{
  "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": [
        "AVON Whitening Essentials Original Cool Mint Sodium Fluoride HEXASODIUM HEXAMETAPHOSPHATE GLYCERIN WATER POLYETHYLENE GLYCOL 300 SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SODIUM LAURYL SULFATE CARRAGEENAN COCAMIDOPROPYL BETAINE SACCHARIN SODIUM SACCHARIN SUCRALOSE TITANIUM DIOXIDE HYDRATED SILICA XANTHAN GUM MICA CITRUS LIMON FRUIT OIL ACTIVATED CHARCOAL SODIUM CHLORIDE SODIUM FLUORIDE FLUORIDE ION Cool"
      ],
      "spl_unclassified_section": [
        "Drug Facts Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium fluoride 0.243% (0.16% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use helps protect against cavities"
      ],
      "warnings": [
        "Warnings Warnings Keep out of reach of children. Keep out of reach of children under 6 years of age. Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If an allergic reaction develops, discontinue to use immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. Keep out of reach of children under 6 years of age. Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If an allergic reaction develops, discontinue to use immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years and older Brush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow. Children between 6 and 12 years To minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 6 years Ask a dentist or physician."
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children 6 years and older</td><td>Brush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow.</td></tr><tr><td>Children between 6 and 12 years</td><td>To minimize swallowing, use a pea-sized amount and supervise children&apos;s brushing and rinsing until good habits are established.</td></tr><tr><td>Children under 6 years</td><td>Ask a dentist or physician.</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica, charcoal powder, citrus limon(lemon) fruit extract, sodium chloride"
      ],
      "questions": [
        "1-800-FOR-AVON www.avon.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel - 156 g Tube Carton AVON Whitening Essentials FLUORIDE TOOTHPASTE CAVITY PROTECTION HELPS WHITEN TEETH - REMOVES SURFACE STAINS ORIGINAL COOL MINT NET WT 5.5 oz (156 g) COOLMINT"
      ],
      "set_id": "8e5de76b-535a-9c95-e053-2995a90afcab",
      "id": "2aabd54c-d9ab-e892-e063-6394a90a1d9e",
      "effective_time": "20250101",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "AVON Whitening Essentials Original Cool Mint"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Tai Guk Pharm. Co., Ltd."
        ],
        "product_ndc": [
          "43136-901"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "891775"
        ],
        "spl_id": [
          "2aabd54c-d9ab-e892-e063-6394a90a1d9e"
        ],
        "spl_set_id": [
          "8e5de76b-535a-9c95-e053-2995a90afcab"
        ],
        "package_ndc": [
          "43136-901-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0803954301052"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}