{
  "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": [
        "Frida Fluoride Watermelon Sodium fluoride SORBITOL WATER HYDRATED SILICA XYLITOL BUTYLENE GLYCOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED EDETATE DISODIUM MICA POLYETHYLENE GLYCOL 1600 PHENOXYETHANOL POTASSIUM SORBATE SODIUM CITRATE, UNSPECIFIED FORM SODIUM LAUROYL SARCOSINATE STEVIA LEAF WATERMELON TITANIUM DIOXIDE .ALPHA.-TOCOPHEROL ACETATE SODIUM FLUORIDE FLUORIDE ION Watermelon"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Sodium fluoride 0.22% (0.13% w/v fluoride ion)"
      ],
      "purpose": [
        "PURPOSE Anticavity"
      ],
      "indications_and_usage": [
        "USES Aids in the prevention of dental cavities."
      ],
      "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 Keep out of 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 meals or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS sorbitol, water, hydrated silica, xylitol, butylene glycol, cellulose gum, disodium EDTA, flavor, mica, PEG-32, phenoxyethanol, potassium sorbate, sodium citrate, sodium lauroyl sarcosinate, stevia leaf extract, watermelon (citrullus lanatus) fruit extract, titanium dioxide, tocopheryl acetate"
      ],
      "spl_unclassified_section": [
        "ADDITIONAL LABELING INFORMATION Questions? 1-833-983-3743 Ages 2+; Fluoride strengthens enamel to help prevent cavities; Removes plaque for cleaner, healthier teeth; NET WT 4 OZ / 113 g. Manufactured for Fridababy LLC, Miami, FL 33137. Made in Malaysia."
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton Principal display panel / package label image - Carton Labeling image MM1",
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Tube Principal display panel / package label image - Tube Labeling image MM2"
      ],
      "set_id": "4f8b49dc-e9e4-c341-e063-6294a90adb5a",
      "id": "5118a0a4-728f-6884-e063-6394a90a02b3",
      "effective_time": "20260505",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Frida Fluoride Watermelon"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Fridababy, LLC"
        ],
        "product_ndc": [
          "72705-501"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "245598"
        ],
        "spl_id": [
          "5118a0a4-728f-6884-e063-6394a90a02b3"
        ],
        "spl_set_id": [
          "4f8b49dc-e9e4-c341-e063-6294a90adb5a"
        ],
        "package_ndc": [
          "72705-501-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0810028778757"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}