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 7 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	AMERISOURCE BERGEN	16b2edd2-c16b-5713-e063-6394a90acf46	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	VALU MERCHANDISERS COMPANY	08a38cd2-04ae-1ef9-e063-6294a90a8868	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	KROGER COMPANY	0f2c1c6a-29bc-e4a8-e063-6394a90a28cb	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	35acf7d9-e567-996d-e063-6394a90a1cf6	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	048cfa3a-4519-400d-a5ab-ce05c9cc4ec8	2025-11-26	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fe58ce40-ae88-4dc5-9486-e67041f6d852	2025-11-26	Warnings	Exact identifier application number: M010
nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	b72c47a3-cae3-4b98-ae85-e1313b6fd501	2025-11-25	Warnings	Exact identifier application number: M010
Nighttime Wal Flu Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	WALGREEN CO.	e88f7777-9987-4e3c-a3d5-3da60f190bfd	2025-11-25	Warnings	Exact identifier application number: M010
Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALGREENS CO	807e8ace-2901-4c5f-96dc-04c755484b95	2025-11-25	Warnings	Exact identifier application number: M010
Sleep	DIPHENHYDRAMINE HCL	Salado Sales, Inc.	837c02dd-971b-4451-98d8-9c438c9db696	2025-11-24	Warnings	Exact identifier application number: M010
Nighttime SleepAid	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	3802d57e-7943-c0c2-e063-6394a90a7580	2025-11-20	Warnings	Exact identifier application number: M010
Sleep-Aid Nighttime	DIPHENHYDRAMINE HCL	CVS PHARMACY	6bd1ad2e-8f47-412d-8620-b149ad90c292	2025-11-17	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	f8d50b4e-735d-4d91-a18d-be3537e46e99	2025-11-15	Warnings	Exact identifier application number: M010
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Company name: Topco Associates, LLC	7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec	2025-10-31	Warnings	Exact identifier application number: M010
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	e96ec4d4-53b9-4636-a58c-1a5923a021ad	2025-10-31	Warnings	Exact identifier application number: M010
GOODNOW SLEEP AID	DIPHENHYDRAMINE HCL	Gobrands, Inc	7d821b7d-6a31-4ff7-b587-51907ba62658	2025-10-29	Warnings	Exact identifier application number: M010
Meijer Nighttime Sleep-aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	c7258241-2966-4876-918b-84bbf50ec4bc	2025-10-24	Warnings	Exact identifier application number: M010
Meijer Nighttime Sleep Aid Non Habit Forming	DIPHENHYDRAMINE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	fd476bfa-3e2e-470c-9180-19aa43e4af24	2025-10-24	Warnings	Exact identifier application number: M010
Sominex	DIPHENHYDRAMINE HYDROCHLORIDE	Medtech Products Inc.	f7858ecf-8498-4465-85d8-3e7814737573	2025-10-23	Warnings	Exact identifier application number: M010
Sominex Max	DIPHENHYDRAMINE HCL	Medtech Products Inc.	e8f6991f-c47a-4d12-934b-04fdf092dac3	2025-10-23	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