{ "$schema": "./source-registry.schema.json", "title": "Octenidine.org Source Registry", "publisher": "Octenidine.org", "description": "A public data copy of the sources Octenidine.org uses to keep octenidine dihydrochloride reference material accurate, bounded, and useful.", "generatedAt": "2026-05-22", "canonicalData": "Octenidine.org maintained registry used by the website", "recordCount": 23, "tierDefinitions": [ { "tier": "tier_1_identity_regulatory_safety", "label": "Tier 1: identity, regulatory, and safety sources", "use": "Official identity, regulator, label, and safety facts." }, { "tier": "tier_2_evidence_synthesis_guideline", "label": "Tier 2: evidence syntheses and guidelines", "use": "Broad clinical or evidence context, including systematic reviews, guidelines, health technology reports, and Cochrane reviews." }, { "tier": "tier_3_primary_literature", "label": "Tier 3: primary literature", "use": "Exact study findings from trials, microbiology papers, analytical studies, in vitro work, ex vivo work, or animal studies." }, { "tier": "tier_4_product_supplier_document", "label": "Tier 4: product and supplier documents", "use": "Product-specific facts such as manufacturer pages, supplier documents, safety data sheets, package leaflets, and instructions for use." }, { "tier": "tier_5_context_only", "label": "Tier 5: context only", "use": "Search leads and background context. Article claims belong with reviewed records, labels, regulators, or papers rather than general discovery pages." } ], "useForDefinitions": [ { "useFor": "chemical-identity", "meaning": "Names, synonyms, identifiers, structure, formula, and official substance record context." }, { "useFor": "regulatory-context", "meaning": "Regulatory terminology, official status pages, hazard communication, label concepts, or jurisdiction-specific context when the source itself supports the statement." }, { "useFor": "safety-context", "meaning": "Safety, exposure, warnings, poison-control routing, patient questions, or adverse-event context within the source limits." }, { "useFor": "clinical-evidence", "meaning": "Clinical evidence summaries, trial context, outcome limits, or evidence gaps in the population and setting studied." }, { "useFor": "microbiology", "meaning": "Antimicrobial activity, susceptibility, mechanism, biofilm, membrane, or laboratory-model context with study limits retained." }, { "useFor": "formulation-context", "meaning": "Formulation, co-ingredient, handling, safety data sheet, or document-structure context when supported by the source." }, { "useFor": "search-discovery", "meaning": "Discovery routes that help find stronger records. These do not carry article claims by themselves." } ], "dateFields": { "lastChecked": "Date this registry record was last reviewed by Octenidine.org.", "reviewCadenceMonths": "Expected interval, in months, before the record receives another review.", "nextReviewDue": "Calculated from lastChecked plus reviewCadenceMonths." }, "recordGuidance": { "useFor": "Topics this record can help support when the article claim stays within the source limits.", "notFor": "Claims or tasks this record should not be used to support.", "citationNote": "Short note on how the record may be cited or interpreted.", "editorialNotes": "Additional public-safe context where a record needs a careful reading." }, "sources": [ { "id": "pubchem-octenidine-hydrochloride", "title": "Octenidine Hydrochloride, CID 51166", "publisher": "PubChem, National Library of Medicine", "url": "https://pubchem.ncbi.nlm.nih.gov/compound/Octenidine-Hydrochloride", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official chemical substance record", "lastChecked": "2026-05-06", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-06", "useFor": [ "chemical-identity", "search-discovery" ], "notFor": [ "clinical effectiveness claims", "product-specific label instructions", "jurisdiction-specific approval claims" ], "citationNote": "Supports names, identifiers, structure, formula, synonyms, and links to other official substance records.", "editorialNotes": [ "PubChem brings together data from multiple sources; high-risk regulatory or safety details should be checked against the linked authority." ] }, { "id": "fda-gsrs-u84956nu4b", "title": "OCTENIDINE HYDROCHLORIDE, UNII U84956NU4B", "publisher": "U.S. Food and Drug Administration Global Substance Registration System", "url": "https://precision.fda.gov/uniisearch/srs/unii/u84956nu4b", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official substance identity record", "lastChecked": "2026-05-06", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-06", "useFor": [ "chemical-identity", "regulatory-context" ], "notFor": [ "FDA approval claims", "clinical benefit claims", "consumer use instructions" ], "citationNote": "Supports UNII, preferred substance name, formula, and synonym mapping. The GSRS page states that UNII availability does not imply regulatory review or