FDA.reportPublic FDA data

Oral Anesthetic Liquid

Manufacturer
Meijer, Inc. | Lornamead Products | HK KOLMAR CANADA, INC
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:10:00

Label at a glance#

ProductOral Anesthetic Liquid
Active ingredientBENZOCAINE
Label structure8 sections

Indications and uses

Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures

Dosage and administration

Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age: adult supervision should be given in the use of this product children under 2 years of age: do not use for denture irritation apply a thin layer to the affected area; do not reinsert dental work unti...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20.0% (w/w)

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures

Warnings

WARNINGS SECTION

METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition 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

  • for teething
  • in children under 2 years of age

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a dentist or doctor

Stop use and ask doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist

  • children under 12 years of age: adult supervision should be given in the use of this product
  • children under 2 years of age: do not use
  • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Card R1Card R1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN5
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD5
308657benzocaine 20 % Mucous Membrane Topical SolutionSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0118-9Oral Anesthetic Liquid1 in 1 CARTONLIQUID15
79481-0118-9Oral Anesthetic Liquid14.7 g in 1 BOTTLELIQUID14.75

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
79481-011879481-0118-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BENZOCAINEU3RSY48JW5ACTIB
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
FD&C RED NO. 40WZB9127XOAIACT

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
Oral Anesthetic LiquidBENZOCAINEMeijer, Inc.0321c480-e150-421d-e063-6294a90ad6872025-08-12WarningsExact identifier
ndc (package): 79481-0118-9
ndc (product): 79481-0118
ndc11 (package): 79481011809
spl id: 3c30d3cc-98ea-fd46-e063-6394a90aed7f
spl set id: 0321c480-e150-421d-e063-6294a90ad687

Reported adverse events (FAERS/openFDA)#

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