Walgreens Mouth Sore Relief

Manufacturer
Walgreens | Lornamead Products | HK Kolmar Canada, Inc
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:10:02

Label at a glance#

ProductWalgreens Mouth Sore Relief
Active ingredientBENZOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

OTC - PURPOSE SECTION

Oral anesthetic/analgesic

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to the canker sores, minor irritation of the mouth and gums caused by dentures or othodontic appliances, or minor injury of the mouth or gums

WARNINGS SECTION

Methemoglobinemia warning: use of this product may cuase methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oygen 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:

  • plae, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness of 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and over: to assure formation of long0lasting film coating, dry affected area and apply medication undiluted with a cotton swab or fingertip; allow a few seconds for coating to for; use up to 4 times daily, or as directed by a dentist or doctor

children under 12 years of age should be supervised in the use of this product

children under 2 years of age: do not use

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacylamide/acrylates/butylaminoethyl/methylacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil , SD alcohol 38B, sucralose, tannic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2824635R1 WLG Mouth Sore Relief2824635R1 WLG Mouth Sore Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN4
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD4
308657benzocaine 20 % Mucous Membrane Topical SolutionSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5334-00Walgreens Mouth Sore Relief1 in 1 BLISTER PACKLIQUID14
0363-5334-00Walgreens Mouth Sore Relief14.7 mL in 1 BOTTLELIQUID14.74

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-53340363-5334-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
ndc (package): 0363-5334-00
ndc (product): 0363-5334
ndc11 (package): 00363533400
spl id: 3c30f23d-25d3-0a60-e063-6394a90a5328
spl set id: 253d7ea2-e48e-c7d7-e063-6394a90ae001

Reported adverse events (FAERS/openFDA)#

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