FDA.reportPublic FDA data

Spearmint Eucalyptus

Manufacturer
Smiletwice, Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:23

Label at a glance#

ProductSpearmint Eucalyptus
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure6 sections

Indications and uses

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

Dosage and administration

• Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly after meals or at least twice a day or as recommended by a dentist or doctor. Make sure to brush sensitive areas of the teeth. Minimize swallowing. • Children under 12 years: consult a dentist or doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%.

Sodium fluoride 0.240% (0.15% w/v fluoride ion).

Purpose

OTC - PURPOSE SECTION

Antisensitivity

Anticavity

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

  • if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop use and ask a dentist

OTC - STOP USE SECTION

if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly after meals or at least twice a day or as recommended by a dentist or doctor. Make sure to brush sensitive areas of the teeth. Minimize swallowing.

• Children under 12 years: consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

• Water, Hydrated Silica, Sorbitol, Glycerin (Vegetable), Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03Label03Label04Label04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72164-006-002025-01-30C16284748780-12cef2736-87b1-d83d-e063-dadaa90ab31fSpearmint Eucalyptus Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72164-006-00Spearmint Eucalyptus96 g in 1 TUBEPASTE, DENTIFRICE962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72164-006SPEARMINT EUCALYPTUS (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [SMILETWICE, INC.]2Legacy NDC, 1 package rows20231222_2e0698aa-369a-4a02-b648-82342cba9a10.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72164-00672164-006-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYL SALICYLATELAV5U5022YIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

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
0d0b8e90-2068-1c76-e063-6394a90af6682e0698aa-369a-4a02-b648-82342cba9a102023-12-21WarningsExact identifier
spl id: 0d0b8e90-2068-1c76-e063-6394a90af668
spl set id: 2e0698aa-369a-4a02-b648-82342cba9a10

Reported adverse events (FAERS/openFDA)#

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