FDA.reportPublic FDA data

Oral Pain Relief Gel

Manufacturer
Sled Distribution, LLC
Effective date
2022-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:54

Label at a glance#

ProductOral Pain Relief Gel
Active ingredientBENZOCAINE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20% (w/w)

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

WARNINGS SECTION

Warnings

For oral use only.

OTC - DO NOT USE SECTION

stop use and ask a doctor if get any discomfort.

OTC - STOP USE SECTION

Stop use and ask a dentist or doctor if

  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, fever or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If accidentally swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children (2 years and older):

Dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Polyethylene Glycol, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benzocaine 20% | Oral Anesthetic

NET WT 0.75 g

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN1
238910benzocaine 0.2 MG/MG Oral GelSCD1
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1

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
81417-121-012023-07-28C16284748780-10191ceaa-7035-198a-e063-dbdaa90aec3eOral Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81417-121-01Oral Pain Relief Gel0.75 g in 1 BAGGEL0.751
81417-121-01Oral Pain Relief Gel1 in 1 PACKAGEGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-121ORAL PAIN RELIEF GEL (BENZOCAINE 20%) GEL [SLED DISTRIBUTION, LLC]1Legacy NDC, 2 package rows20220325_43af5b3f-4cda-4317-8c83-ff8d35786cb5.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81417-12181417-121-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
BENZOCAINEU3RSY48JW5ACTIB

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
8a1fca56-0c73-4509-80fe-4dea3c764c5243af5b3f-4cda-4317-8c83-ff8d35786cb52022-03-25WarningsExact identifier
spl id: 8a1fca56-0c73-4509-80fe-4dea3c764c52
spl set id: 43af5b3f-4cda-4317-8c83-ff8d35786cb5

Reported adverse events (FAERS/openFDA)#

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