FDA.reportPublic FDA data

Banophen - Bryant Ranch Prepack

Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-24
Label type
HUMAN OTC DRUG LABEL
Version
106
Source
full-release
Hydrated at
2026-06-01 01:55:10

Label at a glance#

ProductBanophen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Take every 4-6 hours Do not take more than 6 doses in 24 hours adults and children 12 years of age and over Take 1 capsule (50 mg) children under 12 years of age ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Label contents#

Full prescribing information#

Active Ingredient (in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing

WARNINGS SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours
adults and children 12 years of age and overTake 1 capsule (50 mg)
children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

SPL UNCLASSIFIED SECTION

  • Store in a dry place at 15° – 30°C (59° – 86°F).
  • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

OTC - QUESTIONS SECTION

Questions or comments?1-800-231-4670

HOW SUPPLIED

How Supplied Section

BANOPHEN

Diphenhydramine Hydrochloride 50mg Capsules

  • NDC 63629-9451-1: 30 CAPSULEs in a BOTTLE
  • NDC 63629-9451-2: 60 CAPSULEs in a BOTTLE

Store in a dry place at 15° – 30°C (59° – 86°F).

Do not use if either capsule band or imprinted safety seal under cap is broken or missing.

Protect from moisture. Contains lactose.

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANOPHEN

Diphenhydramine Hydrochloride 50mg Capsules

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020479BANOPHEN 50 MG Oral CapsulePSN106
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN106
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBD106
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD106
1020479Banophen 50 MG Oral CapsuleSY106
1020477diphenhydramine HCl 50 MG Oral CapsuleSY106

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00363629945115(21)0123456789(17)280422(10)208820GTIN-14: 00363629945115
GTIN-12: 363629945115
UPC-A: 363629945115
EAN-13: 0363629945115
GTIN storage (14 digits): 00363629945115		lbl636299451.jpg
Data codeCode 1286362994511lbl636299451.jpg

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
63629-9451-1Banophen30 in 1 BOTTLECAPSULE30106
63629-9451-2Banophen60 in 1 BOTTLECAPSULE60106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5307-60EA - Each0904-5307fbc100c3-1d2e-4360-bd2f-a92b1e556d3b12013-02-11
0904-5307-80EA - Each0904-5307602b6862-e0e7-4d9b-bcb4-48a7a3eba31612013-02-11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63629-945163629-9451-1, 63629-9451-2
0904-5307

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, CORNO8232NY3SJIACT
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
b5c0472c-8488-4a09-8319-ccebdf4a77afd0f4b9f4-e727-4d47-b156-7bcdcb1606da2026-04-24WarningsExact identifier
spl id: b5c0472c-8488-4a09-8319-ccebdf4a77af
spl set id: d0f4b9f4-e727-4d47-b156-7bcdcb1606da
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
ndc (product): 0904-5307

Reported adverse events (FAERS/openFDA)#

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