{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20040827",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "25871",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20802s010ltr.pdf",
              "date": "20040831",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20030521",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13463",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf",
              "date": "20030608",
              "type": "Label"
            },
            {
              "id": "3395",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20802slr009ltr.pdf",
              "date": "20030608",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20020419",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20000426",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19990820",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20230417",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74021",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020802Orig1s043lbl.pdf",
              "date": "20230419",
              "type": "Label"
            },
            {
              "id": "74022",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020802Orig1s043ltr.pdf",
              "date": "20230419",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19981022",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20160128",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20100204",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25873",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020802s019ltr.pdf",
              "date": "20100217",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20190415",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58341",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020802Orig1s033ltr.pdf",
              "date": "20190416",
              "type": "Letter"
            },
            {
              "id": "58342",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802Orig1s033lbl.pdf",
              "date": "20190416",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20140730",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20171012",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50080",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020802Orig1s031ltr.pdf",
              "date": "20171018",
              "type": "Letter"
            },
            {
              "id": "50205",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020802s031lbl.pdf",
              "date": "20171027",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20070131",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25872",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020802s015ltr.pdf",
              "date": "20070212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20001010",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20211103",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69227",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020802Orig1s038ltr.pdf",
              "date": "20211104",
              "type": "Letter"
            },
            {
              "id": "69285",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020802Orig1s038lbl.pdf",
              "date": "20211109",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20000907",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19991007",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "3394",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20802s02ltr.pdf",
              "date": "19991007",
              "type": "Letter"
            },
            {
              "id": "41712",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-802s002_Excedrin.html",
              "date": "19991007",
              "type": "Review"
            },
            {
              "id": "35388",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20802s02lbl.pdf",
              "date": "19991007",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20160429",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "42",
          "submission_status": "AP",
          "submission_status_date": "20230515",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "74267",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020802Orig1s042lbl.pdf",
              "date": "20230516",
              "type": "Letter"
            },
            {
              "id": "74272",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020802Orig1s042lbl.pdf",
              "date": "20230516",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20200227",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61994",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020802Orig1s034lbl.pdf",
              "date": "20200228",
              "type": "Label"
            },
            {
              "id": "61995",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020802Orig1s034ltr.pdf",
              "date": "20200228",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20151117",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20211207",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "69523",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020802Orig1s040ltr.pdf",
              "date": "20211209",
              "type": "Letter"
            },
            {
              "id": "69539",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020802Orig1s040lbl.pdf",
              "date": "20211213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20180102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50959",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802s033lbl.pdf",
              "date": "20190419",
              "type": "Label"
            },
            {
