{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Salivea Fluoride Toothpaste SORBITOL GLYCERIN CALCIUM PYROPHOSPHATE WATER HYDRATED SILICA XYLITOL SILICON DIOXIDE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) ISOCETETH-20 CARBOXYMETHYLCELLULOSE SODIUM MINT SODIUM BENZOATE LACTOPEROXIDASE BOVINE POTASSIUM THIOCYANATE GLUCOSE OXIDASE LYSOZYME LACTOFERRIN, BOVINE DEXTRANASE PENICILLIUM CALCIUM LACTATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Sodium Monofluorophosphate (0.14% w/v fluoride ion)"
      ],
      "purpose": [
        "PURPOSE Anticavity"
      ],
      "indications_and_usage": [
        "USES Aids in the prevention of dental cavities."
      ],
      "warnings": [
        "WARNINGS Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN Keep out of the reach of children under 6 years of age."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. To minimize swallowing for children under 6, use a pea-size amount and supervise brushing until good habits are established. Children under 2 years ask a dentist or physician."
      ],
      "storage_and_handling": [
        "OTHER INFORMATION Store at Room Temperature."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, Glucose Oxidase, Lysozyme, Lactoferrin, Dextranase, Calcium Lactate."
      ],
      "questions": [
        "QUESTIONS Questions? Comments? Call toll-free: 1-877-522-5333"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SALIVEA DRY MOUTH CARE TOOTHPASTE Soothing Mint with Xylitol & Calcium image of carton"
      ],
      "set_id": "6398ae96-dd38-44da-bc34-1d4d4c4a78ca",
      "id": "2b37e5f3-ae54-4993-e063-6394a90aff97",
      "effective_time": "20250108",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Salivea"
        ],
        "generic_name": [
          "FLUORIDE TOOTHPASTE"
        ],
        "manufacturer_name": [
          "Laclede, Inc."
        ],
        "product_ndc": [
          "54897-701"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "851054"
        ],
        "spl_id": [
          "2b37e5f3-ae54-4993-e063-6394a90aff97"
        ],
        "spl_set_id": [
          "6398ae96-dd38-44da-bc34-1d4d4c4a78ca"
        ],
        "package_ndc": [
          "54897-701-13"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}