{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hello Unicorn Splash sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS POTASSIUM CITRATE XYLITOL POLOXAMER 407 PHOSPHORIC ACID"
      ],
      "description": [
        "Hello Unicorn Splash unicorn splash anticavity fluoride rinse",
        "Drug Facts"
      ],
      "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 Keep out of reach of children. If more than used for rinsing 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. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Vigorously swith 10 mL (2 teaspoons) 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). Surpervise children as necessary until capable of using without supervision. Children under 6 years of age: consult dentist or doctor."
      ],
      "other_safety_information": [
        "Other information Store at room temperature Do not use if printed band around cap is broken or missing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid."
      ],
      "questions": [
        "Questions? 1-855-444-3556 Dist. by Hello Products LLC Montclair, NJ 07042"
      ],
      "spl_unclassified_section": [
        ""
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 520 mL Bottle Label hello unicorn splash anticavity fluoride rinse bubble gum natural flavor prevents cavities • no alcohol strengthens teeth 17.6 FL OZ (1.1 PT) 520 mL PS0086273 IMPORTANT: Read directions for proper use. label"
      ],
      "set_id": "23807810-990a-b723-e063-6394a90aee3e",
      "id": "48fd0b79-d03d-113f-e063-6294a90a7e7f",
      "effective_time": "20260122",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Hello Unicorn Splash"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Accupac LLC"
        ],
        "product_ndc": [
          "44038-0687"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "48fd0b79-d03d-113f-e063-6294a90a7e7f"
        ],
        "spl_set_id": [
          "23807810-990a-b723-e063-6394a90aee3e"
        ],
        "package_ndc": [
          "44038-0687-1",
          "44038-0687-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}