FDA.reportPublic FDA data

HurriCaine

Manufacturer
Beutlich Pharmaceuticals, LLC | Dental Technologies Inc.
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
25
Source
full-release
Hydrated at
2026-06-01 00:31:27

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

do not exceed recommended dosage 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 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: consult a dentist or doctor

Storage and handling

Do not use if imprinted seal under cap is broken or missing store at 20°-25 C (68°-77° F)

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

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

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting
  • if sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dosage


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 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: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

  • Do not use if imprinted seal under cap is broken or missing
  • 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 0283-1886-31

HURRICAINE®

Topical Anesthetic LIQUID

20% Benzocaine Oral Anesthetic

PINA COLADA

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

Made in the USA

1 fl. oz. image of cartonimage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN25
808062HurriCaine Oral Anesthetic 20 % Mucous Membrane Topical SolutionPSN25
808062benzocaine 200 MG/ML Mucous Membrane Topical Solution [Hurricaine]SBD25
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD25
308657benzocaine 20 % Mucous Membrane Topical SolutionSY25
808062Hurricaine 20 % Mucous Membrane Topical SolutionSY25
808062Hurricaine 200 MG/ML Mucous Membrane Topical SolutionSY25

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-1886-31HurriCaineTopical Anesthetic Liquid29.6 g in 1 BOTTLE, PLASTICLIQUID29.625

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-1886HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]25Current NDC, Legacy NDC, 1 package rows20241030_f70fa3fc-cd65-4a80-9efd-129e98fd3998.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-1886-31ML - Milliliter0283-188695997612-3036-4406-9261-9d7d76533f7d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW55
BENZOCAINEACTIVE MOIETYU3RSY48JW55
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQ5
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY5

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
0283-18860283-1886-31

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
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML · Source PDF

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 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+dosage form
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSUSPENSION / ORAL400 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSUSPENSION / ORAL400 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+dosage form
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+dosage form
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+dosage form
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+dosage form
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+dosage form
38 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii+route
38 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
ndc (package): 0283-1886-31
ndc (product): 0283-1886
ndc11 (package): 00283188631
spl id: 259047a5-da5a-2029-e063-6294a90a8db8
spl set id: f70fa3fc-cd65-4a80-9efd-129e98fd3998

Reported adverse events (FAERS/openFDA)#

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