Overview
Potassium nitrate is an inorganic salt with a chemical formula of KNO3. It is a natural source of nitrate and has been used as a constituent for several different purposes, including food preservatives, fertilizers, tree stump removal, rocket propellants, and fireworks. Potassium nitrate is a common active ingredient in toothpaste, exerting an anti-sensitivity action. It provides increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact . In addition, potassium nitrate is used as a diuretic in pigs, cattle, and horses. It is administered orally doses up to 30 g per animal per day .
Background
Potassium nitrate is an inorganic salt with a chemical formula of KNO3. It is a natural source of nitrate and has been used as a constituent for several different purposes, including food preservatives, fertilizers, tree stump removal, rocket propellants, and fireworks. Potassium nitrate is a common active ingredient in toothpaste, exerting an anti-sensitivity action. It provides increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact . In addition, potassium nitrate is used as a diuretic in pigs, cattle, and horses. It is administered orally doses up to 30 g per animal per day .
Indication
For the relief of tooth sensitivity, and is also used as a pesticide, insecticide, as a food additive, and a rodenticide .
Associated Conditions
- Sensitivity, Tooth
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/06/04 | Phase 2 | Recruiting | |||
2018/08/13 | Phase 2 | Completed | |||
2018/03/29 | Phase 2 | Completed | |||
2016/11/04 | Not Applicable | Completed | |||
2012/08/06 | Not Applicable | Completed | |||
2012/04/30 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fulijaya Manufacturing Sdn. Bhd | 62776-003 | DENTAL | 50 mg in 1 g | 6/23/2025 | |
| Colgate Oral Pharmaceuticals, Inc. | 0126-0070 | DENTAL | 57.5 mg in 1 mL | 12/9/2019 | |
| Westminster Pharmaceuticals, LLC | 69367-318 | DENTAL | 57.5 mg in 1 mL | 6/15/2022 | |
| The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-500 | ORAL | 5.0 g in 100 g | 9/25/2023 | |
| McKesson Medical-Surgical | 68599-6302 | TOPICAL | 75 mg in 1 g | 1/15/2021 | |
| PSS World Medical, Inc. | 68345-100 | TOPICAL | 25 mg in 1 1 | 10/26/2012 | |
| Dharma Research, Inc. | 53045-281 | DENTAL | 5 mg in 100 g | 8/2/2015 | |
| Sheffield Pharmaceuticals LLC | 11527-704 | DENTAL | 57.5 mg in 1 mL | 3/2/2020 | |
| Colgate Oral Pharmaceuticals, Inc. | 0126-0022 | DENTAL | 57.5 mg in 1 mL | 8/17/2022 | |
| Sheffield Pharmaceuticals LLC | 11527-745 | DENTAL | 57.5 mg in 1 mL | 1/7/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NEUTRAFLUOR 5000 SENSITIVE TOOTHPASTE bottle | 176745 | Medicine | A | 10/18/2010 | |
| Colgate Sensitive Advanced Clean Fluoride Toothpaste | 310283 | Medicine | A | 10/11/2018 | |
| Sensodyne Daily Care | 489705 | Medicine | A | 5/23/2025 | |
| Sensodyne Daily Care | 404150 | Medicine | A | 2/1/2023 | |
| SILVER NITRATE APPLICATORS | 33738 | Medicine | A | 12/12/1991 | |
| DENTITEX Sensitive Toothpaste plus Whitening | 289700 | Medicine | A | 6/5/2017 | |
| Sensodyne Daily Care + Whitening | 404152 | Medicine | A | 2/1/2023 | |
| Sensodyne Extra Fresh Complete Care+ Smart Clean | 384096 | Medicine | A | 2/16/2022 | |
| NEUTRAFLUOR 5000 SENSITIVE TOOTHPASTE bottle (reformulation) | 435310 | Medicine | A | 1/18/2024 | |
| LISTERINE TOTAL CARE SENSITIVE ANTISEPTIC MOUTHWASH bottle | 178257 | Medicine | A | 12/9/2010 |