{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Anticavity fluoride rinse Sodium fluoride GLYCERIN SODIUM BENZOATE WATER POTASSIUM SORBATE XYLITOL CITRIC ACID MONOHYDRATE SUCRALOSE SODIUM CITRATE, UNSPECIFIED FORM SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "TAMPER EVIDENT STATEMENT SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION",
        "Disclaimer *This product is not manufactured or distributed by Church & Dwight Co. Inc., distributor of TheraBreath ® for Kids! Anticavity Fluoride Oral Rinse Wacky Watermelon."
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings For this product"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor"
      ],
      "storage_and_handling": [
        "Other information store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate"
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction Questions 1-888-593-0593 DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC 79481-0838-1 meijer ® COMPARE TO THERABREATH ® FOR KIDS! WACKY WATERMELON* Kids Anticavity Fluoride Oral Rinse Wonderful Watermelon Strong Cavity Protection Dye, Alcohol & Sugar Free Helps Strengthen Teeth IMPORTANT: read directions for proper use. 10 FL OZ (296 mL) image description"
      ],
      "set_id": "0bb9fb5f-1893-4187-b60b-05319a8fac6a",
      "id": "4b3480bd-bd55-1325-e063-6394a90ad76c",
      "effective_time": "20260219",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity fluoride rinse"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Meijer, Inc."
        ],
        "product_ndc": [
          "79481-0838"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "4b3480bd-bd55-1325-e063-6394a90ad76c"
        ],
        "spl_set_id": [
          "0bb9fb5f-1893-4187-b60b-05319a8fac6a"
        ],
        "package_ndc": [
          "79481-0838-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0719283539199"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}