{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Floriva CHOLECALCIFEROL and SODIUM FLUORIDE CHOLECALCIFEROL CHOLECALCIFEROL SODIUM FLUORIDE FLUORIDE ION GLYCERIN WATER POLYSORBATE 80 SODIUM HYDROXIDE PROPYLENE GLYCOL SUCRALOSE METHYLPARABEN PROPYLPARABEN"
      ],
      "description": [
        "Supplement Facts Serving Size: 1 mL Servings Per Container: 50 Amount per serving % Daily Value Percent Daily Value (%DV) based on a 2000 calorie diet. Vitamin D 400 IU 100% Fluoride (sodium fluoride) 0.25 mg Daily Value not established. Other Ingredients: Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color and propyl paraben."
      ],
      "description_table": [
        "<table width=\"65%\"><col width=\"60%\" align=\"left\" valign=\"middle\"/><col width=\"20%\" align=\"right\" valign=\"middle\"/><col width=\"20%\" align=\"right\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\" colspan=\"3\">Supplement Facts</th></tr><tr><th styleCode=\"Lrule Rrule\" colspan=\"3\">Serving Size: 1 mL</th></tr><tr styleCode=\"Botrule\"><th styleCode=\"Lrule Rrule\" colspan=\"3\">Servings Per Container: 50</th></tr><tr><th styleCode=\"Lrule\"/><th>Amount per serving</th><th styleCode=\"Rrule\">% Daily Value<footnote>Percent Daily Value (%DV) based on a 2000 calorie diet.</footnote></th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Vitamin D</td><td>400 IU</td><td styleCode=\"Rrule\">100%</td></tr><tr><td styleCode=\"Lrule\">Fluoride (sodium fluoride)</td><td>0.25 mg</td><td styleCode=\"Rrule\"><footnote>Daily Value not established.</footnote></td></tr></tbody></table>"
      ],
      "warnings": [
        "WARNING KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. SHAKE WELL BEFORE USE"
      ],
      "dosage_and_administration": [
        "Directions Use as directed by a physician"
      ],
      "indications_and_usage": [
        "How to Use Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper. Do not accept if tamper evident box seal is broken or missing. The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner."
      ],
      "spl_unclassified_section": [
        "Caution Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives) since these may decrease effectiveness. Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.",
        "OTHER INFORMATION You may report serious side effects to 1-844-640-7607.",
        "The numeric identifer on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance, and state level reimbursement programs and is not intended to denote registration with the FDA. Manufactured for: BonGeo Pharmaceuticals, Inc. Roseland, NJ 07068 Manufactured by: Sancilio & Co., Inc. Riviera Beach, FL 33404 LOT/EXP"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label 52796-172-50 BonGeo ™ PHARMACEUTICALS Floriva ™ 0.25 mg DROPS 0.25 mg* FLUORIDE DROPS Fluoride and Vitamin D Liquid Drops Fruit Flavor Rx Dietary Supplement 1 2/3 FL. OZ (50 mL) SUGAR, SACCHARIN AND GLUTEN FREE NO ARTIFICIAL COLORS OR DYES *contains 0.25 mg fluoride from 0.55 mg sodium fluoride PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label"
      ],
      "set_id": "54eeeeda-9314-4b7c-9efc-0bedfffb91b6",
      "id": "b70f7032-674d-4052-84d9-35ee99f33868",
      "effective_time": "20240201",
      "version": "4",
      "openfda": {
        "brand_name": [
          "Floriva"
        ],
        "generic_name": [
          "CHOLECALCIFEROL AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "BonGeo Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "52796-172"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHOLECALCIFEROL",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1596005"
        ],
        "spl_id": [
          "b70f7032-674d-4052-84d9-35ee99f33868"
        ],
        "spl_set_id": [
          "54eeeeda-9314-4b7c-9efc-0bedfffb91b6"
        ],
        "package_ndc": [
          "52796-172-50"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0022797",
          "N0000175952"
        ],
        "pharm_class_cs": [
          "Vitamin D [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin D [EPC]"
        ],
        "unii": [
          "1C6V77QF41",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}