Label at a glance#

ProductORAL PAIN RELIEF

Active ingredientBENZOCAINE

Label structure9 sections

Indications and uses

• for the temporary relief of pain due to toothaches • to help protect against infection in minor oral irritation

Dosage and administration

• Adults and children 2 years of age and over: Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider • Children between 2 and 12 years of age: Should be supervised in the use of this product • Children under 2 years of age: Do not use

Storage and handling

• this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted • do not use continuosly • 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

Contacts and useful links#

Websitewww.universaldc.com

www.universaldc.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purposes

OTC - PURPOSE SECTION

Oral pain reliever

Uses

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 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

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider

Stop use and ask a physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. in case of overdose or allergic reaction, get medical help

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and over: Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider • Children between 2 and 12 years of age: Should be supervised in the use of this product • Children under 2 years of age: Do not use

Other information

STORAGE AND HANDLING SECTION

• this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted • do not use continuosly • 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, Fragrance, Polyethylene Glycol 400, Polyethylene Glycol 4000, Saccharin Sodium, Sorbic Acid, Water

SPL UNCLASSIFIED SECTION

COOLING COMFORT FORMULA

• FAST COOLING
• TOOTH & GUM COMFORT

For Pain Relief & Toothaches

Mfd for and Distributed by:

Universal Distribution Center LLC
330 Applegarth Road,
Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL PAIN RELIEF

DailyMed RxNorm Mappings#

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

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
52000-443-04	ORAL PAIN RELIEF	1 in 1 BOX	GEL	1		1
52000-443-04	ORAL PAIN RELIEF	11.9 g in 1 TUBE	GEL	11.9		1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

ORAL PAIN RELIEF
Benzocaine
AMMONIUM GLYCYRRHIZATE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 4000
SACCHARIN SODIUM
SORBIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52000-443	52000-443-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
AMMONIUM GLYCYRRHIZATE	3VRD35U26C	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYETHYLENE GLYCOL 4000	4R4HFI6D95	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBIC ACID	X045WJ989B	IACT
WATER	059QF0KO0R	IACT

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	BENZOCAINE	Universal Distribution Center LLC	e276ba37-46fb-4ed9-9ee1-c08a2a89704a	2026-01-20	Warnings	Exact identifier ndc (package): 52000-443-04 ndc (product): 52000-443 ndc11 (package): 52000044304 spl id: 804b78cd-d8a1-4548-807c-75bd7c52009d spl set id: e276ba37-46fb-4ed9-9ee1-c08a2a89704a

Reported adverse events (FAERS/openFDA)#

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

Fast-Acting ORAL PAIN RELIEF GEL