FDA.reportPublic FDA data

Onral Oral Pain Reliever Mouthwash

Manufacturer
Syka Pharma Inc. | Delta Pharma Inc
Effective date
2025-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:06

Label at a glance#

ProductOnral Oral Pain Reliever Mouthwash
Active ingredientBENZOCAINE
Label structure7 sections

Indications and uses

For the temporary relief of minor irritation, pain, sore mouth, and sore throat.

Dosage and administration

Shake well upside down. Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out. Children under 12 years of age should be supervised in the use of the product. Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Do not use for teething. Children under 2 years of age: Do not use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor irritation, pain, sore mouth, and sore throat.

Warnings

WARNINGS SECTION

If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentists or doctor promptly.

  • Do not exceed recommended dosage.

Do not use

OTC - DO NOT USE SECTION

  • this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics.

Methemoglobinemia warning:

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before.

Stop use and seek immediate medical attention

OTC - STOP USE SECTION

if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • rapid heart rate
  • dizziness or lightheadedness
  • headache
  • shortness of breath
  • atigue or lack of energy

Keep out of reach of children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well upside down.
  • Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out.
  • Children under 12 years of age should be supervised in the use of the product.
  • Apply to the affected area.
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Do not use for teething.
  • Children under 2 years of age: Do not use.

Other information

SPL UNCLASSIFIED SECTION

store at 68-77 ° F (20-25 ° C)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Purified water, Vegetable glycerin, PEG 400, Sorbitol, Polysorbate 80, Natural orange flavor, Potassium sorbate, Xanthan gum, Citric acid, Beta-carotene.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2717653benzocaine 5 % MouthwashPSN1
2717653benzocaine 50 MG/ML MouthwashSCD1
2717653benzocaine 5 % MouthwashSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85454-0421-1Onral Oral Pain Reliever Mouthwash1 in 1 CARTONLIQUID11
85454-0421-1Onral Oral Pain Reliever Mouthwash230 mL in 1 BOTTLE, PLASTICLIQUID2301

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85454-042185454-0421-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBITOL506T60A25RIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BETA CAROTENE01YAE03M7JIACT
BENZOCAINEU3RSY48JW5ACTIB

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
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
ndc (package): 85454-0421-1
ndc (product): 85454-0421
ndc11 (package): 85454042101
spl id: 36b1704e-640d-bab5-e063-6394a90a4145
spl set id: 5dd8d933-6f32-4eaf-8eca-9365d7de55a2

Reported adverse events (FAERS/openFDA)#

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