-441-73
11-digit product format: 102020441
Labeler code: 10202
Product ID: 10202-441_ad6189d6-1737-41dc-aff4-5e33bc266563
Type: HUMAN OTC DRUG
Nonproprietary name: Doxylamine succinate
Dosage form: TABLET
Route: ORAL
Labeler: 7-Eleven
Application: ANDA040167
Marketing category: ANDA
Marketing start: 2014-08-05
Marketing end: 2022-02-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10202-441	10202-441-73	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040167-001	DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL			1996-09-18

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	7 SELECT SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [7-ELEVEN]	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	7 SELECT SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [7-ELEVEN]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	7 SELECT SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [7-ELEVEN]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	7 SELECT SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [7-ELEVEN]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	7 SELECT SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [7-ELEVEN]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	7 SELECT SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [7-ELEVEN]	2

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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sleep aid	DOXYLAMINE SUCCINATE	Rite Aid Corporation	ef5be1f7-a7d6-4a8a-b243-902e84635aba	2024-03-28	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
Topcare Sleep Aid	DOXYLAMINE SUCCINATE	Topco Associates LLC	d0295e0b-aba8-4cc7-b83c-b494d552413b	2024-03-28	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167

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
10202-441-73	10202044173	16 BLISTER PACK in 1 CARTON (10202-441-73) > 1 TABLET in 1 BLISTER PACK	16 blister pack	2014-08-05	2022-02-28	No	No	Current