Top Care

Manufacturer: TOPCO Assoc. LLC | Lornamead Products
Effective date: 2025-11-14
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:16:09

Label at a glance#

ProductTop Care Enamel Guard

Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE

Label structure8 sections

Indications and uses

aids in reducing sensitivity aids in the prevention of dental cavities

Dosage and administration

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Do not swallow.

Label contents#

Full prescribing information#

Active ingredients / Purpose

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.15% w/v fluoride ion.........................Anticavity

Uses

OTC - PURPOSE SECTION

aids in reducing sensitivity
aids in the prevention of dental cavities

WARNINGS SECTION

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Other Information

OTHER SAFETY INFORMATION

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Artwork

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1038841	Potassium nitrate/Sodium fluoride (Toothpaste)	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG Toothpaste	SCD Active
1038929	Potassium nitrate/Sodium fluoride (Toothpaste)	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	9
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	9
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	9
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-186-69	2021-03-02	C162847	48780-1	ab0e2407-3145-f274-e053-dbdaa90a6471	5820186 Topco Enamel Guard
36800-186-69	2020-09-27	C162847	48780-1	ab0e2407-3145-f274-e053-dbdaa90a6471	5820186 Topco Enamel Guard
36800-186-69	2020-09-25	C162847	48780-1	ab0e2407-3145-f274-e053-dbdaa90a6471	5820186 Topco Enamel Guard
36800-186-69	2020-07-22	C162847	48780-1	ab0e2407-3145-f274-e053-dbdaa90a6471	5820186 Topco Enamel Guard

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-681-19	Top CareEnamel Guard	113 g in 1 TUBE	PASTE, DENTIFRICE	113		9
36800-681-19	Top CareEnamel Guard	1 in 1 CARTON	PASTE, DENTIFRICE	1		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
POTASSIUM NITRATE	ACTIVE INGREDIENT	RU45X2JN0Z	2
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SODIUM METHYL COCOYL TAURATE	INACTIVE INGREDIENT	JVL98CG53G	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	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 · 17 matching rows.

Top Care Enamel Guard
Fluoride
WATER
SACCHARIN SODIUM
SORBITOL
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
SODIUM HYDROXIDE
GLYCERIN
XANTHAN GUM
HYDRATED SILICA
COCAMIDOPROPYL BETAINE
SODIUM METHYL COCOYL TAURATE
SODIUM FLUORIDE
FLUORIDE ION
POTASSIUM NITRATE
NITRATE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-681	36800-681-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
GLYCERIN	PDC6A3C0OX	IACT
XANTHAN GUM	TTV12P4NEE	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
SODIUM METHYL COCOYL TAURATE	JVL98CG53G	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
POTASSIUM NITRATE	RU45X2JN0Z	ACTIB

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 · 146 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 58 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAMUSCULAR	20.3 %w/v		Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	PASTE / DENTAL	0.6 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 58 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 58 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 58 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
SODIUM METHYL COCOYL TAURATE	SODIUM METHYL COCOYL TAURATE	JVL98CG53G	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 58 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAMUSCULAR		406 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / DENTAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 72 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 58 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 72 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
Top Care Enamel Guard	FLUORIDE	TOPCO Assoc. LLC	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	2025-11-14	Warnings	Exact identifier ndc (package): 36800-681-19 ndc (product): 36800-681 ndc11 (package): 36800068119 spl id: 4395839a-f420-fe45-e063-6394a90a33d3 spl set id: 8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c

Reported adverse events (FAERS/openFDA)#

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