Label: BENZOCAINE 20% solution

  • NDC Code(s): 0121-1077-01, 0121-1077-25
  • Packager: PAI Holdings, LLC dba PAI Pharma
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2026

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral Anesthetic

  • Uses

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

  • 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 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

    • for teething
    • in children under 2 years of age

    When using this product

    • 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

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

    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

    • 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 ageshould be supervised in the use of the product
    children under 2 years of agedo not use
  • Other information

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

    flavor, polyethylene glycol, sucralose

  • Questions or comments?

    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

    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)

    Benzocaine pouch
  • Principal Display Panel - carton

    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

    Benzocaine carton
  • INGREDIENTS AND APPEARANCE
    BENZOCAINE 20% 
    benzocaine 20% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1077-2525 in 1 CARTON03/20/2026
    1NDC:0121-1077-011 in 1 POUCH
    10.5 mL in 1 APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/20/2026
    Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)