{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "brand_name": [
          "PREVIDENT"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Colgate Oral Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0126-0016"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "392038",
          "630194"
        ],
        "spl_id": [
          "f4c2f476-bdd5-49d1-80f7-361be61e47e5"
        ],
        "spl_set_id": [
          "d93ee76f-454b-40bf-9357-39a2ae3b6ccb"
        ],
        "package_ndc": [
          "0126-0016-61",
          "3834110622"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301260016610"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76516",
      "recalling_firm": "Colgate Palmolive Co",
      "address_1": "300 Park Ave",
      "address_2": "Attn: Anthony Cavaliere",
      "postal_code": "10022-7402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0521-2017",
      "product_description": "PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622",
      "product_quantity": "14,656 bottles",
      "reason_for_recall": "Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.",
      "recall_initiation_date": "20170213",
      "center_classification_date": "20170315",
      "termination_date": "20170613",
      "report_date": "20170322",
      "code_info": "Lots:  6350US561G, 6350US562G, 6351US561G, 6351US562G"
    }
  ]
}