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: 2026-12-31
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: 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
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 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLT 2	LIDOCAINE HCL	CENTURA PHARMACEUTICALS INC	41dc85ec-d79b-0a32-e054-00144ff8d46c	2026-01-12	Warnings	Exact identifier application number: M017
Mineral Ice Pain Relieving	MENTHOL	Crown Laboratories	7b30076a-0af6-2f74-e053-2a91aa0ae08d	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE	Crown Laboratories	19b0ce1b-e147-01a1-e063-6394a90af808	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE, MENTHOL	Crown Laboratories, Inc	19c41e75-a654-90cf-e063-6394a90a7e97	2026-01-12	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	HY-VEE, INC	48350b54-8d9a-48c4-e063-6394a90ac040	2026-01-12	Warnings	Exact identifier application number: M017
LidoPlus Pain Relief	LIDOCAINE HYDROCHLORIDE	Centura Pharmaceuticals, Inc	07bacc6c-60a6-4297-8663-904a22bdc040	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f1efb51c-5217-4cb2-e053-2a95a90a7f95	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f2277e27-868b-57ef-e053-2a95a90abf28	2026-01-12	Warnings	Exact identifier application number: M017
BLT 3	TETRACAINE	CENTURA PHARMACEUTICALS INC	401a0d22-1181-02ac-e054-00144ff88e88	2026-01-12	Warnings	Exact identifier application number: M017
Sting Relief Prep Pad	BENZOCAINE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	0c901f64-6890-45c0-9ca7-ee9de87903c4	2026-01-12	Warnings	Exact identifier application number: M017
Goodsense Oral Pain Relief	BENZOCAINE	Geiss, Destin and Dunn, Inc.	eb461b70-d10f-4e11-8374-e43713f3504d	2026-01-12	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM AND MENTHOL	Saje Natural Business Inc	f516e416-446b-8f21-e053-2a95a90afd88	2026-01-12	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	3df0e56a-7651-42dc-8ed8-f68836a63c61	2026-01-12	Warnings	Exact identifier application number: M017
Trauma Less	MENTHOL	Saje Natural Business Inc.	650cba4c-6aba-48c3-9c41-841f19905548	2026-01-12	Warnings	Exact identifier application number: M017
Mamisan	LIDOCAINE HYDROCHLORIDE, MENTHOL	Miramar Cosmetics, Inc DBA Miramar Lab	4402e900-c6e9-4f32-8cc4-c84014384a9f	2026-01-12	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch	LIDOCAINE 4% PATCH	Little Pharma, Inc.	1a8fe44e-7a21-c2ab-e063-6394a90a6100	2026-01-11	Warnings	Exact identifier application number: M017
DG Health Pain Relieving	LIDOCAINE HCL	DOLGENCORP, LLC	923aeb4c-049f-4ecc-a77e-9ffa0e236d4e	2026-01-11	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare	46b84e0b-78a9-4cde-9f90-e165b5419162	2026-01-09	Warnings	Exact identifier application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On	MENTHOL	Inspec Solutions	12ff9b9a-73e5-ce31-e063-6294a90aeaf8	2026-01-09	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bb0278c9-eaff-d435-e053-2995a90a202a	2026-01-09	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