{
  "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": "2026-07-18",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ACT Anticavity Fluoride Kids Wild Watermelon sodium fluoride 0.24 (0.14 w/v fluoride ion) SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA SUCRALOSE BENZOIC ACID SACCHARIN SODIUM POTASSIUM HYDROXIDE SODIUM BENZOATE GLYCYRRHIZINATE DIPOTASSIUM SODIUM LAURYL SULFATE FD&C YELLOW NO. 5 FD&C GREEN NO. 3 HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)"
      ],
      "spl_unclassified_section": [
        "ACT Kids Anticavity Fluoride Toothpaste ( Wild Watermelon ) Drug Facts",
        "Other information ■ contains FD&C yellow no. 5 (tartrazine) as a color additive"
      ],
      "active_ingredient": [
        "Active i ngredient Sodium fluoride 0.24% (0.14% 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, or as directed by a dentist or doctor children 2 to 6 years of age instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision. children under 2 years of age do not use unless directed by a dentist or doctor"
      ],
      "dosage_and_administration_table": [
        "<table><col width=\"339\"/><col width=\"339\"/><tbody><tr><td styleCode=\"Toprule Rrule \">adults and children 2 years of age and older</td><td styleCode=\"Toprule Lrule \">brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor</td></tr><tr><td styleCode=\"Toprule Rrule \">children 2 to 6 years of age</td><td styleCode=\"Toprule Lrule \">instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.</td></tr><tr><td styleCode=\"Toprule Rrule \">children under 2 years of age</td><td styleCode=\"Toprule Lrule \">do not use unless directed by a dentist or doctor</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, yellow 5, green 3"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL ACT Kids wild water- melon NET WT 4.6 oz (130 g) PRINCIPAL DISPLAY PANEL ACT Kids wild water- melon NET WT 4.6 oz (130 g)"
      ],
      "set_id": "bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8",
      "id": "37336c01-148c-42b0-82b0-aaaf922e1fd1",
      "effective_time": "20260112",
      "version": "6",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "ACT Anticavity Fluoride Kids Wild Watermelon"
        ],
        "generic_name": [
          "SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)"
        ],
        "manufacturer_name": [
          "Chattem, Inc."
        ],
        "product_ndc": [
          "41167-0924"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "37336c01-148c-42b0-82b0-aaaf922e1fd1"
        ],
        "spl_set_id": [
          "bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8"
        ],
        "package_ndc": [
          "41167-0924-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}