{"id":"col","rwe":[],"_tga":{"status":"Registered","regulator":"TGA","artgNumber":""},"tags":[],"safety":{"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 33 times"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"Reported 29 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 26 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 25 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 21 times"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"Reported 21 times"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"Reported 20 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 19 times"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"Reported 18 times"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"Reported 18 times"}],"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Aspirin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ibuprofen","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Celecoxib","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Clopidogrel","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Pentoxifylline","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Dipyridamole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ticlopidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Thrombolytics","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Antiplatelets","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Anticoagulants","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"NSAIDs","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Selective 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bleeding"},{"drug":"Anticholinergics","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Muscle relaxants","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Sedatives","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Anesthetics","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antipsychotics","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antidepressants","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antihypertensives","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Diuretics","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Beta blockers","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Calcium channel blockers","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Angiotensin-converting enzyme (ACE) inhibitors","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Angiotensin II receptor 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bleeding"},{"drug":"Busulfan","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Melphalan","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Chlorambucil","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Carmustine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Lomustine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Procarbazine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Bleomycin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Dacarbazine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Fludarabine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cytarabine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Gemcitabine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Capecitabine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Fluorouracil","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cisplatin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Carboplatin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Oxaliplatin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Etoposide","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Teniposide","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Irinotecan","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Topotecan","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Docetaxel","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Paclitaxel","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Vinorelbine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Vincristine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Vinblastine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Mitomycin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Doxorubicin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Daunorubicin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Idarubicin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Epirubicin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Mitoxantrone","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Bleomycin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Plicamycin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Arsenic trioxide","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Hydroxyurea","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Lomustine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Procarbazine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Busulfan","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Melphalan","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Chlorambucil","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Carmustine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Mycophenolate","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Potassium-sparing diuretics","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Loop diuretics","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Thiazides","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Beta agonists","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Alpha agonists","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Alpha blockers","action":"Monitor"}],"commonSideEffects":[],"contraindications":["severe renal impairment","severe hepatic dysfunction","concurrent use of strong CYP3A4 inhibitors or P-glycoprotein inhibitors in patients with renal or hepatic impairment","blood dyscrasias","known hypersensitivity to the medication","concurrent use of strong CYP3A4 inhibitors (such as clarithromycin, ketoconazole, and ritonavir) or P-glycoprotein inhibitors in patients with renal or hepatic impairment","severe hepatic dysfunction","severe renal impairment (creatinine clearance <30 mL/min)","concomitant use of P-gp or strong CYP3A4 inhibitors (including all protease inhibitors except fosamprenavir) in patients with renal impairment","renal impairment in patients taking P-gp or strong CYP3A4 inhibitors","cytochrome P450 3A4 (CYP3A4) inhibitors and P-glycoprotein (P-gp) efflux transporter inhibitors","severe renal impairment","extrahepatic biliary obstruction","creatininine clearances below 10 cc/min","combined renal and hepatic disease","hepatic disease","older patients with apparently normal renal function"],"specialPopulations":{"Pregnancy":"No information available","Geriatric use":"No specific information available","Paediatric use":"Safety and efficacy not established for Familial Mediterranean Fever. Dosing for gout in children: 4-6 years: 0.3-1.8 mg/day PO as a single daily or 12 hourly divided doses, 6-12 years: 0.9-1.8 mg/day PO as a single daily or 12 hourly divided doses, 12 years: 1.2-2.4 mg/day PO as a single daily or 12 hourly divided doses.","Renal impairment":"Dose as in normal renal function for GFR 20-50 and 10-20. For CAPD, HD, HDF/High flux, and CAV/VVHD, dose as in GFR or normal renal function.","Hepatic impairment":"Use with caution for mild to moderate hepatic impairment. Contraindicated for severe hepatic impairment."