FDA.reportPublic FDA data

Banophen

Manufacturer
Health Department, Oklahoma State
Effective date
2025-01-29
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:24:31

Label at a glance#

ProductBanophen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

OTC - WHEN USING SECTION

marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HClDiphenhydramine HCl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092421BANOPHEN 25 MG Oral TabletPSN1
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBD1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1
1092421Banophen 25 MG Oral TabletSY1

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
83112-555-59Banophen1 in 1 PACKETTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83112-555BANOPHEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HEALTH DEPARTMENT, OKLAHOMA STATE]1Current NDC, 1 package rows20250131_2cdbe7df-4c67-9b05-e063-6394a90a4699.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5551-24EA - Each0904-5551805dcd85-34b6-4a0a-9406-d46680925db812012-07-24
0904-5551-59EA - Each0904-55516037c229-d392-48f1-bbd8-febe968f67a312012-07-24

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83112-55583112-555-59
0904-5551

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c12025-10-27WarningsExact identifier
ndc (product): 0904-5551
BanophenDIPHENHYDRAMINE HCLHealth Department, Oklahoma State2cdbe7df-4c67-9b05-e063-6394a90a46992025-01-29Exact identifier
ndc (package): 83112-555-59
ndc (product): 83112-555
ndc11 (package): 83112055559
spl id: 2cdbe7df-4c68-9b05-e063-6394a90a4699
spl set id: 2cdbe7df-4c67-9b05-e063-6394a90a4699

Reported adverse events (FAERS/openFDA)#

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