FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Contract Pharmacal Corp.
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:07

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prestige labelPrestige label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1085945diphenhydrAMINE HCl 50 MG Oral TabletPSN2
1085945diphenhydramine hydrochloride 50 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10267-5344-9Diphenhydramine Hydrochloride16 in 1 BOTTLETABLET, FILM COATED162
10267-5344-9Diphenhydramine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10267-5344DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACAL CORP.]22 package rows20231202_82fc326a-99bb-9a08-e053-2991aa0a53c2.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10267-534410267-5344-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSES3NXW29V3WOIACT
TALC7SEV7J4R1UIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b75c508-0657-9bcb-e063-6394a90a006e82fc326a-99bb-9a08-e053-2991aa0a53c22023-12-01Exact identifier
spl id: 0b75c508-0657-9bcb-e063-6394a90a006e
spl set id: 82fc326a-99bb-9a08-e053-2991aa0a53c2

Reported adverse events (FAERS/openFDA)#

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