nitetime sleep aid

Product NDC: 41250-044
11-digit product format: 412500044
Labeler code: 41250
Product ID: 41250-044_c4a06b7d-0b3a-4365-95dc-cde224cb37ca
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Meijer Distribution Inc
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-04
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	41250-044	41250-044-30	D	Discontinued by firm		2026-10-05
excluded package	package	41250-044	41250-044-50	D	Discontinued by firm		2026-10-05

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	41250-044-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41250-044-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-044-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-044-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-044-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-044-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-044-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-044-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-044-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-044-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-044-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-044-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-044-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-044-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-044-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-044-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-044-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-044-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-044-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-044-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-044-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41250-044-30	`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: nitetime sleep aid
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1248354	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
43184abd-2525-402a-a388-85af2e5c13ad	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
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
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
41250-044-30	nitetime sleep aid	177 mL in 1 BOTTLE	SOLUTION	177	8
41250-044-40	nitetime sleep aid	355 mL in 1 BOTTLE	SOLUTION	355	8
41250-044-50	nitetime sleep aid	2 in 1 CARTON	SOLUTION	2	8
41250-044-50	nitetime sleep aid	355 mL in 1 BOTTLE	SOLUTION	355	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-044	NITETIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	8	Current NDC, Legacy NDC, 4 package rows	20241019_43184abd-2525-402a-a388-85af2e5c13ad.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 12 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Night Time Sleep Aid	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	6d34ee3e-3d61-481e-98d6-acfa066e4247	2024-10-16	Warnings	Exact identifier application number: M010
basic care nighttime sleep aid	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	027de5ea-5c07-4960-8a98-8cf2c0e54a92	2024-10-16	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	H E B	d5189048-5eed-4ec4-8c4a-4a167728c4e7	2024-10-16	Warnings	Exact identifier application number: M010
berkley and jensen sleep aid	DIPHENHYDRAMINE HCL	BJWC	e31917a1-e72d-4f71-893f-43046169a32d	2024-10-16	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	5fab9bd4-66d7-4356-a778-8900b2e270e2	2024-10-11	Warnings	Exact identifier application number: M010
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5b005bfc-f588-4abc-8bb1-4691b40448cd	2024-10-07	Warnings	Exact identifier application number: M010
Sominex	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	f70ce1a6-c334-025e-e053-6294a90ae53f	2024-10-03	Warnings	Exact identifier application number: M010
meijer NIGHTTIME Sleep Aid CAPLET	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1c2b57b3-92cb-256b-e063-6394a90ad41b	2024-09-09	Warnings	Exact identifier application number: M010
Up and Up Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	0ab5a374-d565-4385-bee3-538a8f09b19e	2024-08-15	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	8d985ad7-71b9-493f-9b9a-d6ef280f72dd	2024-08-12	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	3618eb73-6929-4ca5-833d-265b006f15f9	2024-08-12	Warnings	Exact identifier application number: M010
careone nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	14803f99-52c7-4324-b64c-971906144739	2024-07-17	Warnings	Exact identifier application number: M010
Betr sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	Live Betr LLC	8c2d5514-62c1-4e98-8412-20534365b934	2024-07-17	Warnings	Exact identifier application number: M010
topcare sleep aid nighttime	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	30284271-0411-4abf-bc62-d956dc794432	2024-07-17	Warnings	Exact identifier application number: M010
dg health sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp Inc	038c1b4e-43f5-4370-896b-97da1b0a89ca	2024-07-17	Warnings	Exact identifier application number: M010
good sense nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	ba2adc30-0301-4d53-bce6-fc8b7e34b076	2024-07-10	Warnings	Exact identifier application number: M010
Sleep Aid	SLEEP AID	Good Sense	c1481fad-9b32-4f84-8f03-4b4fa5edc866	2024-06-18	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	29b49616-ee5a-4574-81f1-0052addb8f66	2024-04-22	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	b8757d18-6c7d-45de-925a-e2814625f749	2024-04-22	Warnings	Exact identifier application number: M010
EZ Nite Sleep	DIPHENHYRAMINE HYDROCHLORIDE	KROGER COMPANY	0fec16a4-b4eb-8f8f-e063-6394a90a7327	2024-04-17	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	43184abd-2525-402a-a388-85af2e5c13ad	8
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	43184abd-2525-402a-a388-85af2e5c13ad	8
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	43184abd-2525-402a-a388-85af2e5c13ad	8
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	43184abd-2525-402a-a388-85af2e5c13ad	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-044-30	41250004430	177 mL in 1 BOTTLE (41250-044-30)	177 ml	2015-04-15	0000-00-00	No	No	Current
41250-044-40	41250004440	355 mL in 1 BOTTLE (41250-044-40)	355 ml	2014-12-04	0000-00-00	No	No	Current
41250-044-50	41250004450	2 BOTTLE in 1 CARTON (41250-044-50) > 355 mL in 1 BOTTLE	2 bottle	2018-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Nighttime Sleep-Aid Drug Facts	Meijer Distribution Inc	2024-10-17	HUMAN OTC DRUG LABEL	8