{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Anticavity fluoride rinse Sodium fluoride WATER GLYCERIN SODIUM BENZOATE POTASSIUM SORBATE XYLITOL CITRIC ACID MONOHYDRATE SUCRALOSE SODIUM CITRATE, UNSPECIFIED FORM SODIUM FLUORIDE FLUORIDE ION"
      ],
      "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": [
        "Warning 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"
      ],
      "questions": [
        "Questions or comments? 1-888-423-0139"
      ],
      "other_safety_information": [
        "TAMPER EVIDENT STATEMENT SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION"
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO VIJA0624 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED"
      ],
      "spl_unclassified_section": [
        "Disclaimer *This product is not manufactured or distributed by Dr. Harold Katz, LLC., distributor of TheraBreath ® for Kids! Oral Rinse"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL COMPARE TO THERABREATH ® FOR KIDS! ORAL RINSE* TopCare ® everyday Kids Anticavity Fluoride Oral Rinse Watermelon Flavored Helps prevent cavites & strengthens teeth Dye, Paraben, Alcohol, and Sugar Free IMPORTANT: read directions for proper use. 10 FL OZ (296 mL) image description"
      ],
      "set_id": "c3f2e952-a8d5-4e9d-a5c6-09e4f2544179",
      "id": "4ab9cdfd-2e94-8a3c-e063-6394a90ac07a",
      "effective_time": "20260213",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity fluoride rinse"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Topco Associates LLC"
        ],
        "product_ndc": [
          "76162-838"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "4ab9cdfd-2e94-8a3c-e063-6394a90ac07a"
        ],
        "spl_set_id": [
          "c3f2e952-a8d5-4e9d-a5c6-09e4f2544179"
        ],
        "package_ndc": [
          "76162-838-38"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}