FDA.reportPublic FDA data

The Duo

Manufacturer
Smiletwice, Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:05:05

Label at a glance#

ProductThe Duo
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure12 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, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all 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

Antihypersensitivity

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, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all 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, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Ascorbyl Phosphate (Vitamin C), 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.

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5% Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity

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, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all 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, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Acorbyl Phosphate (Vitamin C), 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.

Twilight Peppermint with Vanilla and Lavender Toothpaste, 96g (72164-000-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Early Bird Wintergreen and Peppermint Toothpaste 96g (72164-001-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN6
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD6
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY6
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72164-100-022025-01-30C16284748780-12cef2736-a5d5-d83d-e063-dadaa90ab31fThe Duo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72164-000-01The Duo96 g in 1 TUBEPASTE96 g50 mg in 1g6
72164-001-01The Duo96 g in 1 TUBEPASTE96 g50 mg in 1g6
72164-100-02The Duo1 in 1 KITKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72164-000THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip
72164-001THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip
72164-100THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC, 3 package rows20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72164-10072164-100-02
72164-00072164-000-01
72164-00172164-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A PALMITATE1D1K0N0VVCIACT
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT
XYLITOLVCQ006KQ1EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT
XYLITOLVCQ006KQ1EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
0d0042ce-c0e1-bd55-e063-6294a90a6bec4c10df9f-cc42-41ba-968e-0f4470536e3d2023-12-21WarningsExact identifier
spl id: 0d0042ce-c0e1-bd55-e063-6294a90a6bec
spl set id: 4c10df9f-cc42-41ba-968e-0f4470536e3d

Reported adverse events (FAERS/openFDA)#

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