Oral Pain Relief Gel

Manufacturer: Sled Distribution, LLC
Effective date: 2024-01-15
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:07:17

Label at a glance#

ProductOral Pain Relief Gel

Active ingredientBENZOCAINE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20% (w/w)

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

INDICATIONS & USAGE SECTION

Uses 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 - STOP USE SECTION

Stop use and ask a doctor if get any discomfort.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Polyethylene Glycol, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238910	benzocaine 20 % Oral Gel	PSN	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81417-001-01	Oral Pain Relief Gel	0.75 g in 1 POUCH	GEL	0.75		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81417-001	ORAL PAIN RELIEF GEL (BENZOCAINE 20%) GEL [SLED DISTRIBUTION, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20240116_e7391302-831e-14dc-e053-2a95a90ac236.zip

Products#

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

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

Oral Pain Relief Gel
Benzocaine 20%
POLYETHYLENE GLYCOL, UNSPECIFIED
BENZOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81417-001	81417-001-01

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
Name	UNII	Kind
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Pain Relief Gel	BENZOCAINE 20%	Sled Distribution, LLC	e7391302-831e-14dc-e053-2a95a90ac236	2024-01-15	Warnings	Exact identifier ndc (package): 81417-001-01 ndc (product): 81417-001 ndc11 (package): 81417000101 spl id: 0f004372-e6f5-c2b0-e063-6394a90ad29c spl set id: e7391302-831e-14dc-e053-2a95a90ac236

Reported adverse events (FAERS/openFDA)#

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