{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Sensitivity Relief Fluoride Free Potassium Nitrate Potassium Nitrate Nitrate ion Water glycerin Xylitol Hydrated Silica Calcium carbonate PROPANEDIOL Xanthan Gum Zinc citrate COCAMIDOPROPYL HYDROXYSULTAINE Zinc Oxide Sodium Lauryl sulfoacetate Acacia"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS",
        "Manufactured & Dist. by Health and Natural Beauty USA Corp. Piscataway, NJ 08854"
      ],
      "active_ingredient": [
        "Active ingredient Potassium Nitrate 5%"
      ],
      "purpose": [
        "Purpose Antihypersensitivity"
      ],
      "indications_and_usage": [
        "Uses 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."
      ],
      "ask_doctor": [
        "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": [
        "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, Glycerin, Xylitol, Hydrated Silica, Calcium Carbonate, Zemea from Non-GMO Corn (1,3-Propanediol), Natural Peppermint Oil, Xanthan Gum, Cocamidopropyl Hydroxysultaine, Zinc Citrate, Zinc Oxide, Black Seed Oil (Nigella Sativa), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Acacia Gum"
      ],
      "questions": [
        "Questions or comments? Call 1-844-346-2872 www.sprinjene.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 100 g Tube Carton SprinJene ® +Sensitivity Natural Relief FLUORIDE FREE TOOTHPASTE with BLACK SEED OIL (Nigella sativa) & Zinc HELPS RELIEVE TEETH SENSITIVITY | FRESHENS BREATH HELPS DRY MOUTH | CLEANS TEETH NET WT 3.5 OZ (100 g) Made in USA To accommodate the needs of various lifestyles. USDA CERTIFIED BIOBASED PRODUCT PRODUCT 100% USDA BIOPREFERRED CERTIFIED VEGAN VEGAN.ORG VEGAN GLUTEN-FREE ICS CERTIFIED GLUTEN FREE KOSHER CRUELTY FREE Certified PRINCIPAL DISPLAY PANEL - 100 g Tube Carton"
      ],
      "set_id": "c23b2a83-ebc3-4bcf-a216-7693944dcfa0",
      "id": "8b7a44b8-4906-41dd-a8ec-a56eb779c899",
      "effective_time": "20260522",
      "version": "1",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Sensitivity Relief Fluoride Free"
        ],
        "generic_name": [
          "POTASSIUM NITRATE"
        ],
        "manufacturer_name": [
          "Health and Natural Beauty USA Corp"
        ],
        "product_ndc": [
          "63404-2105"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "312544"
        ],
        "spl_id": [
          "8b7a44b8-4906-41dd-a8ec-a56eb779c899"
        ],
        "spl_set_id": [
          "c23b2a83-ebc3-4bcf-a216-7693944dcfa0"
        ],
        "package_ndc": [
          "63404-2105-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363404000077"
        ],
        "unii": [
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}