Onral Oral Pain Reliever Mouthwash

Benzocaine · Liquid · Oral

Over the counter Standardized Chemical Allergen

Active ingredient

Active ingredient Benzocaine 5% Purpose Oral Pain Reliever

Purpose

Purpose Oral Pain Reliever

Uses

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

Warnings

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

Do not use

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics.

Stop use and ask a doctor

Stop use and seek immediate medical attention 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

Keep out of reach of children

Directions

Directions 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.

Inactive ingredients

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

Label text from the FDA structured product label by Syka Pharma Inc. (revised Jun 3, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Onral Oral Pain Reliever Mouthwash NDC products (1)

NDCStrength & formLabelerType
85454-0421Benzocaine 50 mg/mL
Liquid
Syka Pharma Inc.OTC MONOGRAPH DRUG

Frequently asked questions

What is Onral Oral Pain Reliever Mouthwash used for?

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

Who makes Onral Oral Pain Reliever Mouthwash?

Onral Oral Pain Reliever Mouthwash is listed by 1 labeler in the FDA NDC directory, including Syka Pharma Inc..