approval.", "editorialNotes": [] }, { "id": "echa-substance-100068035", "title": "Octenidine dihydrochloride substance information", "publisher": "European Chemicals Agency", "url": "https://chem.echa.europa.eu/100.068.035", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official chemical substance information", "lastChecked": "2026-05-06", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-06", "useFor": [ "chemical-identity", "regulatory-context", "safety-context" ], "notFor": [ "human clinical effectiveness", "medical product authorization", "finished-product directions" ], "citationNote": "Supports EU chemical identity, EC/CAS linkage, and chemical regulatory context when the exact page supports the statement.", "editorialNotes": [] }, { "id": "ema-mrl-octenidine-dihydrochloride", "title": "Octenidine dihydrochloride maximum residue limit", "publisher": "European Medicines Agency", "url": "https://www.ema.europa.eu/en/medicines/veterinary/mrl/octenidine-dihydrochloride-maximum-residue-limit", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official veterinary regulatory assessment page", "lastChecked": "2026-05-06", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-06", "useFor": [ "regulatory-context", "safety-context" ], "notFor": [ "human antiseptic approval claims", "consumer treatment guidance", "general efficacy claims" ], "citationNote": "Supports the EMA veterinary maximum-residue-limit context and related regulatory history.", "editorialNotes": [] }, { "id": "ema-orphan-eu310755", "title": "EU/3/10/755 orphan designation for prevention of late-onset sepsis in premature infants", "publisher": "European Medicines Agency", "url": "https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu310755", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official orphan designation page", "lastChecked": "2026-05-06", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-06", "useFor": [ "regulatory-context" ], "notFor": [ "approval or authorization claims", "neonatal treatment guidance", "evidence of clinical effectiveness" ], "citationNote": "Supports the narrow orphan-designation history and the EMA page's own development-stage language.", "editorialNotes": [ "Orphan designation is not marketing authorization and should not be read as approval for use." ] }, { "id": "ncbi-bookshelf-antiseptic-cleansers-wounds", "title": "Antimicrobial or Antiseptic Cleansers for Wounds", "publisher": "NCBI Bookshelf", "url": "https://www.ncbi.nlm.nih.gov/books/NBK595337/", "tier": "tier_2_evidence_synthesis_guideline", "sourceType": "health technology evidence report", "lastChecked": "2026-05-06", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-06", "useFor": [ "clinical-evidence", "safety-context" ], "notFor": [ "chemical identity", "product label instructions", "claims outside wound-cleanser evidence reviewed in the report" ], "citationNote": "Supports cautious wound-care evidence summaries and limitations, including when evidence is mixed or not statistically significant.", "editorialNotes": [] }, { "id": "pmc-clinical-evidence-review-2023", "title": "Clinical Evidence for the Use of Octenidine Dihydrochloride to Prevent Healthcare-Associated Infections and Decrease Staphylococcus aureus Carriage or Transmission", "publisher": "PubMed Central", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10145019/", "tier": "tier_2_evidence_synthesis_guideline", "sourceType": "peer-reviewed narrative review", "lastChecked": "2026-05-06", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-06", "useFor": [ "clinical-evidence", "safety-context" ], "notFor": [ "clinical recommendations", "product substitution guidance", "claims outside the reviewed clinical settings" ], "citationNote": "Supports clinical-evidence summaries and discussion of evidence gaps while preserving the review's limitations.", "editorialNotes": [] }, { "id": "pmc-microbicidal-activity-1985", "title": "Microbicidal activity of octenidine hydrochloride, a new alkanediylbis[pyridine] germicidal agent", "publisher": "Antimicrobial Agents and Chemotherapy / PubMed Central", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC180329/", "tier": "tier_3_primary_literature", "sourceType": "primary microbiology study", "lastChecked": "2026-05-06", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-06", "useFor": [ "microbiology" ], "notFor": [ "modern clinical effectiveness claims", "human treatment instructions", "finished-product label claims" ], "citationNote": "Supports historical and microbiology context when in vitro or model limits remain clear.", "editorialNotes": [] }, { "id": "pmc-chlorhexidine-octenidine-susceptibility-2022", "title": "Chlorhexidine and octenidine susceptibility of bacterial isolates from clinical samples in a three-armed cluster randomised decolonisation trial", "publisher": "PubMed Central", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC9749986/", "tier": "tier_3_primary_literature", "sourceType": "primary