{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "SprinJene Natural Sensitivity Relief Sodium Monofluorophosphate and Potassium Nitrate Sodium Monofluorophosphate Fluoride Ion Potassium Nitrate NITRATE ION Water Glycerin Calcium Carbonate Silicon Dioxide Propanediol Potassium Cocoate Zinc Citrate Xanthan Gum Acacia Zinc Oxide CITRIC ACID MONOHYDRATE STEVIA REBAUDIUNA LEAF"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Manufactured and Dist. by Health and Natural Beauty USA Corp. Piscataway, NJ 08854"
      ],
      "active_ingredient": [
        "Active Ingredient Purpose Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion) Anticavity Potassium Nitrate: 5% Antihypersensitivity"
      ],
      "active_ingredient_table": [
        "<table width=\"70%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"bottom\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredient</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion)</td><td>Anticavity</td></tr><tr><td>Potassium Nitrate: 5%</td><td>Antihypersensitivity</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active Ingredient Purpose Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion) Anticavity Potassium Nitrate: 5% Antihypersensitivity"
      ],
      "purpose_table": [
        "<table width=\"70%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"bottom\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredient</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion)</td><td>Anticavity</td></tr><tr><td>Potassium Nitrate: 5%</td><td>Antihypersensitivity</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Use Helps remove surface stains with regular brushing, and helps prevent plaque buildup."
      ],
      "warnings": [
        "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Supervise children as necessary until capable of using without supervision. Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Xylitol, Aqua, Glycerin, Precipitated Natural Calcium Carbonate, Hydrated Silica, Zemea (1,3-Propanediol made from Corn), Potassium Cocoate (made from Coconut Oil), Flavor, Zinc Citrate, Xanthan Gum, Acacia Gum, Zinc Oxide, Black Seed Oil (Nigella sativa), Citric Acid, Stevia"
      ],
      "questions": [
        "Questions or comments? Call 1-844-346-2872 www.sprinjene.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 99 g Tube Carton SprinJene ® + Sensitivity Natural Relief CAVITY PROTECTION TOOTHPASTE with Black Seed Oil (Nigella sativa) & Zinc Helps Relieve Teeth Sensitivity | Remineralizes Enamel Helps Dry Mouth | Cleans Teeth | Freshens Breath NET WT 3.5 OZ (99 g) Made in USA To accommodate the needs of various lifestyles. CERTIFIED VEGAN V VEGAN.ORG Vegan GLUTEN-FREE ICS CERTIFIED Gluten Free U Kosher HALAL Halal Certified PRINCIPAL DISPLAY PANEL - 99 g Tube Carton"
      ],
      "set_id": "32cc5bc2-60c9-4cb4-acde-485ae494aba2",
      "id": "8b20c8a1-ffe1-4f07-b783-b206720640c2",
      "effective_time": "20260814",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "SprinJene Natural Sensitivity Relief"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE"
        ],
        "manufacturer_name": [
          "Health and Natural Beauty USA Corp"
        ],
        "product_ndc": [
          "63404-1942"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE",
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "1038800"
        ],
        "spl_id": [
          "8b20c8a1-ffe1-4f07-b783-b206720640c2"
        ],
        "spl_set_id": [
          "32cc5bc2-60c9-4cb4-acde-485ae494aba2"
        ],
        "package_ndc": [
          "63404-1942-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q",
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}