Diphenhydramine Hydrochloride

Product NDC: 82501-1578
11-digit product format: 825011578
Labeler code: 82501
Product ID: 82501-1578_ee17d291-2a44-3ba7-e053-2a95a90a4ffb
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Gobrands, Inc
Application: part338
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-05-16
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
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	82501-1578		I	Inactivated by FDA		2026-10-05
excluded package	package	82501-1578	82501-1578-2	I	Inactivated by FDA		2026-10-05

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82501-1578-2	Diphenhydramine Hydrochloride	24 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	24		5
82501-1578-2	Diphenhydramine Hydrochloride	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82501-1578	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [GOBRANDS, INC]	5	Legacy NDC, 2 package rows	20241222_11b7c200-b79f-4e35-9d53-00f021fa43b0.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	11b7c200-b79f-4e35-9d53-00f021fa43b0	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	11b7c200-b79f-4e35-9d53-00f021fa43b0	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82501-1578-2	82501157802	1 BLISTER PACK in 1 CARTON (82501-1578-2) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2022-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIGHTTIME Sleep Aid Diphenhydramine HCl	Gobrands, Inc \| Prodose, Inc	2024-12-20	HUMAN OTC DRUG LABEL	5