Oral Pain Relief Gel

Manufacturer
Universal Distribution Center LLC
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:08

Label at a glance#

ProductOral Pain Relief
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years of age: should be supervised in the use of this product ■ children under 2 years of age: Do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Antiseptic

Use

INDICATIONS & USAGE SECTION

■ for the temporary relief of pain due to toothaches

■ to help protect against infection in minor oral irritation

Warnings

WARNINGS SECTION

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce 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 lightheadness
• 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 or other "caine" anesthetics

Do not use

OTC - DO NOT USE SECTION

■ more than directed

■ for more than 7 days unless directed by a physician or healthcare provider

Stop use and ask a physician if

OTC - STOP USE SECTION

■ swelling, rash or fever develops

■ irritation, pain or redness persists or worsens

■ symptoms do not improve in 7 days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider

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

■ children under 2 years of age: Do not use

Other information

SPL UNCLASSIFIED SECTION

■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted

■ do not use continuously

■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid, purified water, FD&C Yellow#5, FD&C Red#40

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral Pain Relief Gel

NET WT. 0.5 oz (14 g)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595155benzocaine 20 % / benzalkonium chloride 0.1 % Oral GelPSN4
1595155benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral GelSCD4
1595155benzalkonium chloride 0.1 % / benzocaine 20 % Oral GelSY4

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-060-012025-07-29C16284748780-13b156c62-2e7e-fb37-e063-e6dba90a4e07Oral Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-060-01Oral Pain Relief14 g in 1 TUBEGEL144
52000-060-01Oral Pain Relief1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-060ORAL PAIN RELIEF (BENZOCAINE AND BENZALKONIUM CHLORIDE) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]4Current NDC, Legacy NDC, 2 package rows20241212_baf0cf27-052e-4367-9a6e-75038b97a051.zip

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
52000-06052000-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Pain ReliefBENZOCAINE AND BENZALKONIUM CHLORIDEUniversal Distribution Center LLC18520f9b-4d35-1e9c-e063-6294a90aaa392025-10-30WarningsExact identifier
ndc (product): 52000-060
1cc60817-5170-4ea7-85f3-703acb3ac57fbaf0cf27-052e-4367-9a6e-75038b97a0512024-12-04WarningsExact identifier
spl id: 1cc60817-5170-4ea7-85f3-703acb3ac57f
spl set id: baf0cf27-052e-4367-9a6e-75038b97a051

Reported adverse events (FAERS/openFDA)#

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