{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Sensodyne Pronamel Kids Bubble Mint sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.245% (0.15% 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 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, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. children under 2 years of age: Consult a dentist or doctor."
      ],
      "spl_unclassified_section": [
        "Other information do not store above 25°C (77°F)",
        "Additional Information ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Bubble Mint KiDS #1 DENTIST RECOMMENDED TOOTHPASTE FOR PROTECTING AND STRENGTHENING ENAMEL Adults | Kids Kids enamel is 50% thinner Kids enamel is 50% thinner vs an Adults This makes kids’ teeth more vulnerable to everyday sugar & dietary acids like fruit and juices. 24hr Cavity Protection* 2x Stronger Enamel Defense** Pronamel Kids strengthens and protects developing enamel. Strong enamel is the best defense against cavities and enamel wear. Pronamel for Kids provides: 24 hour Cavity Protection* 2x Stronger Enamel Defense** Natural Flavors Gluten Free Vegan Friendly*** Sugar, SLS & Paraben Free *Follow a healthy diet and brush twice daily. (Level of protection may decrease between brushing.) **Protection from sugar acids vs your mouth’s natural defenses. ***Contains no animal products and animal derived products."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, blue 1"
      ],
      "questions": [
        "Questions or comments? 1-866-844-2797"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel new look SENSODYNE PRONAMEL KiDS Bubble Mint FLUORIDE ANTICAVITY TOOTHPASTE 24hr Cavity Protection* 2X Stronger Enamel Defense** NET WT 4.0 OZ (113 g) Sensodyne Pronamel Kids Bubble Mint 4 oz"
      ],
      "set_id": "41b1e626-e79b-d638-e063-6394a90a1f5b",
      "id": "4394cf17-0793-a5c9-e063-6294a90a73c0",
      "effective_time": "20251215",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Sensodyne Pronamel Kids Bubble Mint"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0818"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "4394cf17-0793-a5c9-e063-6294a90a73c0"
        ],
        "spl_set_id": [
          "41b1e626-e79b-d638-e063-6394a90a1f5b"
        ],
        "package_ndc": [
          "0135-0818-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}