{"id":"histamine","rwe":[],"_fda":{"id":"097603dc-2280-2bef-e063-6294a90a1bdd","set_id":"03ec87c5-6669-4afb-8d9c-c8dc9907495d","openfda":{"unii":["3POA0Q644U"],"route":["TOPICAL"],"spl_id":["097603dc-2280-2bef-e063-6294a90a1bdd"],"brand_name":["BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender"],"spl_set_id":["03ec87c5-6669-4afb-8d9c-c8dc9907495d"],"package_ndc":["76102-329-00"],"product_ndc":["76102-329"],"generic_name":["HISTAMINE DIHYDROCHLORIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["HISTAMINE DIHYDROCHLORIDE"],"manufacturer_name":["BAKER'S BEST HEALTH PRODUCTS, INC."],"application_number":["M017"],"is_original_packager":[true]},"purpose":["Purpose Topical Analgesic"],"version":"3","warnings":["Warnings: For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult a physician. Keep out of reach of children. If swallowed, consult a physician ASAP. Do not apply to wounds or damaged skin. Do not bandage tightly. If pregnant or breast feeding, contact a physician prior to use."],"effective_time":"20231106","active_ingredient":["Active Ingredients Histamine DHCL (0.03%) Purpose Topical Analgesic"],"inactive_ingredient":["Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Butylene Glycol, Cannabis Sativa (Hemp) Seed Oil, Chondroitin Sulfate, Emu Oil, Ethylhexyl Stearate, Glucosamine Sulfate, Helianthus Annuus (Sunflower) Seed Oil, Hydrochloric Acid, C13-14 Isoparaffin, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Methylisothiazolinone, Methylsulfonylmethane (MSM), Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamine E), Trideceth-6."],"indications_and_usage":["Indications: For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains."],"spl_unclassified_section":["Drug Facts","Additional Information: Store at room temperature."],"dosage_and_administration":["Directions: Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician."],"spl_product_data_elements":["BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender HISTAMINE DIHYDROCHLORIDE ALOE VERA LEAF WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE BUTYLENE GLYCOL CANNABIS SATIVA SEED OIL EMU OIL ETHYLHEXYL STEARATE GLUCOSAMINE SULFATE SUNFLOWER OIL HYDROCHLORIC ACID C13-14 ISOPARAFFIN LAURETH-7 LAVENDER OIL METHYLISOTHIAZOLINONE DIMETHYL SULFONE POTASSIUM SORBATE EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE TRIDECETH-6 HISTAMINE DIHYDROCHLORIDE HISTAMINE"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, contact a physician prior to use."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, consult a physician ASAP. Do not apply to wounds or damaged skin. Do not bandage tightly."],"package_label_principal_display_panel":["Package Labeling: Label"]},"tags":[{"label":"histamine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H3 receptor","category":"target"},{"label":"HRH3","category":"gene"},{"label":"HRH4","category":"gene"},{"label":"TAAR1","category":"gene"},{"label":"L03AX14","category":"atc"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Acute myeloid leukemia, disease","category":"indication"},{"label":"Hyposensitization to allergens","category":"indication"},{"label":"Osteoarthritis","category":"indication"},{"label":"Lilly","category":"company"},{"label":"Approved 1930s","category":"decade"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Agonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FALSE NEGATIVE INVESTIGATION RESULT","source":"FDA FAERS","actionTaken":"48 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"38 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"16 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"13 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"13 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"13 reports"},{"date":"","signal":"ANAPHYLACTIC REACTION","source":"FDA FAERS","actionTaken":"12 reports"},{"date":"","signal":"BACK PAIN","source":"FDA FAERS","actionTaken":"12 reports"}],"commonSideEffects":[{"effect":"Flushing","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Urticaria","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Metallic taste","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal cramps","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Abnormal vasomotor function","Acute exacerbation of asthma","Acute nephropathy","Alcoholism","Angina pectoris","Angle-closure glaucoma","Arteriosclerosis obliterans","Asthma","Benign prostatic hyperplasia","Bladder outflow obstruction","Chronic idiopathic constipation","Conduction disorder of the heart","Coronary arteriosclerosis","Diabetes mellitus","Diabetes mellitus type 1","Disorder of cardiovascular system","Edema","Feeling agitated","Glaucoma","Heart valve disorder","Hypertensive disorder","Hypertensive urgency","Hyperthyroidism","Low blood pressure","Mild pre-eclampsia"],"specialPopulations":{"Pregnancy":"Histamine should be given during pregnancy only if clearly needed. Exposure or repeated doses should be avoided due to histamines known ability to contract uterine muscle.","Paediatric use":"Histamine solutions for percutaneous testing have been given safely in infants and young children. Small skin test reactions should be anticipated in neonates and infants."