FDA.reportPublic FDA data

CANKER SORE HEALING DOTS

Manufacturer
Hyland's Inc.
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:45:01

Label at a glance#

ProductCANKER SORE HEALING DOTS
Active ingredientDAPHNE MEZEREUM BARK, SODIUM CHLORIDE, SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP, CAUSTICUM
Label structure8 sections

Indications and uses

Temporarily relieves the symptoms of sores and ulcers in mouth,discomfort of gums or tongue due to canker sores.

Dosage and administration

Children 2 years to under 6 years of age: Consult a licensed healthcare professional before using this product. Children 6 years to under 12 years of age: Dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. Adults and Children 12 years and over: Dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Borax 6X HPUS

canker sores, sores or ulcers in mouth

Calendula 6X HPUS

canker and mouth sores

Causticum 6X HPUS

discomfort of gums and cheek due to canker sores, sores in mouth

Mezereum 12X HPUS

canker sores, discomfort of tongue or gums due to canker sores

Natrum Muriaticum 6X HPUS

discomfort of gums and cheek due to canker sores, sores in mouth

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of sores and ulcers in mouth,discomfort of gums or tongue due to canker sores.

WARNINGS SECTION

As with any drug, ask doctor before use if pregnant or breast-feeding.

Do not use• more than directed  • if you have a known allergy to any ingredient in this product.

Consult a physician

SPL UNCLASSIFIED SECTION

Consult a physician if:

• symptoms persist for more than 72 hours or worsen

• swelling increases, rash or fever develops 

• irritation, pain or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Tamper Band Safety

SPL UNCLASSIFIED SECTION

Do not use if imprinted tamper band is broken or missing.

In case of emergency

SPL UNCLASSIFIED SECTION

contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Children 2 years to under 6 years of age: Consult a licensed healthcare professional before using this product.

Children 6 years to under 12 years of age: Dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Adults and Children 12 years and over: Dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

OTC - PURPOSE SECTION

Temporarily relieves the symptoms of sores and ulcers in mouth, discomfort of gums or tongue due to canker sores.

PRINCIPAL DISPLAY PANEL - 50 TABLET CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3343-1

HOMEOPATHIC

Natural

Relief

SINCE 1903

Hyland's ®

CANKER SORE*

HEALING DOTS

RELIEF TABLETS

BENZOCAINE FREE

GENTLE PAIN RELIEF

COATES AND SOOTHES

WITHOUT NUMBING

OR BURNING

FOR MOUTH SORES

& ABRASIONS

50 QUICK-DISSOLVING

TABLETS

ACTUAL SIZE

194 MG

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54973-3343-12022-10-20C16284748780-1e4f33bdf-9cdd-d8a0-e053-dadaa90a6e4eCanker Sore Healing Dots
54973-3343-22022-10-20C16284748780-1e4f33bdf-9cdd-d8a0-e053-dadaa90a6e4eCanker Sore Healing Dots
54973-3343-12022-07-29C16284748780-1e4f33bdf-9cdd-d8a0-e053-dadaa90a6e4eCanker Sore Healing Dots
54973-3343-22022-07-29C16284748780-1e4f33bdf-9cdd-d8a0-e053-dadaa90a6e4eCanker Sore Healing Dots

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
54973-334354973-3343-1, 54973-3343-2

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
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM BORATE91MBZ8H3QOACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CAUSTICUMDD5FO1WKFUACTIB

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
0812f0c1-ccc4-6586-e063-6394a90a49995928225b-c63c-acff-e053-2991aa0ae6532023-10-19WarningsExact identifier
spl set id: 5928225b-c63c-acff-e053-2991aa0ae653

Reported adverse events (FAERS/openFDA)#

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