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.
Mini Duo
- Manufacturer
- Smiletwice, Inc.
- Effective date
- 2023-12-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:05:11
Label at a glance#
ProductMini Duo
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure8 sections
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
Potassium Nitrate 5% Sodium Fluoride 0.240% (0.15% w/v fluoride ion)
Purpose
Antihypersensitivity
Anticavity
Uses
- Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
- Aids in prevention of dental cavities.
Warnings
When using this product,
if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Stop use and ask a dentist
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.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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
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.
Package Labeling: KIT 72164-102-23
Package Labeling: 72164-001-01
Package Labeling: 72164-000-02
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 3 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 3 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 3 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 3 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 3 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 3 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 3 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72164-102-23 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6d4a-d83d-e063-dadaa90ab31f | Mini Toothpaste-Duo KIT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72164-000-02 | Mini Duo | 23 g in 1 TUBE | PASTE | 23 g | 50 mg in 1g | 3 |
| 72164-001-02 | Mini Duo | 23 g in 1 TUBE | PASTE | 23 g | 50 mg in 1g | 3 |
| 72164-102-23 | Mini Duo | 1 in 1 KIT | KIT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72164-000 | MINI DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.] | 3 | Legacy NDC | 20231221_99509d36-cae4-43a7-9ae7-74c101b1bee9.zip |
| 72164-001 | MINI DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.] | 3 | Legacy NDC | 20231221_99509d36-cae4-43a7-9ae7-74c101b1bee9.zip |
| 72164-102 | MINI DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.] | 3 | Legacy NDC, 3 package rows | 20231221_99509d36-cae4-43a7-9ae7-74c101b1bee9.zip |
Products#
Every source-derived product name is available through these pages.
- Mini Duo
- POTASSIUM NITRATE, SODIUM FLUORIDE
- Early Bird Wintergreen and Peppermint
- WATER
- HYDRATED SILICA
- SORBITOL
- GLYCERIN
- SODIUM TRIPOLYPHOSPHATE ANHYDROUS
- COCAMIDOPROPYL BETAINE
- METHYL SALICYLATE
- SODIUM ASCORBYL PHOSPHATE
- VITAMIN A PALMITATE
- TOCOPHEROL
- ALOE VERA LEAF
- XYLITOL
- SACCHARIN SODIUM
- SUCRALOSE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- TITANIUM DIOXIDE
- SODIUM BENZOATE
- CITRIC ACID MONOHYDRATE
- POTASSIUM NITRATE
- NITRATE ION
- SODIUM FLUORIDE
- FLUORIDE ION
- Twilight Peppermint with Vanilla and Lavender
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72164-102 | 72164-102-23 |
| 72164-001 | 72164-001-02 |
| 72164-000 | 72164-000-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0d0042ce-c0b8-bd55-e063-6294a90a6bec | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 2023-12-21 | Warnings | 0d0042ce-c0b8-bd55-e063-6294a90a6bec 99509d36-cae4-43a7-9ae7-74c101b1bee9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.