Diphenhydramine Hydrochloride

Manufacturer: Contract Pharmacal Corp.
Effective date: 2023-11-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:03:01

Label at a glance#

ProductDiphenhydramine Hydrochloride

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prestige label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	2
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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	Strength	SPL version
10267-4658-6	Diphenhydramine Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10		2
10267-4658-6	Diphenhydramine Hydrochloride	2 in 1 CARTON	TABLET, FILM COATED	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10267-4658	DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACAL CORP.]	2	2 package rows	20231201_82e7ebfc-8e46-6163-e053-2991aa0a68c9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

Diphenhydramine Hydrochloride
DIPHENHYDRAMINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
CROSCARMELLOSE SODIUM
CROSCARMELLOSE
LIGHT MINERAL OIL
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10267-4658	10267-4658-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0b6491e8-cd64-55e1-e063-6394a90a9b0d			82e7ebfc-8e46-6163-e053-2991aa0a68c9	2023-11-30		Exact identifier spl id: 0b6491e8-cd64-55e1-e063-6394a90a9b0d spl set id: 82e7ebfc-8e46-6163-e053-2991aa0a68c9

Reported adverse events (FAERS/openFDA)#

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