},"seriousAdverseEvents":[{"effect":"Anaphylactic reaction","drugRate":"","severity":"serious"},{"effect":"Bronchial constriction","drugRate":"","severity":"serious"},{"effect":"Asthma","drugRate":"","severity":"serious"},{"effect":"Marked hypotension","drugRate":"","severity":"serious"},{"effect":"Marked hypertension","drugRate":"","severity":"serious"},{"effect":"Generalized allergic manifestations","drugRate":"","severity":"serious"},{"effect":"Systemic reactions","drugRate":"","severity":"serious"},{"effect":"Vasomotor collapse","drugRate":"","severity":"serious"},{"effect":"Profound shock","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Eli Lilly","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=HISTAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:12:23.101166+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:12:29.992469+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HISTAMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:12:30.871877+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:12:20.897402+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:12:20.897627+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:12:32.478192+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1533310/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:12:31.374196+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M017","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:12:20.897650+00:00"}},"allNames":"eramin","offLabel":[],"synonyms":["ceplene","histamine","5-imidazoleethylamine","eramin","ergamine","ergotidine","histamine dihydrochloride","histamine phosphate","histamine diphosphate"],"timeline":[{"date":"1939-04-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Lilly)"}],"aiSummary":"Eramin, also known as histamine, is a small molecule histamine drug originally developed by Lilly and currently owned by the same company. It targets the histamine H3 receptor and was FDA approved in 1939 for various indications including acute myeloid leukemia, hyposensitization to allergens, and osteoarthritis. Eramin is off-patent and has no active Orange Book patents, meaning it is available as a generic medication. However, there are currently no generic manufacturers of Eramin. As an off-patent medication, key safety considerations should be carefully evaluated.","approvals":[{"date":"1939-04-25","orphan":false,"company":"LILLY","regulator":"FDA"}],"brandName":"Eramin","ecosystem":[{"indication":"Acute myeloid leukemia, disease","otherDrugs":[{"name":"aldesleukin","slug":"aldesleukin","company":"Chiron"},{"name":"azacitidine","slug":"azacitidine","company":"Celgene"},{"name":"cytarabine","slug":"cytarabine","company":""},{"name":"daunorubicin","slug":"daunorubicin","company":""}],"globalPrevalence":800000},{"indication":"Hyposensitization to allergens","otherDrugs":[],"globalPrevalence":null},{"indication":"Osteoarthritis","otherDrugs":[{"name":"aceclofenac","slug":"aceclofenac","company":""},{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"celecoxib","slug":"celecoxib","company":"Gd Searle"},{"name":"choline magnesium trisalicylate","slug":"choline-magnesium-trisalicylate","company":""}],"globalPrevalence":655000000}],"mechanism":{"target":"Histamine H3 receptor","novelty":"First-in-class","targets":[{"gene":"HRH3","source":"DrugCentral","target":"Histamine H3 receptor","protein":"Histamine H3 receptor"},{"gene":"HRH4","source":"DrugCentral","target":"Histamine H4 receptor","protein":"Histamine H4 receptor"},{"gene":"TAAR1","source":"DrugCentral","target":"Trace amine-associated receptor 1","protein":"Trace amine-associated receptor 1"},{"gene":"HRH2","source":"DrugCentral","target":"Histamine H2 receptor","protein":"Histamine H2 receptor"},{"gene":"MIF","source":"DrugCentral","target":"Macrophage migration inhibitory factor","protein":"Macrophage migration inhibitory factor"},{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor"}],"modality":"Small Molecule","drugClass":"histamine","explanation":"","oneSentence":"","technicalDetail":"Histamine exerts its effects by binding to the histamine H3 receptor, a G protein-coupled receptor that inhibits the release of histamine from neurons, thereby modulating neurotransmitter release and influencing various physiological processes."},"commercial":{"launchDate":"1939","_launchSource":"DrugCentral (FDA 1939-04-25, LILLY)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1375","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=HISTAMINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HISTAMINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:58:55.261132","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:12:34.222728+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[{"form":"INJECTION","route":"PERCUTANEOUS","company":"Jubilant HollisterStier LLC","brandName":"Positive Skin Test Control - Histamine","isOriginal":false,"marketingStatus":"BLA"}],"competitors":[{"drugName":"pegademase","drugSlug":"pegademase","fdaApproval":"1990-03-21","relationship":"same-class"},{"drugName":"glatiramer acetate","drugSlug":"glatiramer-acetate","fdaApproval":"1996-12-20","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"plerixafor","drugSlug":"plerixafor","fdaApproval":"2008-12-15","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"elapegademase","drugSlug":"elapegademase","fdaApproval":"2018-10-05","relationship":"same-class"}],"genericName":"histamine","indications":{"approved":[{"name":"Acute myeloid leukemia, disease","source":"DrugCentral","snomedId":91861009,"regulator":"FDA","usPrevalence":null,"globalPrevalence":800000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency 2018[INST])"},{"name":"Hyposensitization to allergens","source":"DrugCentral","snomedId":182678001,"regulator":"FDA","eligibility":null},{"name":"Osteoarthritis","source":"DrugCentral","snomedId":396275006,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":655000000,"prevalenceMethod":"curated","prevalenceSource":"Arthritis Res Ther, 2023 (PMID:36991481)"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"pegademase","brandName":"pegademase","genericName":"pegademase","approvalYear":"1990","relationship":"same-class"},{"drugId":"glatiramer-acetate","brandName":"glatiramer acetate","genericName":"glatiramer acetate","approvalYear":"1996","relationship":"same-class"},{"drugId":"plerixafor","brandName":"plerixafor","genericName":"plerixafor","approvalYear":"2008","relationship":"same-class"},{"drugId":"elapegademase","brandName":"elapegademase","genericName":"elapegademase","approvalYear":"2018","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04548999","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-12-03","conditions":["Multiple 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