Topical Anesthetic

Manufacturer
Patterson Dental Supply Inc
Effective date
2012-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:35

Label at a glance#

ProductTopical Anesthetic Cherry
Active ingredientBenzocaine
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

INGREDIENTS

INACTIVE INGREDIENT SECTION

Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40.

USUAL DOSAGE

DOSAGE & ADMINISTRATION SECTION

For oral mucosal use only as directed by a dentist.

INDICATIONS & USAGE SECTION

CAUTION

OTC - PURPOSE SECTION

Federal law prohibits dispensing without a prescription.

WARNING

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

HOW SUPPLIED SECTION

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86°F (15-30°C).

SPL UNCLASSIFIED SECTION

MADE IN U.S.A.
Distributed by:
PATTERSON DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PATTERSON
DENTAL

NDC#50227-2115-1

Topical Anesthetic

Cherry Flavor Gel

Contains 20% Benzocaine

For Professional Use Only

Net Contents 1 fl oz (29.6 mL)

Reorder Number
089-9997

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label
PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN1
238910benzocaine 0.2 MG/MG Oral GelSCD1
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50227-2115-12019-11-13C16284748780-197449f38-bf30-f6ea-e053-dbdaa90aa703Patterson Topical Anesthetic Cherry Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50227-2115-1Topical Anesthetic Cherry29.6 g in 1 JARGEL29.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50227-2115TOPICAL ANESTHETIC CHERRY (BENZOCAINE) GEL [PATTERSON DENTAL SUPPLY INC]1Legacy NDC, 1 package rows20120502_3e2b5f80-203a-41cf-bd7c-d118578a5fd3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5P1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQ1
Saccharin Sodium DihydrateINACTIVE INGREDIENTSB8ZUX40TY1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50227-211550227-2115-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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 · 98 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAVENOUS0.5 mlExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / TOPICAL11100 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, CHEWABLE / ORAL15 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRAMUSCULAR87 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQAEROSOL, POWDER / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii candidate
28 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / RECTAL5704 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
28 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRALESIONAL87 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRASYNOVIAL3 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / OPHTHALMIC46 mgExact identifier — unii candidate
36 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
28 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 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
33c213ed-f380-4b4b-90cd-8ead44c7d8a53e2b5f80-203a-41cf-bd7c-d118578a5fd32012-04-06WarningsExact identifier
spl id: 33c213ed-f380-4b4b-90cd-8ead44c7d8a5
spl set id: 3e2b5f80-203a-41cf-bd7c-d118578a5fd3

Reported adverse events (FAERS/openFDA)#

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