ATOPALM Oral Pain Relief Gel

Manufacturer: NeoPharm, USA
Effective date: 2012-02-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:54

Label at a glance#

ProductATOPALM Oral Pain Relief

Active ingredientBENZOCAINE

Label structure8 sections

Dosage and administration

cut open tip of tube at score mark Adults and children 2 years of age and older apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or a doctor. Children under 12 years of age should be supervised in the use of this product. Children under 2 years of age ask a dentist or a doctor.

Contacts and useful links#

PhoneLabel contact1-855-286-7256

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 10%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to toothaches.

Warnings

WARNINGS SECTION

Allergy alert:

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

Do not use

OTC - DO NOT USE SECTION

more than directed
for more than 7 days unless told to do so by a dentist or a doctor.

Stop use and ask a doctor if

OTC - STOP USE SECTION

swelling, rash or fever develops
irritation, pain, or redness persists or worsens.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

cut open tip of tube at score mark

Adults and children 2 years of age and older

apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or a doctor.

Children under 12 years of age

should be supervised in the use of this product.

Children under 2 years of age

ask a dentist or a doctor.

Other information

OTHER SAFETY INFORMATION

do not use if tube tip is cut prior to opening
this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

PEG-400, PEG-6000, Glycerin, Sodium Saccharin, Sorbic Acid, Flavor

Questions or information?

OTC - QUESTIONS SECTION

Call toll free 1-855 ATOPALM – (1-855-286-7256)

Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATOPALM Oral Pain Relief Gel

Fast Temporary Relief of Pain Due to Toothache

Benzocaine 10%

Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
Made in Korea

Atopalm Oral Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1243899	ATOPALM Oral Pain Relief 10 % Oral Gel	PSN	1
198488	benzocaine 10 % Oral Gel	PSN	1
1243899	benzocaine 0.1 MG/MG Oral Gel [Atopalm Oral Pain Relief]	SBD	1
198488	benzocaine 0.1 MG/MG Oral Gel	SCD	1
1243899	Atopalm Oral Pain Relief 0.1 MG/MG Oral Gel	SY	1
1243899	Atopalm Oral Pain Relief 10 % Oral Gel	SY	1
198488	benzocaine 10 % 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
51141-0236-7	2019-11-13	C162847	48780-1	97449f38-d54a-f6ea-e053-dbdaa90aa703	ATOPALM Oral Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51141-0236-7	ATOPALM Oral Pain Relief	1 in 1 BOX	GEL	1		1
51141-0236-7	ATOPALM Oral Pain Relief	7 g in 1 TUBE	GEL	7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51141-0236	ATOPALM ORAL PAIN RELIEF (BENZOCAINE) GEL [NEOPHARM, USA]	1	Legacy NDC, 2 package rows	20120206_b123d1c9-b461-4759-88db-7934ee7fafdd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

ATOPALM Oral Pain Relief
BENZOCAINE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
GLYCERIN
SACCHARIN SODIUM
SORBIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51141-0236	51141-0236-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
GLYCERIN	PDC6A3C0OX	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBIC ACID	X045WJ989B	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 · 179 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET / SUBLINGUAL	70 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, DELAYED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 15 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET / SUBLINGUAL	0.16 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 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	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 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
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, EXTENDED RELEASE / ORAL		250 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	CAPSULE, DELAYED RELEASE PELLETS / ORAL		135 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 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
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	INSERT / VAGINAL	0.06 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET / BUCCAL	70 mg		Exact identifier — unii candidate 15 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
c4960e55-2361-47fe-a60d-bf0fbf2d0c66			b123d1c9-b461-4759-88db-7934ee7fafdd	2012-02-06	Warnings	Exact identifier spl id: c4960e55-2361-47fe-a60d-bf0fbf2d0c66 spl set id: b123d1c9-b461-4759-88db-7934ee7fafdd

Reported adverse events (FAERS/openFDA)#

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