FDA.reportPublic FDA data

CankerMelts

Manufacturer
Quest Products, LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:11

Label at a glance#

ProductCankerMelts
Active ingredientBENZOCAINE
Label structure8 sections

Indications and uses

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

Dosage and administration

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. 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 adjace...

Label contents#

Full prescribing information#

Active Ingredient (in each self-adhering tablet)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 15mg

Purpose

OTC - PURPOSE SECTION

Oral Pain Relief

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain associated with:

  • canker sores
  • minor irritation
  • mouth sores

Warnings

WARNINGS SECTION

Methemoglobinemea warning:

WARNINGS AND PRECAUTIONS SECTION

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:

INFORMATION FOR PATIENTS SECTION

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:

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor or dentist if:

OTC - STOP USE SECTION

  • 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,

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

Adults and children age 5 and older:

INSTRUCTIONS FOR USE SECTION

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:

INSTRUCTIONS FOR USE SECTION

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:

INSTRUCTIONS FOR USE SECTION

Do not use.

Other Information

OTHER SAFETY INFORMATION

  • Protect from humidity
  • Store at 15°C - 30°C (59°F - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

CankerMelts® 15mg carton of 20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199071benzocaine 15 MG Oral LozengePSN5
199071benzocaine 15 MG Oral LozengeSCD5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-700-20CankerMelts2 in 1 CARTONLOZENGE25
68229-700-20CankerMelts10 in 1 BLISTER PACKLOZENGE105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-700-20EA - Each68229-700cfb7e291-732f-4518-9cb3-bd82f25db20112023-10-16

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-70068229-700-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYPROPYLCELLULOSE9XZ8H6N6OHIACT
HYALURONIC ACIDS270N0TRQYIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM BICARBONATE8MDF5V39QOIACT
MAGNESIUM STEARATE70097M6I30IACT
XYLITOLVCQ006KQ1EIACT
METHYLCOBALAMINBR1SN1JS2WIACT
MALTODEXTRIN7CVR7L4A2DIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
BENZOCAINEU3RSY48JW5ACTIB
ACACIA5C5403N26OIACT

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
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
ndc (package): 68229-700-20
ndc (product): 68229-700
ndc11 (package): 68229070020
spl id: 4527197d-23f6-8029-e063-6394a90a04e0
spl set id: 070dae82-14c2-66d2-e063-6394a90ab259

Reported adverse events (FAERS/openFDA)#

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