{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20150416",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38617",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360Orig1s009lbl.pdf",
              "date": "20150421",
              "type": "Label"
            },
            {
              "id": "7292",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s009ltr.pdf",
              "date": "20150417",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20131028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17290",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s007lbl.pdf",
              "date": "20131107",
              "type": "Label"
            },
            {
              "id": "29644",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s007ltr.pdf",
              "date": "20131029",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20130308",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "48856",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022360Orig1S005.pdf",
              "date": "20170628",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20091221",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20241121",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "80274",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022360Orig1s018lbl.pdf",
              "date": "20241122",
              "type": "Label"
            },
            {
              "id": "80309",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022360Orig1s018ltr.pdf",
              "date": "20241122",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090518",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "7289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022360s000ltr.pdf",
              "date": "20090527",
              "type": "Letter"
            },
            {
              "id": "22001",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360_nicorette_toc.html",
              "date": "20091230",
              "type": "Review"
            },
            {
              "id": "24288",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360s000_SumR.pdf",
              "date": "20091230",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20210305",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "67798",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022360Orig1s012ltr.pdf",
              "date": "20210615",
              "type": "Letter"
            },
            {
              "id": "67816",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022360Orig1s012lbl.pdf",
              "date": "20210615",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20150930",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38618",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360s010lbl.pdf",
              "date": "20151022",
              "type": "Label"
            },
            {
              "id": "7293",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s010ltr.pdf",
              "date": "20151002",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20140214",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "22002",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022360Orig1s008.pdf",
              "date": "20151118",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20130523",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "7291",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s006ltr.pdf",
              "date": "20130528",
              "type": "Letter"
            },
            {
              "id": "17289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s006lbl.pdf",
              "date": "20130924",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20120918",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38616",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022360Orig1s004lbl.pdf",
              "date": "20130417",
              "type": "Label"
            },
            {
              "id": "7290",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022360Orig1s004ltr.pdf",
              "date": "20120924",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20250317",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "81631",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022360Orig1s019lbl.pdf",
              "date": "20250318",
              "type": "Label"
            },
            {
              "id": "81632",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022360Orig1s019ltr.pdf",
              "date": "20250318",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20111206",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "29643",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022360s002ltr.pdf",
              "date": "20111208",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20240430",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78335",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022360Orig1s017ltr.pdf",
              "date": "20240502",
              "type": "Letter"
            },
            {
              "id": "78345",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022360Orig1s017lbl.pdf",
              "date": "20240502",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20180605",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54551",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022360ORig1s011ltr.pdf",
              "date": "20180614",
              "type": "Letter"
            },
            {
              "id": "54652",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022360ORig1s011lbl.pdf",
              "date": "20180621",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA022360",
      "sponsor_name": "HALEON US HOLDINGS",
      "openfda": {
        "application_number": [
          "NDA022360"
        ],
        "brand_name": [
          "NICORETTE",
          "NICORETTE PEPPERMINT",
          "NICORETTE CHERRY PEPPERMINT"
        ],
        "generic_name": [
          "NICOTINE POLACRILEX"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-1500",
          "0135-2800",
          "0135-0508",
          "0135-0509",
          "0135-8050",
          "0135-8060",
          "0135-8070",
          "0135-8071"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NICOTINE"
        ],
        "rxcui": [
          "359817",
          "359818",
          "968849",
          "968851"
        ],
        "spl_id": [
          "7b5518a7-f738-4f58-9c16-f6092a3885a5",
          "12f1fec8-003a-8788-e063-6394a90a298a",
          "52061944-15dc-452a-8135-57033cc601ad",
          "3724f342-04db-e129-e063-6294a90a6c7d"
        ],
        "spl_set_id": [
          "c7f32ab1-f6bd-46f5-9852-8eb5b78a3326",
          "fdee1637-8049-4bc5-b196-b6d854c9f9f3",
          "990a4a65-d573-46a9-889d-60afb0018944",
          "35438b53-2760-bcfe-e063-6394a90a65c0"
        ],
        "package_ndc": [
          "0135-2800-01",
          "0135-2800-02",
          "0135-1500-01",
          "0135-1500-02",
          "0135-0508-02",
          "0135-0508-03",
          "0135-0508-04",
          "0135-0509-02",
          "0135-0509-03",
          "0135-0509-04",
          "0135-8050-20",
          "0135-8050-81",
          "0135-8060-20",
          "0135-8060-81",
          "0135-8070-20",
          "0135-8070-81",
          "0135-8071-20",
          "0135-8071-81"
        ],
        "nui": [
          "N0000175706",
          "M0014836"
        ],
        "pharm_class_epc": [
          "Cholinergic Nicotinic Agonist [EPC]"
        ],
        "pharm_class_cs": [
          "Nicotine [CS]"
        ],
        "unii": [
          "6M3C89ZY6R"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "NICORETTE",
          "active_ingredients": [
            {
              "name": "NICOTINE POLACRILEX",
              "strength": "EQ 2MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TROCHE/LOZENGE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "NICORETTE",
          "active_ingredients": [
            {
              "name": "NICOTINE POLACRILEX",
              "strength": "EQ 4MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TROCHE/LOZENGE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}