LISTERINE ® ESSENTIAL CARE ® FLUORIDE ANTICAVITY TOOTHPASTE ORIGINAL GEL

Manufacturer: Johnson & Johnson Consumer Inc.
Effective date: 2021-09-24
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:34:51

Label at a glance#

ProductListerine Essential Care

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure10 sections

Dosage and administration

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician. children 2-6 years use a pea sized amount instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision. children under 2 years of age: as...

Storage and handling

Store at Room Temperature.

Contacts and useful links#

PhoneLabel contact888-222-0182

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician.
- children 2-6 years use a pea sized amount
- instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision.
children under 2 years of age: ask a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

Store at Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, menthol, sodium phosphate, xanthan gum, benzoic acid, flavor, mentha viridis (spearmint) leaf oil, disodium phosphate, blue 1, yellow 10

Questions?

OTC - QUESTIONS SECTION

call toll-free 888-222-0182 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LISTERINE ^®
ESSENTIAL CARE ^®
FLUORIDE ANTICAVITY TOOTHPASTE
ORIGINAL GEL

POWERFUL MINT GEL

FRESHENS BREATH
THE LISTERINE ^® WAY

Kills the Germs
That Cause Bad Breath
Helps Prevent Cavities
Removes Stains

NET WT. 4.2 OZ. (119 g)

Principal Display Panel - 119 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42002-411-09	2020-09-24	C162847	48780-1	ab0e2407-27ee-f274-e053-dbdaa90a6471	LISTERINE ® ESSENTIAL CARE ® FLUORIDE ANTICAVITY TOOTHPASTE ORIGINAL GEL
42002-411-09	2020-07-22	C162847	48780-1	ab0e2407-27ee-f274-e053-dbdaa90a6471	LISTERINE ® ESSENTIAL CARE ® FLUORIDE ANTICAVITY TOOTHPASTE ORIGINAL GEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	2
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	2
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	2
Carboxymethylcellulose Sodium, Unspecified Form	INACTIVE INGREDIENT	K679OBS311	2
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
Eucalyptol	INACTIVE INGREDIENT	RV6J6604TK	2
Fd&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	2
Menthol, Unspecified Form	INACTIVE INGREDIENT	L7T10EIP3A	2
Methyl Salicylate	INACTIVE INGREDIENT	LAV5U5022Y	2
Phosphoric Acid	INACTIVE INGREDIENT	E4GA8884NN	2
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	2
Sodium Phosphate	INACTIVE INGREDIENT	SE337SVY37	2
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	2
Spearmint Oil	INACTIVE INGREDIENT	C3M81465G5	2
Thymol	INACTIVE INGREDIENT	3J50XA376E	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

Listerine Essential Care
Sodium Monofluorophosphate
HYDRATED SILICA
GLYCERIN
POLYETHYLENE GLYCOL 1600
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
SACCHARIN SODIUM
EUCALYPTOL
METHYL SALICYLATE
THYMOL
PHOSPHORIC ACID
MENTHOL, UNSPECIFIED FORM
SODIUM PHOSPHATE
XANTHAN GUM
BENZOIC ACID
MENTHA SPICATA OIL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FLUORIDE ION
WATER
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42002-411	42002-411-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 1600	1212Z7S33A	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
EUCALYPTOL	RV6J6604TK	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
THYMOL	3J50XA376E	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
SODIUM PHOSPHATE	SE337SVY37	IACT
XANTHAN GUM	TTV12P4NEE	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
MENTHA SPICATA OIL	C3M81465G5	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	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 9 · 513 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Spearmint Oil	SPEARMINT OIL	C3M81465G5	CAPSULE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRASYNOVIAL	0.1 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	LIQUID / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAVENOUS		1294 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Fd&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Spearmint Oil	SPEARMINT OIL	C3M81465G5	PASTE, DENTIFRICE / DENTAL	27.6 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	FILM, SOLUBLE / ORAL	0.05 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SOLUTION / IRRIGATION	0.02 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	CREAM / TOPICAL		13 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / SOFT TISSUE		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRA-ARTICULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRALESIONAL		28 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Fd&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Fd&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Carboxymethylcellulose Sodium, Unspecified Form	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, COATED / ORAL	3.2 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Menthol, Unspecified Form	MENTHOL	L7T10EIP3A	JELLY / NASAL	32.5 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Menthol, Unspecified Form	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TROCHE / ORAL	28 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Menthol, Unspecified Form	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 31 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
ccbbd134-8885-0f49-e053-2a95a90a2ceb			a8c4de8b-44ff-46c1-85bc-430d2af1cbfd	2021-09-24	Warnings	Exact identifier spl id: ccbbd134-8885-0f49-e053-2a95a90a2ceb spl set id: a8c4de8b-44ff-46c1-85bc-430d2af1cbfd

Reported adverse events (FAERS/openFDA)#

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