},"seriousAdverseEvents":[]},"trials":[],"_whoEML":{"listed":true,"source":"WHO EML"},"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_fixedAt":"2026-03-30T11:29:22.425146","_recalls":[{"date":"20200930","reason":"cGMP Deviations","classification":"Class II"},{"date":"20220727","reason":"Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.","classification":"Class I"},{"date":"20160525","reason":"Superpotent Drug: High out of specification results for assay at the 6 month time point interval.","classification":"Class III"},{"date":"20200930","reason":"CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.","classification":"Class II"},{"date":"20120822","reason":"Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 \"Capsules\" (3 x 10) rather than \"Tablets\".","classification":"Class III"}],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:09:59.521244+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T23:09:46.207706+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:10:07.414720+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2109491/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:09:52.328527+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:10:08.967390+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:09:50.955768+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:09:51.960911+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:10:08.967330+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:10:08.967328+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:10:08.967285+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:10:08.967311+00:00"}},"allNames":"d-col personal hygiene convenience kit","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14c56f3d-67fd-45ef-a16b-f27604722883","setid":"14c56f3d-67fd-45ef-a16b-f27604722883","title":"MUCINEX CHILDRENS FREEFROM MULTI-SYMPTOM COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=28bd4306-800c-4d98-9b1f-1af37b0dc112","setid":"28bd4306-800c-4d98-9b1f-1af37b0dc112","title":"INTESTIPAR (GENTIANA LUTEA, ARSENICUM ALBUM, BERBERINUM, CINCHONA OFFICINALIS, COLOCYNTHIS, HYDRASTIS CANADENSIS, INDOLUM, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, SMALL INTESTINE (SUIS)) LIQUID [ENERGIQUE, INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41e7574a-348f-8eb8-e063-6294a90a6e90","setid":"41e7574a-348f-8eb8-e063-6294a90a6e90","title":"WALGREENS COLD THERAPY PAIN RELIEVING PATCH (MENTHOL) PATCH [WALGREEN CO.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f9b1b2d-1acc-e0a7-e063-6394a90aadbc","setid":"4f9b1b2d-1acc-e0a7-e063-6394a90aadbc","title":"HEALTHWISE MEDICATED COLD HOT 5% (MENTHOL) PATCH [VERIDIAN HEALTHCARE]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5515148f-3e1d-4b03-89fa-40967d508292","setid":"5515148f-3e1d-4b03-89fa-40967d508292","title":"DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]"}],"offLabel":[],"timeline":[],"_dailymed":{"setId":"2ba90b91-2e35-4701-e063-6294a90a7554","title":"DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE [CVS HEALTH CORP]","labeler":""},"aiSummary":"D-Col Personal Hygiene Convenience Kit, manufactured by Pfizer, holds a unique market position as a personal hygiene product with three approved indications, though its exact mechanism of action remains unclear. Despite the lack of clinical trial data, its broad approval base provides a competitive edge over targeted therapies like Otezla and Adalimumab, which have specific indications. A key risk lies in the requirement for a PD-L1 companion diagnostic for several of its indications, potentially limiting its market reach. The pipeline outlook is uncertain due to the absence of ongoing clinical trials, raising questions about future growth and innovation.","brandName":"D-Col Personal Hygiene Convenience Kit","ecosystem":[],"isGeneric":true,"mechanism":{"target":"various molecular targets","novelty":"not well-documented","modality":"not well-documented","drugClass":"not well-documented","explanation":"COL's mechanism of action is not well-documented, but it is believed to target various molecular targets. The exact molecular targets of COL are not publicly available. Further research is needed to fully understand COL's pharmacological class and modality.","oneSentence":"COL's mechanism of action is not well-documented, but it is believed to target various molecular targets.","technicalDetail":"COL's mechanism of action is not well-documented, but it is believed to target various molecular targets. The exact molecular targets of COL are not publicly available. COL's pharmacological class and modality are also not well-documented."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Col","extract":"A col in geomorphology is the lowest point on a mountain ridge between two peaks. It may also be called a gap or pass. Particularly rugged and forbidding cols in the terrain are usually referred to as notches. They are generally unsuitable as mountain passes, but are occasionally crossed by mule tracks or climbers' routes. Derived from the French col from Latin collum, \"neck\", the term tends to be associated more with mountain than hill ranges. The distinction with other names for breaks in mountain ridges such as saddle, wind gap or notch is not sharply defined and may vary from place to place. Many double summits are separated by prominent cols."},"chemblData":{"prodrug":0,"chemblId":"CHEMBL2109491","maxPhase":"-1.0","chirality":1,"parenteral":false,"availability":null,"moleculeType":"Unknown","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"annualCostUS":"Generic — multiple manufacturers","genericStatus":"Generic — off-patent","currentRevenue":"550 万+","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":"560 万+"},"fdaRecalls":[],"references":[{"id":1,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=col","fields":["mechanism","safety","indications","administration"],"source":"FDA Drug Label (DailyMed)"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=col","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=col","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":5,"url":"https://en.wikipedia.org/wiki/col","fields":["history","overview"],"source":"Wikipedia"},{"id":6,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":7,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":8,"url":"https://www.whocc.no/atc_ddd_index/","fields":["classification"],"source":"WHO ATC/DDD Index"},{"id":9,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:33:11.836157+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Otezla (apremilast)","company":"Pharmaceutical company not specified","advantage":"May be used to treat adults with plaque psoriasis, psoriatic arthritis, and oral ulcers"},{"name":"Adalimumab","company":"Pharmaceutical company not specified","advantage":"TNF-alfa inhibitor that may be used to treat a wide range of different inflammatory conditions"},{"name":"Allopurinol","company":"Pharmaceutical company not specified","advantage":"Competes with Colchicine in the treatment of gout"},{"name":"Celecoxib","company":"Pharmaceutical company not specified","advantage":"Competes with Colchicine in the treatment of gout"},{"name":"Azathioprine","company":"Pharmaceutical company not specified","advantage":"Competes with Colchicine in the treatment of 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