Potassium Nitrate
Active ingredient
Sold as sensodyne · Trader Joes · Pronamel Repair Whitening · Sodium Fluoride 5000 ppm… · HAPEE EXPLOSIVE MENTHOL…
- Drug class
- -
- Availability
- Prescription and OTC
- Routes
- Dental, Oral
- Markets covered
- 2
- Products on record
- 10
- FDA reports (12 mo)
- 55
Overview
Plain-language summary, compiled from the cited regulatory records
Potassium nitrate is used in toothpaste formulations as a dental caries preventive and for managing tooth sensitivity [1]. It is approved for twice-daily topical use in adults and children 12 years of age and older. When used as directed, it helps reduce pain from cold, heat, acid, sweets, or contact [1].
This active ingredient is available under various brand names, including Sensodyne and Pronamel Repair Whitening [1]. In the past 12 months, there have been 55 adverse event reports associated with products containing potassium nitrate [2]. Commonly reported adverse events include fatigue, arthralgia, diarrhea, nausea, and reports of the drug being ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 9 | May 22, 2026 |
| GB United Kingdom | MHRA | 1 | January 9, 2026 |
USUnited States· FDA
9 products
Uses
INDICATIONS AND USAGE:
A dental caries preventive and sensitive toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adults patients and children 12 years of age and older.
1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush.
This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis.
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GBUnited Kingdom· MHRA
1 product
Uses
Used for removing granulation tissue, warts (including verrucae), for cautery and as a caustic.
How to take
Sources & citations
- [1]FDA DailyMed · 02f4cf0b-188c-45… · revised April 1, 2020 [PDF]
- [2]MHRA (UK) · PL042860005 · revised January 9, 2026
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.