FDA.reportPublic FDA data

Topco Associates LLC

Manufacturer
Topco Associates LLC | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:52:31

Label at a glance#

ProductTopco Associates LLC Maximum Strength
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure7 sections

Indications and uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention of dental cavities

Dosage and administration

Adults and children 12 years of age and older: apply at least a 1-inch strip of product onto a soft bristle toothbrush brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 tims a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimiza swallowing. Spit out after brushing. children under 12 years of age: Consult a d...

Label contents#

Full prescribing information#

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

Directions

INDICATIONS & USAGE SECTION

Adults and children 12 years of age and older: apply at least a 1-inch strip of product onto a soft bristle toothbrush

  • brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 tims a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimiza swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.

Uses

OTC - PURPOSE SECTION

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

WARNINGS SECTION

When using this product, if irritation occurs discontinue use.

OTC - STOP USE SECTION

Stop use and ask a dentist if

  • the problem persists or worsen
  • Sensitive teeth may indicate a resious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Active ingredients / Purpose

OTC - ACTIVE INGREDIENT SECTION

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

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older: 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5280184 Topcare Sensitive Mint fresh 2821184R4-OL5280184 Topcare Sensitive Mint fresh 2821184R4-OL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN3
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD3
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/48zr8h5820184 Topcare Sensitive Mint Fresh 2821184R4-OL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-364-10Topco Associates LLCMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE13
36800-364-10Topco Associates LLCMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1133

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-36436800-364-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM HYDROXIDE55X04QC32IIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SUCRALOSE96K6UQ3ZD4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-08-08full-release2026-06-01 01:09:45

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLC387d264c-90cc-5e67-e063-6394a90a713d2026-01-08WarningsExact identifier
ndc (package): 36800-364-10
ndc (product): 36800-364
ndc11 (package): 36800036410
spl id: 47e514c6-af35-cdd8-e063-6394a90aea44
spl set id: 387d264c-90cc-5e67-e063-6394a90a713d

Reported adverse events (FAERS/openFDA)#

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