{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19990913",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20758",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.html",
              "date": "19990913",
              "type": "Review"
            },
            {
              "id": "2850",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf",
              "date": "19990913",
              "type": "Letter"
            },
            {
              "id": "34942",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf",
              "date": "19990913",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20160829",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45181",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020603Orig1s021lbl.pdf",
              "date": "20160829",
              "type": "Label"
            },
            {
              "id": "45217",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020603Orig1s021ltr.pdf",
              "date": "20160829",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20090429",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25299",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020603s013ltr.pdf",
              "date": "20090506",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20060227",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25298",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020603s011ltr.pdf",
              "date": "20060301",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20020116",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "12823",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf",
              "date": "20020116",
              "type": "Label"
            },
            {
              "id": "2851",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20603s5ltr.pdf",
              "date": "20020116",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19990415",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "20759",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S3_InfantsMotrin.pdf",
              "date": "19990415",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980612",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41472",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603s001_Ibuprofen.html",
              "date": "19980612",
              "type": "Review"
            },
            {
              "id": "12822",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_prntlbl.pdf",
              "date": "19980612",
              "type": "Label"
            },
            {
              "id": "2849",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_Approv.pdf",
              "date": "19980612",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19960610",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20151204",
          "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": "20170316",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47575",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf",
              "date": "20170317",
              "type": "Label"
            },
            {
              "id": "47593",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020603Orig1s022ltr.pdf",
              "date": "20170320",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20100715",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2852",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020603s014ltr.pdf",
              "date": "20100719",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20010503",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA020603",
      "sponsor_name": "KENVUE BRANDS",
      "openfda": {
        "application_number": [
          "NDA020603"
        ],
        "brand_name": [
          "INFANTS MOTRIN",
          "MOTRIN INFANTS"
        ],
        "generic_name": [
          "IBUPROFEN"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "50580-100",
          "50580-198"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "204442",
          "854762"
        ],
        "spl_id": [
          "55761fde-7caa-c7f4-e063-6294a90ad5b4",
          "519a1a5f-e816-0d56-e063-6294a90a337d"
        ],
        "spl_set_id": [
          "c2302bfe-b367-4867-b803-29f066a42dc7",
          "c57f6ded-c0bd-45ae-823a-4c02ce334d98"
        ],
        "package_ndc": [
          "50580-100-18",
          "50580-198-50",
          "50580-198-51",
          "50580-198-52",
          "50580-198-05"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "WK2XYI10QM"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CHILDREN'S MOTRIN",
          "active_ingredients": [
            {
              "name": "IBUPROFEN",
              "strength": "40MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION/DROPS",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}