Topical Anesthetic Banana Flavor Gel

Manufacturer: Patterson Dental | DSHealthcare | DENTSPLY Caulk
Effective date: 2010-05-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:08:55

Label at a glance#

ProductTopical Anesthetic Banana

Active ingredientBenzocaine

Label structure7 sections

Label contents#

Full prescribing information#

INGREDIENTS

SPL UNCLASSIFIED 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.

CAUTION

SPL UNCLASSIFIED SECTION

Contains FD&C Yellow #5 (tartrazine) which may cause an allergenic response. Federal law prohibits dispensing without a prescription.

WARNING

WARNINGS 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
Corporate Office
1031 Mendota Heights Road
Saint Paul, MN 55120

PATTERSON
DENTAL /
Montréal Québec
H3M 3E6

PRINCIPAL DISPLAY PANEL - 29.6 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PATTERSON
DENTAL

Topical Anesthetic

Banana Flavor Gel
Contains 20% Benzocaine

For Professional Use Only
Net Contents 1 fl oz (29.6 mL)

Reorder Number
089-9989

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238910	benzocaine 20 % Oral Gel	PSN	1
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	1
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	1

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
50227-2116-1	2019-10-21	C162847	48780-1	956ca0cb-301f-486a-e053-dbdaa90ad200	Topical Anesthetic Banana Flavor Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50227-2116-1	Topical Anesthetic Banana	34 g in 1 JAR	GEL, DENTIFRICE	34		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50227-2116	TOPICAL ANESTHETIC (BENZOCAINE) GEL, DENTIFRICE [PATTERSON DENTAL]	1	Legacy NDC, 1 package rows	20100710_f4fdfcaf-aa95-45a8-ba91-7a8716f6f3d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1

Products#

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

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

Topical Anesthetic Banana
Benzocaine
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
SACCHARIN SODIUM
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50227-2116	50227-2116-1

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
Benzocaine	U3RSY48JW5	ACTIB
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
FD&C RED NO. 40	WZB9127XOA	IACT

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 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CREAM / TOPICAL		396 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, COATED / ORAL	0.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SPRAY, METERED / NASAL		96 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRAMUSCULAR		56 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRASYNOVIAL		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / SOFT TISSUE		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRA-ARTICULAR		56 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CAPSULE / ORAL		576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		60 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, DELAYED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRAMUSCULAR		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 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
69850139-6b9d-4bcd-b448-8a2fdb0bbfa5			f4fdfcaf-aa95-45a8-ba91-7a8716f6f3d8	2010-05-13	Warnings	Exact identifier spl id: 69850139-6b9d-4bcd-b448-8a2fdb0bbfa5 spl set id: f4fdfcaf-aa95-45a8-ba91-7a8716f6f3d8

Reported adverse events (FAERS/openFDA)#

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