FDA.reportPublic FDA data

Lollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine

Manufacturer
Centrix, Inc. | Centrix Inc
Effective date
2025-10-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:41:58

Label at a glance#

ProductLolliCaine Bubble Gum
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

Do not exceed recommended dosage. Adults and children 2 years of age and older:  Apply to affected area up to 4 times daily or as directed by 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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of occasional minor irritation and pain, associated with:

  • Sore mouth and throat
  • Ulcers
  • Minor dental procedures
  • Needle punctures
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

WARNINGS SECTION

For external use only

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 any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, 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

Avoid contact with eyes

Ask a doctor before use

  • If pregnant or breastfeeding

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 2 years of age and older: Apply to affected area up to 4 times daily or as directed by 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

OTHER SAFETY INFORMATION

Store at 59° to 86º F (15º to 30º C)

Questions or comments?

OTC - QUESTIONS SECTION

800.235.5862 | centrixdental.com

CENTRIX INCORPORATED
770 River Road
Shelton, CT 06484 USA
Toll Free (USA): 800.235.5862
CENTRIXDENTAL.COM

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bubble Gum flavor contains:PEG-8, PEG-75, sodium saccharin

Cherry flavor contains:Cherry flavor, PEG-8, PEG-75, sodium saccharin

Mint flavor contains: Mint flavor, PEG-8, PEG-75, sodium saccharin

Pina Colada flavor contains:PEG-8, PEG-75, PinaColada flavor, sodium saccharin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LolliCaine-PIN_page-0001LolliCaine-PIN_page-0001LolliCaine-MNT_page-0001LolliCaine-MNT_page-0001LolliCaine-CHR_page-0001LolliCaine-CHR_page-0001Lollicaine-BBG_page-0001Lollicaine-BBG_page-0001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN6
1942189LolliCaine 20 % Oral GelPSN6
1942189benzocaine 0.2 MG/MG Oral Gel [LolliCaine]SBD6
238910benzocaine 0.2 MG/MG Oral GelSCD6
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY6
1942189LolliCaine 0.2 MG/MG Oral GelSY6
1942189LolliCaine 20 % Dental GelSY6

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60640-8800-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-8800-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9000-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9000-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9200-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9200-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9400-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9400-12025-05-16C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-8800-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-8800-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9000-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9000-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9200-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9200-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9400-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine
60640-9400-12023-01-30C16284748780-1f386c64a-2285-0266-e053-dadaa90a7c1aLollicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60640-8800-1LolliCaine Bubble Gum120 in 1 CARTONGEL, DENTIFRICE1206
60640-8800-1LolliCaine Bubble Gum0.4 g in 1 DOSE PACKGEL, DENTIFRICE0.46
60640-9000-1LolliCaine Cherry0.4 g in 1 DOSE PACKGEL, DENTIFRICE0.46
60640-9000-1LolliCaine Cherry120 in 1 CARTONGEL, DENTIFRICE1206
60640-9200-1LolliCaine Mint120 in 1 CARTONGEL, DENTIFRICE1206
60640-9200-1LolliCaine Mint0.4 g in 1 DOSE PACKGEL, DENTIFRICE0.46
60640-9400-1LolliCaine Pina Colada120 in 1 CARTONGEL, DENTIFRICE1206
60640-9400-1LolliCaine Pina Colada0.4 g in 1 DOSE PACKGEL, DENTIFRICE0.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60640-8800-1EA - Each60640-8800d949c4ab-ac0d-4872-8095-dd0f6f13f53a12021-08-05
60640-9000-1EA - Each60640-9000ac455118-fb68-4ec4-af4b-e2e120e050e212021-08-05
60640-9200-1EA - Each60640-92008aed0cd4-c527-4de6-860f-028cf12225d212021-08-05
60640-9400-1EA - Each60640-94004824c90d-f324-4f4c-8ecf-d503a1cb922e12021-08-05

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60640-880060640-8800-1
60640-900060640-9000-1
60640-920060640-9200-1
60640-940060640-9400-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-8B697894SGQIACT
PEG-75G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB
PEG-8B697894SGQIACT
PEG-75G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB
PEG-8B697894SGQIACT
PEG-75G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB
PEG-8B697894SGQIACT
PEG-75G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-05-14full-release2026-06-01 01:01:10

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
LolliCaine Bubble GumBENZOCAINECentrix, Inc.56ae3a84-6bca-4906-a03d-9d755e1fba3b2025-10-24WarningsExact identifier
ndc (package): 60640-9200-1
ndc (package): 60640-9000-1
ndc (package): 60640-9400-1
ndc (package): 60640-8800-1
ndc (product): 60640-9200
ndc (product): 60640-9000
ndc (product): 60640-8800
ndc (product): 60640-9400
ndc11 (package): 60640900001
ndc11 (package): 60640880001
ndc11 (package): 60640940001
ndc11 (package): 60640920001
spl id: 41ee7ce6-1b54-c719-e063-6394a90a48ca
spl set id: 56ae3a84-6bca-4906-a03d-9d755e1fba3b

Reported adverse events (FAERS/openFDA)#

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