Topcare ZZZ Sleep

Product NDC: 36800-200
11-digit product format: 368000200
Labeler code: 36800
Product ID: 36800-200_b2891495-9d6a-4173-bf1b-a94d7747370c
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Topco Associates LLC
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-08-20
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/30mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-200	36800-200-30	D	Discontinued by firm		2026-10-12
excluded package	package	36800-200	36800-200-34	D	Discontinued by firm		2026-10-12

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 · 22 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	36800-200-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-200-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-200-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-200-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-200-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-200-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-200-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-200-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-200-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-200-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-200-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-200-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-200-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-200-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-200-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-200-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-200-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-200-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-200-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-200-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-200-34	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-200-34	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Topcare ZZZ Sleep
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1248354	Internal RxNorm lookup
1437306	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
27225d04-6deb-436b-89ea-9842c487292e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-200-30	Topcare ZZZ Sleep	177 mL in 1 BOTTLE	SOLUTION	177	9
36800-200-34	Topcare ZZZ Sleep	236 mL in 1 BOTTLE	SOLUTION	236	9
36800-200-40	Topcare ZZZ Sleep	355 mL in 1 BOTTLE	SOLUTION	355	9
36800-200-50	Topcare ZZZ Sleep	355 mL in 1 BOTTLE	SOLUTION	355	9
36800-200-50	Topcare ZZZ Sleep	2 in 1 PACKAGE	SOLUTION	2	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-200	TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	8	Current NDC, Legacy NDC, 5 package rows	20241018_27225d04-6deb-436b-89ea-9842c487292e.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 8 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health sleep aid	DIPHENHYDRAMINE HCL	Dolgencorp, LLC	4c266acb-49ae-4d04-8602-0df35b22874a	2025-07-10	Warnings	Exact identifier application number: M010
NIGHT TIME SLEEP-AID	DIPHENHYDRAMINE HCL	Advanced Rx LLC	07c69e63-deb1-4607-9f7f-1cf0cd05cc82	2025-07-02	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	896ae7b8-cb8d-1aaa-e053-2a95a90a4e1a	2025-06-30	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	TOP CARE (Topco Associates LLC)	027d7eff-6c83-40f1-9716-231637cdbeba	2025-06-12	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid maximum strength	DIPHENHYDRAMINE HCL	Cardinal Health (Leader) 70000	546e4fda-6eb2-4358-840e-e2473bf7f352	2025-06-03	Warnings	Exact identifier application number: M010
Simply Sleep	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	2025-06-02	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	e9bc5a16-b1fc-4585-8f3b-30ccf4300492	2025-05-30	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (Retail Business Services, LLC.)	51e633a8-5bfc-4ff9-816f-3bc22b8a5c4c	2025-05-23	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	Care One (Retail Business Services, LLC.)	536cd7d6-a470-4614-89c8-6c3ada582a90	2025-05-23	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Cardinal Health (Leader) 70000	133d6f38-9de7-4104-8175-3933b263afe0	2025-05-16	Warnings	Exact identifier application number: M010
Nighttime Sleep-aid	DIPHENHYDRAMINE HCL	NORTHEAST PHARMA	d2062094-d1b5-38ab-e053-2995a90a5670	2025-05-15	Warnings	Exact identifier application number: M010
Nighttime Sleep-aid	DIPHENHYDRAMINE HCL	Geri-Care Pharmaceutical Corp	0fce381f-28ef-4591-a569-c5d599a3b95f	2025-05-14	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	54bdb6bc-622c-412a-8365-a1b1c968e13e	2025-05-01	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	217a211e-b8bf-4119-a094-0e5e733d0b18	2025-04-21	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	25f32a1c-0687-45e9-8142-96cf63599090	2025-04-03	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	FSA Store Inc. (Caring Mills)	9d32a3a1-9528-4de4-9fd1-1d01a1ad93e9	2025-03-28	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	WR Group, Inc.	d28d0f6d-8029-4e31-b417-4f8f864d840e	2025-03-28	Warnings	Exact identifier application number: M010
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	P & L Development, LLC	4144b1a6-aeae-4560-a997-b07206d80350	2025-03-24	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	a512413c-639b-4846-b016-332a78b50ab7	2025-03-21	Warnings	Exact identifier application number: M010
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	PD-Rx Pharmaceuticals, Inc.	1ee41c86-6767-43ca-a5bb-fc685fa662cd	2025-03-20	Warnings	Exact identifier application number: M010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1248354	diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution	PSN	27225d04-6deb-436b-89ea-9842c487292e	9
1437306	ZZZ Sleep 50 MG in 30 mL Oral Solution	PSN	27225d04-6deb-436b-89ea-9842c487292e	9
1437306	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution [ZZZ Sleep]	SBD	27225d04-6deb-436b-89ea-9842c487292e	9
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	27225d04-6deb-436b-89ea-9842c487292e	9
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	27225d04-6deb-436b-89ea-9842c487292e	9
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	27225d04-6deb-436b-89ea-9842c487292e	9
1437306	ZZZ Sleep 1.67 MG/ML Oral Solution	SY	27225d04-6deb-436b-89ea-9842c487292e	9
1437306	ZZZ Sleep 50 MG per 30 ML Oral Solution	SY	27225d04-6deb-436b-89ea-9842c487292e	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-200-30	36800020030	177 mL in 1 BOTTLE (36800-200-30)	177 ml	2013-08-23	0000-00-00	No	No	Current
36800-200-34	36800020034	236 mL in 1 BOTTLE (36800-200-34)	236 ml	2013-09-19	0000-00-00	No	No	Current
36800-200-40	36800020040	355 mL in 1 BOTTLE (36800-200-40)	355 ml	2013-08-20	0000-00-00	No	No	Current
36800-200-50	36800020050	2 BOTTLE in 1 PACKAGE (36800-200-50) / 355 mL in 1 BOTTLE	2 bottle	2013-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. ZZZ Sleep ® Drug Facts	Topco Associates LLC	2025-12-11	HUMAN OTC DRUG LABEL	9