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		2026-08-17
excluded package	package	41250-044	41250-044-50	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 · 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…`

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 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
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