Topcare Sleep Aid

Product NDC: 76162-159
11-digit product format: 761620159
Labeler code: 76162
Product ID: 76162-159_d7fff893-f18b-4114-91fe-e9c1b1e3bbc6
Type: HUMAN OTC DRUG
Nonproprietary name: Doxylamine Succinate
Dosage form: TABLET
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA040167
Marketing category: ANDA
Marketing start: 2023-06-16
Substance: DOXYLAMINE SUCCINATE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: 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
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 · 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	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…`
2022-10-28 04:53 UTC	2022-10	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040167-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	1996-09-18	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Topcare Sleep Aid
Listing expiration: 2026-12-31

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
d0295e0b-aba8-4cc7-b83c-b494d552413b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76162-159-62	Topcare Sleep Aid	1 in 1 BLISTER PACK	TABLET	1	2
76162-159-62	Topcare Sleep Aid	24 in 1 CARTON	TABLET	24	2
76162-159-67	Topcare Sleep Aid	48 in 1 CARTON	TABLET	48	2
76162-159-67	Topcare Sleep Aid	1 in 1 BLISTER PACK	TABLET	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76162-159	TOPCARE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [TOPCO ASSOCIATES LLC]	2	Current NDC, 4 package rows	20240402_d0295e0b-aba8-4cc7-b83c-b494d552413b.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 · 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	4b5fdb06-f205-4424-b4cb-dddef921485b	2026-05-27	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
sleep aid	DOXYLAMINE SUCCINATE	Walgreen Company	489ee606-15f4-4032-a62b-35c8844f1a26	2026-05-08	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
nighttime sleep aid	DOXYLAMINE SUCCINATE	HyVee Inc	95b12a14-21ee-431d-a892-46f8cdca2d7a	2026-04-15	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
Sleep Aid	DOXYLAMINE SUCCINATE	Meijer Distribution Inc	de0a6f68-6988-44df-9fab-b87620fd32e8	2026-03-24	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
NIGHTTIME SLEEP AID	DOXYLAMINE SUCCINATE	CVS Pharmacy	05050b61-2417-48f0-9478-c39d6a341026	2026-02-27	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
Unisom SleepTabs	DOXYLAMINE SUCCINATE	Chattem, Inc.	f591d52f-5610-4517-a96f-1ed63deb00bc	2026-01-14	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
Good sense sleep aid	DOXYLAMINE SUCCINATE	L. Perrigo Company	f0a0eb93-96e0-432b-9b82-f0e891483be0	2025-11-14	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
Vicks ZzzQuil Ultra	DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	c29f6f9a-7b55-30c3-e053-2995a90a9de7	2025-10-02	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
Basic Care Sleep Aid	DOXYLAMINE SUCCINATE	Amazon.com Services LLC	e09cd229-638b-4065-8325-ed2c1ce2e99d	2025-08-19	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
sleep aid ultra	DOXYLAMINE SUCCINATE	Meijer, Inc.	792632af-01c1-4a9b-99f4-8eb84d0fc389	2025-06-16	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
sleep aid	DOXYLAMINE SUCCINATE	Publix Super Markets Inc	377ebf03-c1d5-4362-98b3-032206df9e8e	2025-05-23	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
good sense sleep aid ultra	DOXYLAMINE SUCCINATE	L. Perrigo Company	300826cf-6d0d-4efb-97aa-aa7dfff3add2	2025-04-02	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
up and up nighttime sleep aid	DOXYLAMINE SUCCINATE	Target Corporation	24a0144d-cbfc-4d2f-873d-86adfa0468ca	2025-04-02	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
CareOne Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	American Sales Company	f8bfc874-53be-41e8-b59c-d538825761a8	2025-04-01	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
berkley and jensen sleep aid	DOXYLAMINE SUCCINATE	BJWC	25f468a9-71d4-40f2-97bb-1c3ff5d4b728	2025-03-31	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
topcare sleep aid	DOXYLAMINE SUCCINATE	Topco Associates LLC	c8b24ed8-34a1-4857-8fcb-6e3f9d407903	2025-03-26	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
good sense sleep aid ultra	DOXYLAMINE SUCCINATE	L. Perrigo Company	6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd	2025-03-06	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
dg health sleep aid	DOXYLAMINE SUCCINATE	Dolgencorp Inc	a4c6b400-7fa6-4ad1-9d39-d34621eb91a6	2025-03-05	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
TopCare Sleep Aid	DOXYLAMINE SUCCINATE	Topco Associates LLC	15dc89c4-b7ce-4d36-8107-f501daaf289b	2025-02-16	Warnings	Exact identifier application applno (ANDA): 040167 application number: ANDA040167
ultra sleep aid	DOXYLAMINE SUCCINATE	Walgreen Company	90a5986d-2555-4c2d-8e41-16537ff1aa36	2025-02-07	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1101446	doxylamine succinate 25 MG Oral Tablet	PSN	d0295e0b-aba8-4cc7-b83c-b494d552413b	2
1101446	doxylamine succinate 25 MG Oral Tablet	SCD	d0295e0b-aba8-4cc7-b83c-b494d552413b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76162-159-62	76162015962	24 BLISTER PACK in 1 CARTON (76162-159-62) / 1 TABLET in 1 BLISTER PACK	24 blister pack	2023-06-16	No	No	Current
76162-159-67	76162015967	48 BLISTER PACK in 1 CARTON (76162-159-67) / 1 TABLET in 1 BLISTER PACK	48 blister pack	2024-01-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Sleep Aid Drug Facts	Topco Associates LLC	2024-03-28	HUMAN OTC DRUG LABEL	2