{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Ortho Super Chocolate Fluoride Mouthwash Anticavity Mouthwash SODIUM FLUORIDE FLUORIDE ION WATER ERYTHRITOL XYLITOL TRIBASIC CALCIUM PHOSPHATE MENAQUINONE 7 CHOLECALCIFEROL INULIN GLYCERIN SODIUM GLUCONATE SODIUM BICARBONATE DIMETHYL SULFONE BENZOIC ACID SODIUM ASCORBATE XANTHAN GUM"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT (in each 10 mL) Sodium Fluoride 0.02%"
      ],
      "purpose": [
        "PURPOSE Sodium Fluoride …. Anticavity"
      ],
      "indications_and_usage": [
        "USE Fluoride mouthwash"
      ],
      "warnings": [
        "WARNINGS: Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if safety seal is broken."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if safety seal is broken."
      ],
      "other_safety_information": [
        "If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if safety seal is broken."
      ],
      "dosage_and_administration": [
        "DIRECTIONS 1) Shake well before using. 2) Use daily by dispensing 10 mL, swish vigorously for 1 minute, and then spit out. 3) No need to rinse."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Water, Erythritol, Xylitol, *Hydroxamin+ ® (Nano-Hydroxyapatite, Menaquinone-7 (Vit K2), Cholecalciferol (Vit D3)), Inulin, Glycerin, Sodium Gluconate, Sodium Bicarbonate, Methylsulfonylmethane, Natural Flavors, Natural Benzoic Acid,Sodium Ascorbate (Vit C), Xanthan Gum."
      ],
      "package_label_principal_display_panel": [
        "Product Labeling: Ortho Super Chocolate Fluoride Mouthwash Supermouth super chocolate fluoride mouthwash with hydroxamin+ ® unique formulation for orthodontics that reaches areas brushing & flossing don’t 16 fl oz (473 mL) SuperMouth ® 9737 Aero Drive San Diego, CA 92123 (844) MOUTHCARE res Ortho Choc Floro 111"
      ],
      "set_id": "04e8df30-42a8-440f-8ca9-77b5982a3730",
      "id": "571e7f3d-a791-4fb9-a3fb-2a4df4c8b4ee",
      "effective_time": "20250220",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Ortho Super Chocolate Fluoride Mouthwash"
        ],
        "generic_name": [
          "ANTICAVITY MOUTHWASH"
        ],
        "manufacturer_name": [
          "SuperMouth, LLC."
        ],
        "product_ndc": [
          "83729-111"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "571e7f3d-a791-4fb9-a3fb-2a4df4c8b4ee"
        ],
        "spl_set_id": [
          "04e8df30-42a8-440f-8ca9-77b5982a3730"
        ],
        "package_ndc": [
          "83729-111-16"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}