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 106 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Green Compass Reduce Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	0a0b688e-50f1-3eb1-e063-6394a90a7efa	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Topical Pain	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	8cb80362-5d24-1ee3-e053-2a95a90afcdf	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Roll-On Pain Relief	MENTHOL	Green Compass, Inc.	b5916aa2-428c-5637-e053-2995a90a08b0	2025-01-01	Warnings	Exact identifier application number: M017
OKeeffes Working Hands Pain Relief Skin Protectant	ALLANTOIN, LIDOCAINE HYDROCHLORIDE	The Gorilla Glue Company/O'Keeffe's Company	0685da25-c9fa-e1cd-e063-6394a90ae1b3	2025-01-01	Warnings	Exact identifier application number: M017
Icy Hot with Lidocaine Pain Relieving	LIDOCAINE HCL AND MENTHOL	Chattem, Inc.	75b28b06-77ea-4fea-b516-2e8a0dac7037	2025-01-01	Warnings	Exact identifier application number: M017
Advanced Seal Barrier plus Pain Relief	LIDOCAINE	Kericure Inc.	7ac95325-e6e9-4c56-9315-876c00af7c98	2025-01-01	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Fragrance-Free	HYDROCORTISONE	Lovely Skin, Inc.	c12af4c6-2f05-46ec-b901-1a4fcd750180	2024-12-31	Warnings	Exact identifier application number: M017
Pain Relieving Cream Lidocaine	BENZYL ALCOHOL, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	039a2036-54b2-cf28-e063-6294a90a8ce6	2024-12-31	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief Walgreens	MENTHOL 10.5%	WALGREEN COMPANY	f1daa68d-1b12-c28a-e053-2995a90a0949	2024-12-31	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Advanced Rx of Tennessee, LLC	0b7736df-c7e0-7d00-e063-6294a90aa57e	2024-12-31	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Advanced Rx Pharmacy of Tennessee, LLC	f4bfc4a6-06ef-1f76-e053-2995a90a2b8f	2024-12-31	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream	LIDOCAINE, MENTHOL	Sato Pharmaceutical Co., Ltd.	2251e96b-d050-4ec2-a6b9-6659610885bf	2024-12-30	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Safeway	af2e2ef3-0f3f-4592-8081-b6553ade2f5a	2024-12-26	Warnings	Exact identifier application number: M017
Comforte Menstrual Cramp Relief Cream	MENTHOL	PMS4PMS LLC	c121537e-3333-4f35-8c77-20086158dff4	2024-12-26	Warnings	Exact identifier application number: M017
N-Labs Arcticzen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	NUTRIOMO LABS PTE. LTD	05ee574a-854c-4a77-be77-082055075c4d	2024-12-26	Warnings	Exact identifier application number: M017
BiteMD External Analgesic First Aid Antiseptic	BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL	United Industries Corporation	4c60db03-6d2b-4ae0-a200-718b3a50eb0f	2024-12-23	Warnings	Exact identifier application number: M017
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier application number: M017
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier application number: M017
FOOT WORKS MAXIMUM CRACKED HEEL	BENZALKONIUM CHLORIDE, LIDOCAINE	COSMAX USA, CORPORATION	29f92230-d1d4-5e94-e063-6294a90af812	2024-12-23	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