Oral B Instant Pain Relief

Manufacturer: Health-Tech, Inc.
Effective date: 2010-05-28
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:24:57

Label at a glance#

ProductOral B Instant Pain Relief

Active ingredientBenzocaine

Label structure11 sections

Indications and uses

Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures

Dosage and administration

Remove cap-, squeeze gel onto applicator Adults and children 2 years of age and older, apply to the affected area 4 times per day or as directed by a doctor/dentist Children under 2 years of age; consult a doctor/dentist For Denture wearers Remove Dentures Apply thin layer to affected area Do not reinsert dental work until irritation is relieved Rinse mouth well before reinserting dentures

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral anesthetic

Uses

SPL UNCLASSIFIED SECTION

Temporarily relieves pain associated with the following mouth and gum irritations:

toothache
sore gums
canker sores
braces
minor dental procedures
dentures

Warnings

WARNINGS SECTION

Allergy Alert: do not use this pr9oduct if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other :caine" anesthetics.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes
Do not exceed recommended dosage
Do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if:

OTC - STOP USE SECTION

sore mouth symptoms do not improve in 7 days
Irritation, pain or redness persist or worsens
Swelling, pain or fever develops

Directions:

SPL UNCLASSIFIED SECTION

Remove cap-, squeeze gel onto applicator
Adults and children 2 years of age and older, apply to the affected area 4 times per day or as directed by a doctor/dentist
Children under 2 years of age; consult a doctor/dentist

For Denture wearers

Remove Dentures
Apply thin layer to affected area
Do not reinsert dental work until irritation is relieved
Rinse mouth well before reinserting dentures

Other information:

SPL UNCLASSIFIED SECTION

Store between 20⁰ to 25⁰ C (68⁰ to 77⁰ F) Do not refrigerate
Do not purcahse if package has been opened

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, carbomer 974P, FD and C green 5, Flavor, glycerin, Methylparaben, Polyethylene glycol, PEG 400, PEG 600, Sodium Saccharin

Oral B Pain gel label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM27oral B tooth pain gel label

Oral B pain gel blister

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM28oral B tooth pain gel blister

Oral B shipper label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM29Oral B shipper label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238910	benzocaine 20 % Oral Gel	PSN	3
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	3
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
48871-008-01	2019-10-21	C162847	48780-1	956f9ecf-d395-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48871-008-01	Oral B Instant Pain Relief	12 in 1 BOX	GEL	12		3
48871-008-01	Oral B Instant Pain Relief	6 in 1 CARTON	GEL	6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48871-008	ORAL B INSTANT PAIN RELIEF (BENZOCAINE) GEL [HEALTH-TECH, INC.]	3	Legacy NDC, 2 package rows	20100701_04f67d13-d0fa-409c-94bb-0f0e780bc812.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	3
benzocaine	ACTIVE MOIETY	U3RSY48JW5	3
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	K61870Z308	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	3
Polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	3
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	3
Polyethylene Glycol 600	INACTIVE INGREDIENT	NL4J9F21N9	3
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	3

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Oral B Instant Pain Relief
benzocaine
benzyl alcohol
Glycerin
methylparaben
Polyethylene glycol
Polyethylene glycol 400
Polyethylene Glycol 600
Saccharin Sodium
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48871-008	48871-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Benzocaine	U3RSY48JW5	ACTIB
benzyl alcohol	LKG8494WBH	IACT
Glycerin	PDC6A3C0OX	IACT
methylparaben	A2I8C7HI9T	IACT
Polyethylene glycol	3WJQ0SDW1A	IACT
Polyethylene glycol 400	B697894SGQ	IACT
Polyethylene Glycol 600	NL4J9F21N9	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	K61870Z308	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 5 · 283 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 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
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAMUSCULAR		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE / ORAL		1742 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 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
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0ef7f255-aca0-4237-aa21-267780aca1d1			04f67d13-d0fa-409c-94bb-0f0e780bc812	2010-05-28	Warnings	Exact identifier spl id: 0ef7f255-aca0-4237-aa21-267780aca1d1 spl set id: 04f67d13-d0fa-409c-94bb-0f0e780bc812

Reported adverse events (FAERS/openFDA)#

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