Nighttime Sleep-Aid

Product NDC: 76281-522
11-digit product format: 762810522
Labeler code: 76281
Product ID: 76281-522_f1654da1-64f7-4c2b-9201-3a7af430ba37
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCI
Dosage form: LIQUID
Route: ORAL
Labeler: AptaPharma Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-01-01
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: 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: Nighttime Sleep-Aid
Brand name suffix: Non-Habit Forming
Listing expiration: 2027-12-31

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
ed0ba7aa-e794-43da-b576-6b9945bf7477	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	SPL version
76281-522-24	Nighttime Sleep-AidNon-Habit Forming	118 mL in 1 BOTTLE	LIQUID	118	3
76281-522-25	Nighttime Sleep-AidNon-Habit Forming	177 mL in 1 BOTTLE	LIQUID	177	3
76281-522-28	Nighttime Sleep-AidNon-Habit Forming	354 mL in 1 BOTTLE	LIQUID	354	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76281-522	NIGHTTIME SLEEP-AID NON-HABIT FORMING (DIPHENHYDRAMINE HCI) LIQUID [APTAPHARMA INC.]	3	Current NDC, Legacy NDC, 3 package rows	20231231_ed0ba7aa-e794-43da-b576-6b9945bf7477.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 121 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Restorative Skin Therapy Itch Relief Balm	PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	61824ca7-a2d3-4830-b2bb-149a3222bfc8	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Exact identifier application number: M017
STING MASTER	LIDOCAINE HYDROCHLORIDE	Les Technologies Ptero, Inc	94c6fd1f-9e74-420b-9d25-61b37953b838	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35ac19-6883-a733-e063-6294a90ad22d	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	cfe8114b-df65-064b-e053-2a95a90a33f6	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Botanicals	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	02a8e5c7-56f4-eb0d-e063-6294a90a80cd	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn Pads	LIDOCAINE HYDROCHLORIDE	Quest Products, Inc.	fe58bb89-7216-4121-afd3-d1438bdfbfa2	2024-11-05	Warnings	Exact identifier application number: M017
Licefreee AfterLice	PRAMOXINE HCI	Tec Laboratories Inc.	06c4cc42-a215-3949-e063-6394a90a665e	2024-11-05	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	ASO LLC	cb9505b7-222d-3a24-e053-2a95a90a0b64	2024-11-05	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE	Topco Associates LLC	6b4783e0-1987-4838-9e8c-b95426d62b28	2024-11-05	Warnings	Exact identifier application number: M017
Eagle Green Balm	CAMPHOR MENTHOL	Borden Company (Private) Limited	6f7a796b-a31c-0e60-e053-2a91aa0a022b	2024-11-04	Warnings	Exact identifier application number: M017
Muscular Balm	CAPSAICIN MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	ed79f14e-6b3d-4bf2-9c34-d019c1ba2582	2024-11-04	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	A-S Medication Solutions	3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3	2024-11-04	Warnings	Exact identifier application number: M017
Walgreens Ice Blue Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Walgreen Company	1c0ee442-ffd2-4f6c-aab2-f70e295378ad	2024-11-04	Warnings	Exact identifier application number: M017
Walgreen Cool n Heat Maximum Strength Pain Relieving	MENTHOL, UNSPECIFIED FORM	Walgreen Company	d5c79476-dde8-4a85-8878-bc2ac3a3d70b	2024-11-04	Warnings	Exact identifier application number: M017
LIDOCAINE	LIDOCAINE	STRATUS PHARMACEUTICALS INC	87a4f559-a4f6-4b9f-98de-b55b073a11c6	2024-11-01	Warnings	Exact identifier application number: M017
Walgreens Nerve Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM	Walgreen Company	83849eca-e02f-4b43-b3a7-b25e987e08a8	2024-10-31	Warnings	Exact identifier application number: M017
Sanar Naturals Arnica White	CAMPHOR	Sanvall Enterprises, Inc	192039a2-aed6-821b-e063-6394a90a7f29	2024-10-31	Warnings	Exact identifier application number: M017

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	ed0ba7aa-e794-43da-b576-6b9945bf7477	3
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	ed0ba7aa-e794-43da-b576-6b9945bf7477	3
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	ed0ba7aa-e794-43da-b576-6b9945bf7477	3
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	ed0ba7aa-e794-43da-b576-6b9945bf7477	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76281-522-24	76281052224	118 mL in 1 BOTTLE (76281-522-24)	118 ml	2018-01-01	0000-00-00	No	No	Current
76281-522-25	76281052225	177 mL in 1 BOTTLE (76281-522-25)	177 ml	2018-01-01	0000-00-00	No	No	Current
76281-522-28	76281052228	354 mL in 1 BOTTLE (76281-522-28)	354 ml	2018-01-01	0000-00-00	No	No	Current