Benzocaine 20% Solution

Manufacturer: PAI Holdings, LLC dba PAI Pharma
Effective date: 2026-03-25
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:51:52

Label at a glance#

ProductBenzocaine 20%

Active ingredientBENZOCAINE

Label structure10 sections

Indications and uses

for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

Dosage and administration

Read Directions on side panel for how to use adults and children 2 years of age and older apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. children under 12 years of age should be supervised in the use of the product children under 2 years of age do not use

Storage and handling

do not use if foil pouch is torn or open store at 15-30°C (59-86°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-845-8210

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

Warnings

WARNINGS SECTION

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

Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Do not use

OTC - DO NOT USE SECTION

for teething
in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

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

Stop using and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Read Directions on side panel for how to use

adults and children 2 years of age and older	apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
children under 12 years of age	should be supervised in the use of the product
children under 2 years of age	do not use

Other information

STORAGE AND HANDLING SECTION

do not use if foil pouch is torn or open
store at 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, polyethylene glycol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-845-8210

*This product is not manufactured or distributed by Beutlich Pharmaceuticals. LLC, the distributor of HurriCaine ONE®, and owner of the registered trademark HurriCaine ONE®, [Beutlich Pharmaceuticals, LLC does not make or license PAI's product.]

Principal Display Panel - pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-1077-01

BENZOCAINE 20% SOLUTION

Individually Wrapped Single-Unit Dose Applicator
20% Benzocaine Oral Anesthetic

CHERRY FLAVOR

Store at 15° - 30°C (59 - 86°F)

Warnings

METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia
a rare but serious condition that must be treated promptly because it reduces the amount of
oxygen carried in the blood. This can occur even if you have used this product before. stop use and
seek immediate medical attention if you or your 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.

Please refer to Drug Facts for complete product information.

1 Single-Unit Dose Applicator 0.017 fl oz (0.5 mL)

Principal Display Panel - carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-1077-25

PAI Pharma Compare to the active ingredient in HurriCaine ONE®

BENZOCAINE 20%
SOLUTION

Individually Wrapped Single-Unit Dose Applicator
20% Benzocaine Oral Anesthetic

CHERRY FLAVOR

25 Single-Unit Dose Applicators
0.017 fl. oz. (0.5 mL) EACH
0.425 fl. oz (12.5 mL) TOTAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308657	benzocaine 20 % Mucous Membrane Topical Solution	PSN	4
308657	benzocaine 200 MG/ML Mucous Membrane Topical Solution	SCD	4
308657	benzocaine 20 % Mucous Membrane Topical Solution	SY	4

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	SPL version
0121-1077-01	Benzocaine 20%	1 in 1 POUCH	SOLUTION	1	4
0121-1077-01	Benzocaine 20%	0.5 mL in 1 APPLICATOR	SOLUTION	0.5	4
0121-1077-25	Benzocaine 20%	25 in 1 CARTON	SOLUTION	25	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1077-01	EA - Each	0121-1077	463d4083-6886-4ef3-81c8-72e6ce3353c8	1	2026-04-20
0121-1077-25	EA - Each	0121-1077	4bc3ba88-92f7-4ef2-9b52-2bd6f5179c10	1	2026-04-20

Products#

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

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

Benzocaine 20%
BENZOCAINE
POLYETHYLENE GLYCOL 400
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0121-1077	0121-1077-01, 0121-1077-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SUCRALOSE	96K6UQ3ZD4	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
Benzocaine 20%	BENZOCAINE 20%	PAI Holdings, LLC dba PAI Pharma	7fbce9a5-00dc-4a4a-8709-ab752bdf2f59	2026-03-25	Warnings	Exact identifier ndc (package): 0121-1077-25 ndc (package): 0121-1077-01 ndc (product): 0121-1077 ndc11 (package): 00121107725 ndc11 (package): 00121107701 spl id: 83139f6d-1d4d-47d5-8da5-5dad5b9fe3b7 spl set id: 7fbce9a5-00dc-4a4a-8709-ab752bdf2f59

Reported adverse events (FAERS/openFDA)#

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