{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "HEB HEBuddy Fluoride MICA GLYCERIN WATER SODIUM BENZOATE SORBITOL TITANIUM DIOXIDE SACCHARIN SODIUM COCAMIDOPROPYL BETAINE HYDRATED SILICA POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM FD&C RED NO. 40 SODIUM FLUORIDE FLUORIDE ION Watermelon mint"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204 MADE IN USA"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.243%"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Helps protect against 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 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."
      ],
      "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. Do not swallow To minimize swallowing use a pea-sized amount in children under 6 Supervise childrens brushing until good habits are established Children under 2 years of age: consult a dentist or doctor."
      ],
      "storage_and_handling": [
        "Other information Store in a cool dry place. Keep tube capped when not in use."
      ],
      "inactive_ingredient": [
        "Inactive ingredients sorbitol, water, hydrated silica, glycerin, cellulose gum, PEG-12, flavor, sodium benzoate, sodium saccharin, cocamidopropyl betaine, mica, titanium dioxide, red 40"
      ],
      "questions": [
        "Questions? Call 1-877-777-2743"
      ],
      "package_label_principal_display_panel": [
        "Tube label"
      ],
      "set_id": "a6af1baf-17bf-428c-8744-1490359b0cfb",
      "id": "437f93d5-d593-6b3a-e063-6294a90ac268",
      "effective_time": "20251113",
      "version": "9",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "HEB HEBuddy"
        ],
        "generic_name": [
          "FLUORIDE"
        ],
        "manufacturer_name": [
          "HEB"
        ],
        "product_ndc": [
          "37808-192"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "891775"
        ],
        "spl_id": [
          "437f93d5-d593-6b3a-e063-6294a90ac268"
        ],
        "spl_set_id": [
          "a6af1baf-17bf-428c-8744-1490359b0cfb"
        ],
        "package_ndc": [
          "37808-192-00",
          "37808-192-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}