              "id": "50960",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020802s032ltr.pdf",
              "date": "20180109",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980114",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "41711",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020802_s000_ExcedrinTOC.html",
              "date": "20050713",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20140715",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13465",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf",
              "date": "20140730",
              "type": "Label"
            },
            {
              "id": "3396",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s024ltr.pdf",
              "date": "20140717",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20170913",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20140415",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13464",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf",
              "date": "20140422",
              "type": "Label"
            },
            {
              "id": "25874",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s022ltr.pdf",
              "date": "20140417",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020802",
      "sponsor_name": "HALEON US HOLDINGS",
      "openfda": {
        "application_number": [
          "NDA020802"
        ],
        "brand_name": [
          "EXCEDRIN MIGRAINE GELTABS",
          "EXCEDRIN MIGRAINE, TRAVEL BASIX",
          "EXCEDRIN MIGRAINE, CVP HEALTH",
          "EXCEDRIN MIGRAINE",
          "HEADACHE RELIEF EXTRA STRENGTH",
          "EXCEDRIN MIGRAINE RELIEF"
        ],
        "generic_name": [
          "ACETAMINOPHEN, ASPRIN, CAFFEINE",
          "ACETAMINOPHEN, ASPIRIN, AND CAFFEINE",
          "ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE",
          "ACETAMINOPHEN, ASPIRIN AND CAFFEINE",
          "ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC",
          "Lil' Drug Store Products, Inc.",
          "Allegiant Health"
        ],
        "product_ndc": [
          "0067-2035",
          "66715-6449",
          "66715-6549",
          "66715-9749",
          "0067-8201",
          "0067-2039",
          "0067-2040",
          "69168-285",
          "0067-2042"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "ASPIRIN",
          "CAFFEINE"
        ],
        "rxcui": [
          "209468",
          "308297"
        ],
        "spl_id": [
          "1006aaaa-a4ed-a80e-e063-6294a90a6bc6",
          "292c702d-fbca-eda6-e063-6394a90ac866",
          "ebe1d05e-a2d6-4092-a101-0c283ac6f95d",
          "7386648a-3c0a-4586-9b61-fd824edfdfc1",
          "cc2a55d5-3c7f-4c59-a38a-cb51e693649d",
          "62d55418-7d3d-4708-af3a-2969be915e4a",
          "27f2895c-750b-4c97-9d33-914f4df59bd2"
        ],
        "spl_set_id": [
          "cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8",
          "40aeb2c5-a37b-446d-9918-8378a75ff327",
          "920c8898-e222-4b91-afc5-04d25317ade7",
          "7ed841fb-a61c-4868-b4e5-4f2311a5e79c",
          "910d7254-d0f4-4c5c-a26e-7f8acecbe02d",
          "6197eff5-0351-42ef-bb3f-cbc26e6d0d14",
          "dd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d8"
        ],
        "package_ndc": [
          "0067-2035-20",
          "0067-2035-24",
          "0067-2035-50",
          "0067-2035-80",
          "0067-2035-91",
          "0067-2035-16",
          "66715-6449-3",
          "66715-6549-2",
          "66715-9749-3",
          "66715-9749-8",
          "66715-9749-2",
          "0067-8201-03",
          "0067-2039-02",
          "0067-2039-08",
          "0067-2039-09",
          "0067-2039-24",
          "0067-2039-30",
          "0067-2039-50",
          "0067-2039-94",
          "0067-2039-91",
          "0067-2039-83",
          "0067-2039-84",
          "0067-2039-86",
          "0067-2039-92",
          "0067-2039-77",
          "0067-2039-07",
          "0067-2039-33",
          "0067-2040-02",
          "0067-2040-03",
          "0067-2040-04",
          "0067-2040-05",
          "0067-2040-06",
          "0067-2040-07",
          "0067-2040-08",
          "0067-2040-09",
          "0067-2040-01",
          "0067-2040-11",
          "69168-285-24",
          "69168-285-37",
          "0067-2042-01",
          "0067-2042-02",
          "0067-2042-03",
          "0067-2042-04",
          "0067-2042-05",
          "0067-2042-06",
          "0067-2042-07",
          "0067-2042-08"
        ],
        "nui": [
          "N0000000160",
          "N0000008836",
          "M0001335",
          "N0000175722",
          "N0000175578",
          "N0000008832",
          "N0000175739",
          "N0000175729",
          "N0000175790",
          "M0023046"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Prostaglandin Production [PE]",
          "Decreased Platelet Aggregation [PE]",
          "Central Nervous System Stimulation [PE]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]",
          "Xanthines [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]",
          "Platelet Aggregation Inhibitor [EPC]",
          "Central Nervous System Stimulant [EPC]",
          "Methylxanthine [EPC]"
        ],
        "unii": [
          "362O9ITL9D",
          "R16CO5Y76E",
          "3G6A5W338E"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "EXCEDRIN (MIGRAINE RELIEF)",
          "active_ingredients": [
            {
              "name": "ACETAMINOPHEN",
              "strength": "250MG"
            },
            {
              "name": "ASPIRIN",
              "strength": "250MG"
            },
            {
              "name": "CAFFEINE",
              "strength": "65MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}