Benzo-Jel

Manufacturer: Henry Schein Inc
Effective date: 2015-04-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:20:47

Label at a glance#

ProductBenzo-Jel Bubble Gum

Active ingredientBenzocaine

Label structure7 sections

Storage and handling

Store at controlled room temperature 59°-86°F (15°-30°C). Do not use on people with known allergies to benzocaine and PABA compounds.

Label contents#

Full prescribing information#

INGREDIENTS

SPL UNCLASSIFIED SECTION

Each gram of Benzo-Jel™ 20% benzocaine gel contains between 180-220 mg benzocaine USP, in a water soluble base of PEG 3350 USP, PEG 400 USP, flavor, Sodium Saccharin USP, and FD&C Red #28.

USUAL DOSAGE

DOSAGE & ADMINISTRATION SECTION

For oral mucosal use only as directed by a dentist.

WARNING

WARNINGS SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59°-86°F (15°-30°C). Do not use on people with known allergies to benzocaine and PABA compounds.

CAUTION

SPL UNCLASSIFIED SECTION

Federal law (USA) prohibits dispensing without prescription.

SPL UNCLASSIFIED SECTION

Reorder #101-9442

1731025LA (R 5/19/10)

NDC# 0404-9442-01

Distributed By:
HENRY SCHEIN INC.
Melville, NY 11747 Made in USA

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HENRY SCHEIN^®

BENZO-JEL™
TOPICAL ANESTHETIC GEL

Bubble Gum

20% Benzocaine
FOR PROFESSIONAL USE ONLY
1 FL. OZ. (29.6 mL)

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

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
0404-9442-01	2020-01-31	C162847	48780-1	9d75b9d0-719b-f424-e053-dadaa90a57ce	BENZO-JEL™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9442-01	Benzo-Jel Bubble Gum	29.6 mL in 1 JAR	GEL	29.6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9442	BENZO-JEL BUBBLE GUM (BENZOCAINE) GEL [HENRY SCHEIN INC]	1	Legacy NDC, 1 package rows	20150513_770982a9-c0fc-43ca-88cc-e6c67c51891b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

Benzo-Jel Bubble Gum
Benzocaine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0404-9442	0404-9442-01

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
Benzocaine	U3RSY48JW5	ACTIB

Source Document#

Source XML

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
cd456b40-4086-4be4-9253-f11a1f2d8a24			770982a9-c0fc-43ca-88cc-e6c67c51891b	2015-04-30	Warnings	Exact identifier spl id: cd456b40-4086-4be4-9253-f11a1f2d8a24 spl set id: 770982a9-c0fc-43ca-88cc-e6c67c51891b

Reported adverse events (FAERS/openFDA)#

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