clinical microbiology study", "lastChecked": "2026-05-06", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-06", "useFor": [ "clinical-evidence", "microbiology" ], "notFor": [ "site-wide comparative superiority claims", "consumer instructions", "claims beyond susceptibility outcomes and study context" ], "citationNote": "Supports susceptibility and study-context discussion when design and limitations are described.", "editorialNotes": [] }, { "id": "cochrane-wound-cleansing-venous-leg-ulcers", "title": "Wound cleansing for treating venous leg ulcers", "publisher": "Cochrane", "url": "https://www.cochrane.org/evidence/CD011675_does-cleaning-venous-leg-ulcers-help-them-heal", "tier": "tier_2_evidence_synthesis_guideline", "sourceType": "Cochrane evidence synthesis", "lastChecked": "2026-05-07", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-07", "useFor": [ "clinical-evidence", "safety-context" ], "notFor": [ "wound-care instructions", "product-specific label claims", "claims outside venous leg ulcer cleansing evidence" ], "citationNote": "Supports cautious venous leg ulcer wound-cleansing evidence limits and uncertainty language.", "editorialNotes": [] }, { "id": "mdpi-antiseptic-agents-chronic-wounds-2022", "title": "Antiseptic Agents for Chronic Wounds: A Systematic Review", "publisher": "Antibiotics / MDPI", "url": "https://www.mdpi.com/2079-6382/11/3/350", "tier": "tier_2_evidence_synthesis_guideline", "sourceType": "systematic review", "lastChecked": "2026-05-07", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-07", "useFor": [ "clinical-evidence", "safety-context" ], "notFor": [ "treatment instructions", "product rankings", "claims outside chronic-wound antiseptic evidence" ], "citationNote": "Supports chronic-wound antiseptic evidence summaries when octenidine limitations and comparator details stay visible.", "editorialNotes": [] }, { "id": "pubmed-vanscheidt-octenidine-venous-leg-ulcers-2012", "title": "Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic", "publisher": "International Wound Journal / PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/22074592/", "tier": "tier_3_primary_literature", "sourceType": "primary randomized controlled trial record", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "clinical-evidence", "safety-context" ], "notFor": [ "general wound-care recommendations", "claims about octenidine dihydrochloride alone", "claims outside chronic venous leg ulcers and the studied product context" ], "citationNote": "Supports exact venous leg ulcer study context when formulation, comparator, and outcome limits are retained.", "editorialNotes": [] }, { "id": "sciencedirect-malanovic-octenidine-mechanism-2020", "title": "Octenidine: Novel insights into the detailed killing mechanism of Gram-negative bacteria at a cellular and molecular level", "publisher": "International Journal of Antimicrobial Agents / PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32853670/", "tier": "tier_3_primary_literature", "sourceType": "primary mechanism study", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "microbiology" ], "notFor": [ "patient outcome claims", "clinical effectiveness claims", "finished-product label instructions" ], "citationNote": "Supports mechanism language for E. coli and model membrane systems when in vitro limits remain explicit.", "editorialNotes": [] }, { "id": "pubmed-rzycki-octenidine-chlorhexidine-membranes-2021", "title": "Unraveling the mechanism of octenidine and chlorhexidine on membranes: Does electrostatics matter?", "publisher": "Biophysical Journal / PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34214528/", "tier": "tier_3_primary_literature", "sourceType": "primary membrane biophysics study", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "microbiology" ], "notFor": [ "clinical superiority claims", "patient outcome claims", "broad resistance or safety conclusions" ], "citationNote": "Supports model-membrane mechanism discussion and cautions against oversimplified electrostatic explanations.", "editorialNotes": [] }, { "id": "osha-hazcom-appendix-d-sds", "title": "APPENDIX D TO ยง1910.1200 - SAFETY DATA SHEETS", "publisher": "Occupational Safety and Health Administration", "url": "https://www.osha.gov/hazcom/appendix-d", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official hazard communication standard appendix", "lastChecked": "2026-05-07", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-07", "useFor": [ "regulatory-context", "safety-context" ], "notFor": [ "clinical safety claims", "supplier quality claims", "non-U.S. legal advice or workplace compliance advice" ], "citationNote": "Supports U.S. SDS format and section-structure discussion for hazard communication context.", "editorialNotes": [] }, { "id": "medlineplus-evaluating-health-information", "title": "Evaluating Health Information", "publisher": "MedlinePlus / National Library of