HurriCaine

Manufacturer: Beutlich Pharmaceuticals, LLC | Speciality Pharma Manufacturing | Dental Technologies Inc.
Effective date: 2025-11-06
Label type: HUMAN OTC DRUG LABEL
Version: 51
Source: full-release
Hydrated at: 2026-06-01 01:42:46

Label at a glance#

ProductHurriCaine Topical Anesthetic Liquid

Active ingredientBENZOCAINE

Label structure12 sections

Indications and uses

for temporary relief of occasional minor irritation and pain associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Dosage and administration

Directions do not exceed recommended dosage adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute 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

store at 20°-25°C (68°-77°F)

Contacts and useful links#

PhoneLabel contact1-800-238-8542

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of occasional minor irritation and pain associated with:

canker sores
sore mouth and throat
minor injury of the mouth and gums
minor dental procedures
minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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

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 irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Do not use

OTC - STOP USE SECTION

Do not use

if imprinted seal under cap is broken or missing
for teething
in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

do not exceed recommended dosage

adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute 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

store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-238-8542

M-F: 8:00 a.m.- 4:30 p.m. ET

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0283-0569-31

1oz carton image

HURRICAINE®

Topical Anesthetic LIQUID

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

Made in the USA

1 fl. oz.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308657	benzocaine 20 % Mucous Membrane Topical Solution	PSN	51
808062	HurriCaine Oral Anesthetic 20 % Mucous Membrane Topical Solution	PSN	51
808062	benzocaine 200 MG/ML Mucous Membrane Topical Solution [Hurricaine]	SBD	51
308657	benzocaine 200 MG/ML Mucous Membrane Topical Solution	SCD	51
308657	benzocaine 20 % Mucous Membrane Topical Solution	SY	51
808062	Hurricaine 20 % Mucous Membrane Topical Solution	SY	51
808062	Hurricaine 200 MG/ML Mucous Membrane Topical Solution	SY	51

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0283-0569-02	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid
0283-0569-02	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid
0283-0569-17	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid
0283-0569-17	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid
0283-0569-31	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid
0283-0569-31	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid
0283-0569-72	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid
0283-0569-72	2024-01-30	C162847	48780-1	1030e365-2dfe-111a-e063-dadaa90a10e2	W/C Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0283-0569-02	HurriCaineTopical Anesthetic Liquid	2 g in 1 APPLICATOR	LIQUID	2	51
0283-0569-17	HurriCaineTopical Anesthetic Liquid	1 g in 1 PACKET	LIQUID	1	51
0283-0569-31	HurriCaineTopical Anesthetic Liquid	29.6 g in 1 BOTTLE, PLASTIC	LIQUID	29.6	51
0283-0569-72	HurriCaineTopical Anesthetic Liquid	72 g in 1 APPLICATOR	LIQUID	72	51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0283-0569-31	ML - Milliliter	0283-0569	1326f189-9c69-460f-a071-c36eae179397	1	2012-07-24
0283-0569-72	EA - Each	0283-0569	0e9c6d99-ad67-4acf-8ed5-6b7b6f579675	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	6
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	6
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	6
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	6

Products#

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

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

HurriCaine Topical Anesthetic Liquid
Benzocaine
POLYETHYLENE GLYCOL 400
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0283-0569	0283-0569-31, 0283-0569-17, 0283-0569-72, 0283-0569-02

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
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
50	2024-07-01	full-release	2026-06-01 00:14:35

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 100 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii+route 95 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route 95 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 95 equally ranked IID candidates

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
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fee9969d-ad1a-4f44-9741-a0a44c9e1128	2025-11-06	Warnings	Exact identifier ndc (package): 0283-0569-02 ndc (package): 0283-0569-31 ndc (package): 0283-0569-17 ndc (package): 0283-0569-72 ndc (product): 0283-0569 ndc11 (package): 00283056972 ndc11 (package): 00283056902 ndc11 (package): 00283056917 ndc11 (package): 00283056931 spl id: 42f260d7-63f7-4356-e063-6394a90a4676 spl set id: fee9969d-ad1a-4f44-9741-a0a44c9e1128

Reported adverse events (FAERS/openFDA)#

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