{ "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": "5", "submission_status": "AP", "submission_status_date": "20190125", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57453", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s005lbl.pdf", "date": "20190206", "type": "Label" }, { "id": "57524", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s005ltr.pdf", "date": "20190213", "type": "Letter" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20111221", "review_priority": "STANDARD", "submission_class_code": "TYPE 4", "submission_class_code_description": "Type 4 - New Combination", "application_docs": [ { "id": "42419", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113_advil_toc.html", "date": "20120906", "type": "Review" }, { "id": "44682", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113Orig1s000SumR.pdf", "date": "20120906", "type": "Summary Review" }, { "id": "6912", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022113s000ltr.pdf", "date": "20111228", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "20211123", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "69409", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022113Orig1s011ltr.pdf", "date": "20211124", "type": "Letter" }, { "id": "69425", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022113Orig1s011lbl.pdf", "date": "20211130", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "20180226", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "52782", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s003ltr.pdf", "date": "20180301", "type": "Letter" }, { "id": "53018", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s003lbl.pdf", "date": "20180315", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20170428", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "48171", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022113Orig1s001lbl.pdf", "date": "20170501", "type": "Label" }, { "id": "48213", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022113Orig1s001ltr.pdf", "date": "20170502", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "20190906", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59953", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s008lbl.pdf", "date": "20190910", "type": "Label" }, { "id": "59954", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s008ltr.pdf", "date": "20190910", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "20180226", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "52781", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s004ltr.pdf", "date": "20180301", "type": "Letter" }, { "id": "53017", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s004lbl.pdf", "date": "20180315", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "20170324", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "20190709", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59299", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s007; 022565Orig1s005ltr.pdf", "date": "20190710", "type": "Letter" }, { "id": "59303", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf", "date": "20190710", "type": "Label" } ] } ], "application_number": "NDA022113", "sponsor_name": "HALEON US HOLDINGS", "openfda": { "application_number": [ "NDA022113" ], "brand_name": [ "ADVIL ALLERGY AND CONGESTION RELIEF", "ADVIL MULTI-SYMPTOM COLD AND FLU" ], "generic_name": [ "CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE", "CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HCL" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0573-0196", "0573-2161", "0573-0190" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CHLORPHENIRAMINE MALEATE", "IBUPROFEN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1310503" ], "spl_id": [ "ac233de1-41cf-4ef0-a7b4-30f395c88c1a", "4042cf07-a239-1ae9-e063-6394a90acd01" ], "spl_set_id": [ "a6cc97d8-252a-4527-a470-6d9e356342fd", "7671d104-3c5c-4f63-b6b1-6c91c22592f8" ], "package_ndc": [ "0573-0196-01", "0573-0196-10", "0573-0196-20", "0573-0196-02", "0573-2161-03", "0573-0190-10", "0573-0190-20", "0573-0190-01", "0573-0190-30", "0573-0190-03", "0573-0190-02" ], "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": [ "04JA59TNSJ", "V1Q0O9OJ9Z", "WK2XYI10QM" ] }, "products": [ { "product_number": "001", "reference_drug": "Yes", "brand_name": "ADVIL ALLERGY AND CONGESTION RELIEF", "active_ingredients": [ { "name": "CHLORPHENIRAMINE MALEATE", "strength": "4MG" }, { "name": "IBUPROFEN", "strength": "200MG" }, { "name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Over-the-counter" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "ADVIL MULTI-SYMPTOM COLD & FLU", "active_ingredients": [ { "name": "CHLORPHENIRAMINE MALEATE", "strength": "4MG" }, { "name": "IBUPROFEN", "strength": "200MG" }, { "name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Over-the-counter" } ] } ] }