CankerMelts

The listing

NDC product code

68229-700 (labeller 68229, product 700)

Labeller

Quest Products, LLC

Brand name

CankerMelts

Generic name

benzocaine

Dosage form

Lozenge

Route

oral

Marketing category

OTC MONOGRAPH DRUG M022

Marketing start

6 October 2023

Listing expires

31 December 2026

Pharmacologic class

Standardized Chemical Allergen [EPC]

RxNorm concept

199071

Active ingredients

Strengths as listed in the FDA National Drug Code Directory, retrieved 4 September 2026. "Other listings" counts every other product on this site containing the same ingredient at any strength.

What the label claims

These are read from this product's own label, not assigned by us and not inferred from the ingredient.

Stated useSore mouth, gums and canker sores

Drug Facts, as filed

Quoted from the label FDA holds for this product. Long fields are truncated. The panel printed on the package you are holding is the one that governs.

Active ingredient

(in each self-adhering tablet) Benzocaine 15mg

Purpose

Oral Pain Relief

Uses

for temporary relief of pain associated with: canker sores minor irritation mouth sores

Warnings

Methemoglobinemea warning: Use of this product may cause methemoglobinemea, a serious- condition that must be treated promptly because it reduces 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) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. Do not use: this product for more than 7 days unless directed by a doctor or dentist in children under 5 years of age When using this product do not exceed recommended dosage. Stop use and ask a doctor or dentist if: if sore mouth symptoms do not improve in 7 days if irritation, pain, or redness persists or worsens if swelling, rash or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children in case of overdose, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

Stop use and ask a doctor or dentist if: if sore mouth symptoms do not improve in 7 days if irritation, pain, or redness persists or worsens if swelling, rash or fever develops

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

Directions

Adults and children age 5 and older: Affix one tablet as directed below and allow to slowly dissolve in the mouth. May be repeated every 2 hours as needed or directed by a doctor or dentist. This product may last over 2 hours. Placement: CankerMelts are bi-layered tablets with a dimple on the adhesive side and a pain reliever on the domed side marked CM. Place the adhesive side with a dimple against teeth or gums or braces or appliance. Place opposite or adjacent to the sore. Hold tablet in place with your cheek or tongue for 10 seconds to initiate adhesion. Adhesion will strengthen over the next few minutes. It may be removed at any time. Children under 5 years of age: Do not use.

Inactive ingredients

Acacia gum, cellulose gum, hyaluronic acid, magnesium stearate, maize dextrin, methylcobalamin (vitamin B12), mint oil, sodium bicarbonate, xylitol

Label version 5, effective 4 December 2025. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.

Packages

The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.

Identical on the active ingredient

3 other listings state exactly the same active ingredient at exactly the same strength in the same dosage form, across 2 different labellers. They are not necessarily the same product: inactive ingredients, flavour and pack size differ, and this site does not compare prices.

Sources for this page

• FDA National Drug Code Directory entry for 68229-700
• DailyMed label, set id 070dae82-14c2-66d2-e063-6394a90ab259
• How Lozenges builds these pages