{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 32
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sensitivity and Gum with Cavity Protection Potassium Nitrate and Sodium Fluoride Potassium Nitrate Nitrate ion Sodium Fluoride fluoride ion Water Xylitol GLYCERIN Hydrated silica PROPANEDIOL ACACIA XANTHAN GUM Zinc Citrate COCAMIDOPROPYL HYDROXYSULTAINE Sodium Hydroxide COCONUT OIL GINGER OIL GOLDENSEAL TEA TREE OIL HIPPOPHAE RHAMNOIDES FRUIT OIL POMEGRANATE SEED OIL"
      ],
      "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=\"50%\" styleCode=\"Noautorules\"><col width=\"76%\" align=\"left\" valign=\"top\"/><col width=\"24%\" align=\"right\" valign=\"top\"/><thead><tr><th>ACTIVE INGREDIENT</th><th align=\"left\">PURPOSE</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=\"50%\" styleCode=\"Noautorules\"><col width=\"76%\" align=\"left\" valign=\"top\"/><col width=\"24%\" align=\"right\" valign=\"top\"/><thead><tr><th>ACTIVE INGREDIENT</th><th align=\"left\">PURPOSE</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 1) Aids in prevention of cavities. 2) Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact."
      ],
      "warnings": [
        "WARNINGS Keep out of reach of children. \"Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.\""
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. \"Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.\""
      ],
      "dosage_and_administration": [
        "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) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Water (Aqua), Glycerin, Hydrated Silica, Xylitol, 1,3 - Propanediol (Zemea - made from non-GMO Corn), Natural Peppermint Oil, Cocamidopropyl Hydroxysultaine (from Coconut Oil), Zinc Citrate, Xanthan Gum, Nigella Sativa (Black Seed Oil), Sodium Hydroxide, TiO2, Stevia Rebaudiana Extract, Acacia Gum, Echinacea Purpurea (Coneflower Extract), Commiphora Myrrha (Myrrh Oil), Rosmarinus Officinalis (Rosemary Oil), Thymus Vulgaris Oil (Thyme ), Eugenia Caryophyllus (Clove Bud Oil), Cocos Nucifera (Coconut Oil), Zingiber Officinale (Ginger Oil), Hydrastis Canadensis (Goldenseal Root), Melaleuca Alternifolia (Tea Tree Oil), Hippophae Rhamnoides (Sea Buckthorn Fruit Oil), Punica Granatum (Pomegranate Seed Oil)"
      ],
      "questions": [
        "Questions or comments? Call 1-844-346-2872 www.sprinjene.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 142 g Tube Carton SprinJene Natural ® SENSITIVITY & GUM CAVITY PROTECTION TOOTHPASTE BURSTING WITH THE UNIQUE BENEFITS OF BLACK SEED OIL AND ZINC ✓ POMEGRANATE ✓ TEA TREE OIL ✓ THYME FREE FROM: SLS • DYE • PRESERVATIVES NATURAL PEPPERMINT OIL NET WT 5 OZ (142g) CERTIFIED: CERTIFIED VEGAN VEGAN.ORG VEGAN GLUTEN-FREE ICS CERTIFIED GLUTEN FREE USDA CERTIFIED BIOBASED PRODUCT PRODUCT 100% USDA BIOPREFERRED KOSHER CRUELTY FREE PRINCIPAL DISPLAY PANEL - 142 g Tube Carton"
      ],
      "set_id": "137d6935-19a3-499d-957c-820156eec7a5",
      "id": "8bccdcbd-ce36-40b0-a3e9-6c5d3c004242",
      "effective_time": "20260522",
      "version": "1",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Sensitivity and Gum with Cavity Protection"
        ],
        "generic_name": [
          "POTASSIUM NITRATE AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Health and Natural Beauty USA Corp"
        ],
        "product_ndc": [
          "63404-2210"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "8bccdcbd-ce36-40b0-a3e9-6c5d3c004242"
        ],
        "spl_set_id": [
          "137d6935-19a3-499d-957c-820156eec7a5"
        ],
        "package_ndc": [
          "63404-2210-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363404001265"
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}