Medicine", "url": "https://medlineplus.gov/evaluatinghealthinformation.html", "tier": "tier_5_context_only", "sourceType": "official consumer health information guidance", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "safety-context", "search-discovery" ], "notFor": [ "octenidine-specific clinical claims", "product label instructions", "regulatory status claims" ], "citationNote": "Supports consumer guidance on checking source ownership, purpose, evidence, review, and update dates.", "editorialNotes": [] }, { "id": "fda-otc-drug-facts-label", "title": "The Over-the-Counter Drug Facts Label", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/understanding-over-counter-medicines/over-counter-drug-facts-label", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official consumer product-label guidance", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "safety-context", "regulatory-context" ], "notFor": [ "claims that octenidine products are U.S. OTC drugs", "product-specific use instructions", "clinical effectiveness claims" ], "citationNote": "Supports general U.S. OTC Drug Facts label concepts such as active ingredient, warnings, directions, and other information.", "editorialNotes": [] }, { "id": "hrsa-poison-help-calling", "title": "Calling Poison Help", "publisher": "Health Resources and Services Administration", "url": "https://poisonhelp.hrsa.gov/faq/calling-poison-help", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official U.S. poison-control public guidance", "lastChecked": "2026-05-07", "reviewCadenceMonths": 6, "nextReviewDue": "2026-11-07", "useFor": [ "safety-context" ], "notFor": [ "non-U.S. emergency routing", "product-specific treatment instructions", "clinical safety claims for routine use" ], "citationNote": "Supports U.S.-specific poison-help routing and information to have ready during a poison-center call.", "editorialNotes": [] }, { "id": "medlineplus-talking-with-your-doctor", "title": "Talking With Your Doctor", "publisher": "MedlinePlus / National Library of Medicine", "url": "https://medlineplus.gov/talkingwithyourdoctor.html", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official patient communication guidance", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "safety-context" ], "notFor": [ "octenidine-specific clinical claims", "product-specific use instructions", "emergency exposure management" ], "citationNote": "Supports patient preparation, question lists, note-taking, and follow-up communication guidance.", "editorialNotes": [] }, { "id": "fda-topical-antiseptic-products", "title": "Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official topical antiseptic product class page", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "safety-context", "regulatory-context" ], "notFor": [ "octenidine-specific clinical claims", "finished-product directions", "claims outside the product and jurisdiction named by the source" ], "citationNote": "Supports general topical antiseptic product-category context while keeping product-specific claims separate.", "editorialNotes": [] }, { "id": "fda-drugs-glossary-terms", "title": "Drugs@FDA Glossary of Terms", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official drug-label and approval terminology glossary", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "regulatory-context", "safety-context" ], "notFor": [ "octenidine-specific clinical claims", "product-specific label instructions", "non-U.S. regulatory conclusions" ], "citationNote": "Supports general U.S. drug-label and approval terminology when exact product claims are kept separate.", "editorialNotes": [] }, { "id": "fda-off-label-use-approved-drugs", "title": "Understanding Unapproved Use of Approved Drugs", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label", "tier": "tier_1_identity_regulatory_safety", "sourceType": "official off-label use explainer", "lastChecked": "2026-05-07", "reviewCadenceMonths": 12, "nextReviewDue": "2027-05-07", "useFor": [ "regulatory-context", "safety-context" ], "notFor": [ "octenidine-specific product advice", "clinical recommendations", "non-U.S. regulatory conclusions" ], "citationNote": "Supports general off-label-use terminology and the distinction between approved labeling and other uses.", "editorialNotes": [] }, { "id": "pubmed-octenidine-search", "title": "PubMed search: octenidine dihydrochloride", "publisher": "National Library of Medicine", "url": "https://pubmed.ncbi.nlm.nih.gov/?term=octenidine+dihydrochloride", "tier": "tier_5_context_only", "sourceType": "literature discovery search", "lastChecked": "2026-05-06", "reviewCadenceMonths": 3, "nextReviewDue": "2026-08-06", "useFor": [ "search-discovery" ], "notFor": [ "article claims without opening and reviewing individual records", "evidence grading", "regulatory claims" ], "citationNote": "Provides a literature discovery route; claim support belongs with the individual reviewed articles rather than the search page.", "editorialNotes": [] } ] }