Simply Sleep

Product NDC: 50580-843
11-digit product format: 505800843
Labeler code: 50580
Product ID: 50580-843_369b679c-4911-8ef8-e063-6394a90abd0a
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-02-01
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50580-843	50580-843-11	D	Discontinued by firm		2026-08-17

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup
1092466	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
37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50580-843-11	2024-02-01	Simply Sleep
50580-843-12	2024-02-01	Simply Sleep
50580-843-11	2024-01-30	Simply Sleep
50580-843-12	2024-01-30	Simply Sleep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-843-11	Simply Sleep	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	11
50580-843-11	Simply Sleep	2 in 1 CARTON	TABLET, FILM COATED	2	11
50580-843-12	Simply Sleep	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
50580-843-12	Simply Sleep	1 in 1 CARTON	TABLET, FILM COATED	1	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-843-12	EA - Each	50580-843	d51b8f92-9e03-4b6b-98d1-9abc4eea6c8c	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
diphenhydramine	ACTIVE MOIETY	8GTS82S83M	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-843	SIMPLY SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]	10	Current NDC, Legacy NDC, 4 package rows	20241109_37c606b0-04d5-49f0-886a-3ee2c9b0e9cc.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 14 · 262 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	CVS PHARMACY	333e170e-52cd-4218-8d15-0bf3c5c75cb9	2026-08-14	Warnings	Exact identifier application number: M010
CVS NightTime Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	0f0cc40d-7939-4d4d-a931-b4de4070fea1	2026-08-14	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	8db277e2-9d98-40b6-8000-a51c57fb4ece	2026-08-14	Warnings	Exact identifier application number: M010
Theraflu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CVS PHARMACY	4b567234-1da9-4e10-a427-877eea2be1c1	2026-08-14	Warnings	Exact identifier application number: M010
CVS Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY	87d4cfc0-c7b4-42c0-bfa9-96e124e32ed3	2026-08-14	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	6fb6cfde-30a6-419c-973d-8abdc72611ed	2026-08-07	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	2bb3016a-2e03-43fe-a655-45d4ec872c79	2026-08-05	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Alcohol Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	6e398d21-6cfa-4f9b-9219-0cd949e88266	2026-08-05	Warnings	Exact identifier application number: M010
Sleep Tabs	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	ff8b7346-5be5-4e76-9ee2-d52fab66f6c5	2026-08-03	Warnings	Exact identifier application number: M010
Mantra	MANTRA SLEEP AID WILD CHERRY	MOREMED INC.	316d11fe-a173-a1dd-e063-6394a90af499	2026-07-27	Warnings	Exact identifier application number: M010
Wal Som Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreens	ff475a69-dbb2-40a9-b7f4-9c7b7e975d19	2026-07-23	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	TARGET Corporation	336ac29d-db24-44da-a299-5a4793ae8f6a	2026-07-21	Warnings	Exact identifier application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	9bf2d698-8394-46c3-b7a9-e99ab6bb88e4	2026-07-17	Warnings	Exact identifier application number: M010
ADWE dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	ea3a51af-3025-497f-8cd7-e99391b0d06f	2026-07-17	Warnings	Exact identifier application number: M010
nighttime sleep aid	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	a8056e5f-e9d8-4555-9212-bf1fa3c15439	2026-07-16	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Amerisource Bergen	147adc14-ca7c-45f5-9925-ea569edbfe96	2026-07-09	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Health Pharma USA LLC	d659f747-9790-8bd6-e053-2995a90ae793	2026-07-07	Warnings	Exact identifier application number: M010
Pharbedryl	DIPHENHYDRAMINE HCL	St. Mary's Medical Park Pharmacy	3ef18965-bafb-cc19-e063-6394a90af17d	2026-06-29	Warnings	Exact identifier application number: M010
CalmCo Sleep Aid	DIPHENHYDRAMINE HCL	CalmCo LLC	552d0e50-a58c-8e47-e063-6394a90a8f7b	2026-06-26	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Night Pain	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	a7cf8e2e-7aac-a1fa-e053-2a95a90a561a	2026-06-26	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
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	11
1092466	Simply Sleep 25 MG Oral Tablet	PSN	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	11
1092466	diphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]	SBD	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	11
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	11
1092466	Simply Sleep 25 MG Oral Tablet	SY	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-843-11	50580084311	12 in 1 BLISTER PACK						Historical
50580-843-12	50580084312	1 BOTTLE in 1 CARTON (50580-843-12) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2013-04-10	0000-00-00	No	No	Current