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.
Sensodyne
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-03-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:21
Label at a glance#
ProductSensodyne Natural white
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections
Dosage and administration
adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years: Consult a dent...
Storage and handling
do not store above 25°C (77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Purposes
Antihypersensitivity
Anticavity
Uses
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
- aids in the prevention of dental cavities.
Warnings
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.
- pain/sensitivity still persists after 4 weeks of use.
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 a 1-inch strip of the product onto a soft bristle toothbrush.
- brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years:Consult a dentist or doctor.
Other information
- do not store above 25°C (77°F)
Inactive ingredients
water, sorbitol, hydrated silica, glycerin, charcoal powder, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, sodium hydroxide, sucralose
Questions or comments?
1-866-844-2797
Additional Information
ALWAYS FOLLOW THE LABEL
What are sensitive teeth?
Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks.
What does Sensodyne do?
Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.
The active ingredient in Sensodyne is clinically proven to deliver 24/7 sensitivity protection*
Also contains:
Coconut derived charcoal to help restore teeth to their natural whiteness
Use Sensodyne Natural White twice daily:
- Long-lasting sensitivity protection*
- Contains fluoride to protect against cavities
- Helps remove stains for whiter teeth
- Freshens breath
*with twice daily brushing
Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
Principal Display Panel
NDC 0135-5028-01
new
#1 DENTIST RECOMMENDED BRAND
SENSODYNE
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
24/7 Sensitivity Protection* + Strong & Healthy Teeth
Natural White
with coconut derived charcoal
NET WT 4.0 OZ (113 g)
1001361 Carton Front
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086243 | potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste | PSN | 3 |
| 1086243 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste | SCD | 3 |
| 1086243 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 3 |
| 1086243 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 3 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0135-5028-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-698c-111a-e063-dadaa90a10e2 | Drug Facts |
| 0135-5028-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-698c-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-5028-01 | SensodyneNatural white | 1 in 1 CARTON | PASTE | 1 | 3 | |
| 0135-5028-01 | SensodyneNatural white | 113 g in 1 TUBE | PASTE | 113 | 3 | |
| 0135-5028-02 | SensodyneNatural white | 1 in 1 CARTON | PASTE | 1 | 3 | |
| 0135-5028-02 | SensodyneNatural white | 77 g in 1 TUBE | PASTE | 77 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sensodyne Natural white
- potassium nitrate and sodium fluoride
- WATER
- SORBITOL
- HYDRATED SILICA
- GLYCERIN
- ACTIVATED CHARCOAL
- COCAMIDOPROPYL BETAINE
- XANTHAN GUM
- SACCHARIN SODIUM
- SODIUM HYDROXIDE
- SUCRALOSE
- POTASSIUM NITRATE
- NITRATE ION
- SODIUM FLUORIDE
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0135-5028 | 0135-5028-01, 0135-5028-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ACTIVATED CHARCOAL | 2P3VWU3H10 | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POTASSIUM NITRATE | RU45X2JN0Z | ACTIB |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
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 |
|---|---|---|---|---|---|---|
| Sensodyne Natural white | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 911ac7e4-2b92-43d5-af0b-b5f741b088fb | 2024-03-04 | Warnings | 0135-5028-02 0135-5028-01 0135-5028 00135502801 00135502802 12d9a4c3-8aa2-f2c4-e063-6294a90a405c 911ac7e4-2b92-43d5-af0b-b5f741b088fb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.