Sleep Aid

Product NDC: 82501-3141
11-digit product format: 825013141
Labeler code: 82501
Product ID: 82501-3141_33f81df6-a097-4429-a414-1c5f138fb412
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: LIQUID
Route: ORAL
Labeler: Gobrands, Inc. (Goodnow)
Application: part338
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-04-15
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 product	product	82501-3141		D	Discontinued by firm		2026-10-16
excluded package	package	82501-3141	82501-3141-2	D	Discontinued by firm		2026-10-16

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82501-3141	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) LIQUID [GOBRANDS, INC. (GOODNOW)]	2	Legacy NDC	20240404_fd57107e-7cb5-4fb7-abb9-09ac0c0ab0b8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82501-3141-2	82501314102	355 mL in 1 BOTTLE, PLASTIC (82501-3141-2)	355 ml	2022-04-15	0000-00-00	No	No	Current