Sleep Aid

Product NDC: 67091-413
11-digit product format: 670910413
Labeler code: 67091
Product ID: 67091-413_777f6808-7458-4650-9953-ec52451a2b75
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: WinCo Foods, LLC
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-29
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Sleep Aid
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020477	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
e9bc5a16-b1fc-4585-8f3b-30ccf4300492	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
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	Strength	SPL version
67091-413-32	Sleep AidMaximum Strength	32 in 1 BOTTLE, PLASTIC	CAPSULE	32		4
67091-413-32	Sleep AidMaximum Strength	1 in 1 BOX	CAPSULE	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-413	SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241122_e9bc5a16-b1fc-4585-8f3b-30ccf4300492.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 9 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 67091-413
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
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	BI-MART	2914504a-ed42-4168-9e5c-f49407ed5a30	2025-05-20	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
Diphenhydramine HCl Maximum Strength	DIPHENHYDRAMINE HCL	Bi-Mart	b89c80aa-27ae-4fce-b574-8ee64bbae275	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
Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AID	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	The Procter & Gamble Manufacturing Company	32bedbbc-b939-1bea-e063-6394a90a6934	2025-04-14	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
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	e9bc5a16-b1fc-4585-8f3b-30ccf4300492	4
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	e9bc5a16-b1fc-4585-8f3b-30ccf4300492	4
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	e9bc5a16-b1fc-4585-8f3b-30ccf4300492	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67091-413-32	67091041332	1 BOTTLE, PLASTIC in 1 BOX (67091-413-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC	2022-04-29	0000-00-00	No	No	Current