Source registry

Sources used on Octenidine.org

These references help distinguish substance identity, regulatory context, safety information, clinical evidence, product documents, and literature searches.

Last reviewed
2026-05-07
Reviewed by
Octenidine.org Editorial Team

Identity, regulatory, and safety

Octenidine Hydrochloride, CID 51166

Publisher
PubChem, National Library of Medicine
Source type
official chemical substance record
Last checked
2026-05-06
Does not establish
clinical effectiveness claims; product-specific label instructions; jurisdiction-specific approval claims
Supports names, identifiers, structure, formula, synonyms, and links to other official substance records.

Identity, regulatory, and safety

OCTENIDINE HYDROCHLORIDE, UNII U84956NU4B

Publisher
U.S. Food and Drug Administration Global Substance Registration System
Source type
official substance identity record
Last checked
2026-05-06
Does not establish
FDA approval claims; clinical benefit claims; consumer use instructions
Supports UNII, preferred substance name, formula, and synonym mapping. The GSRS page states that UNII availability does not imply regulatory review or approval.

Identity, regulatory, and safety

Octenidine dihydrochloride substance information

Publisher
European Chemicals Agency
Source type
official chemical substance information
Last checked
2026-05-06
Does not establish
human clinical effectiveness; medical product authorization; finished-product directions
Supports EU chemical identity, EC/CAS linkage, and chemical regulatory context when the exact page supports the statement.

Identity, regulatory, and safety

Octenidine dihydrochloride maximum residue limit

Publisher
European Medicines Agency
Source type
official veterinary regulatory assessment page
Last checked
2026-05-06
Does not establish
human antiseptic approval claims; consumer treatment guidance; general efficacy claims
Supports the EMA veterinary maximum-residue-limit context and related regulatory history.

Identity, regulatory, and safety

EU/3/10/755 orphan designation for prevention of late-onset sepsis in premature infants

Publisher
European Medicines Agency
Source type
official orphan designation page
Last checked
2026-05-06
Does not establish
approval or authorization claims; neonatal treatment guidance; evidence of clinical effectiveness
Supports the narrow orphan-designation history and the EMA page's own development-stage language.

Evidence synthesis

Antimicrobial or Antiseptic Cleansers for Wounds

Publisher
NCBI Bookshelf
Source type
health technology evidence report
Last checked
2026-05-06
Does not establish
chemical identity; product label instructions; claims outside wound-cleanser evidence reviewed in the report
Supports cautious wound-care evidence summaries and limitations, including when evidence is mixed or not statistically significant.

Evidence synthesis

Clinical Evidence for the Use of Octenidine Dihydrochloride to Prevent Healthcare-Associated Infections and Decrease Staphylococcus aureus Carriage or Transmission

Publisher
PubMed Central
Source type
peer-reviewed narrative review
Last checked
2026-05-06
Does not establish
clinical recommendations; product substitution guidance; claims outside the reviewed clinical settings
Supports clinical-evidence summaries and discussion of evidence gaps while preserving the review's limitations.

Evidence synthesis

Wound cleansing for treating venous leg ulcers

Publisher
Cochrane
Source type
Cochrane evidence synthesis
Last checked
2026-05-07
Does not establish
wound-care instructions; product-specific label claims; claims outside venous leg ulcer cleansing evidence
Supports cautious venous leg ulcer wound-cleansing evidence limits and uncertainty language.

Evidence synthesis

Antiseptic Agents for Chronic Wounds: A Systematic Review

Publisher
Antibiotics / MDPI
Source type
systematic review
Last checked
2026-05-07
Does not establish
treatment instructions; product rankings; claims outside chronic-wound antiseptic evidence
Supports chronic-wound antiseptic evidence summaries when octenidine limitations and comparator details stay visible.

Primary literature

Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic

Publisher
International Wound Journal / PubMed
Source type
primary randomized controlled trial record
Last checked
2026-05-07
Does not establish
general wound-care recommendations; claims about octenidine dihydrochloride alone; claims outside chronic venous leg ulcers and the studied product context
Supports exact venous leg ulcer study context when formulation, comparator, and outcome limits are retained.

Identity, regulatory, and safety

APPENDIX D TO ยง1910.1200 - SAFETY DATA SHEETS

Publisher
Occupational Safety and Health Administration
Source type
official hazard communication standard appendix
Last checked
2026-05-07
Does not establish
clinical safety claims; supplier quality claims; non-U.S. legal advice or workplace compliance advice
Supports U.S. SDS format and section-structure discussion for hazard communication context.

Identity, regulatory, and safety

Safety precautions and exposure

Publisher
European Chemicals Agency
Source type
official safety data sheet explainer
Last checked
2026-05-07
Does not establish
clinical effectiveness claims; product-specific label claims; supplier selection or procurement advice
Supports plain-language SDS role and workplace hazard communication boundaries.

Identity, regulatory, and safety

Evaluating Health Information

Publisher
MedlinePlus / National Library of Medicine
Source type
official consumer health information guidance
Last checked
2026-05-07
Does not establish
octenidine-specific clinical claims; product label instructions; regulatory status claims
Supports consumer guidance on checking source ownership, purpose, evidence, review, and update dates.

Identity, regulatory, and safety

The Over-the-Counter Drug Facts Label

Publisher
U.S. Food and Drug Administration
Source type
official consumer label-reading guidance
Last checked
2026-05-07
Does not establish
claims that octenidine products are U.S. OTC drugs; product-specific use instructions; clinical effectiveness claims
Supports general U.S. OTC Drug Facts label concepts such as active ingredient, warnings, directions, and other information.

Identity, regulatory, and safety

Calling Poison Help

Publisher
Health Resources and Services Administration
Source type
official U.S. poison-control public guidance
Last checked
2026-05-07
Does not establish
non-U.S. emergency routing; product-specific treatment instructions; clinical safety claims for routine use
Supports U.S.-specific poison-help routing and information to have ready during a poison-center call.

Identity, regulatory, and safety

Talking With Your Doctor

Publisher
MedlinePlus / National Library of Medicine
Source type
official patient communication guidance
Last checked
2026-05-07
Does not establish
octenidine-specific clinical claims; product-specific use instructions; emergency exposure management
Supports patient preparation, question lists, note-taking, and follow-up communication guidance.

Identity, regulatory, and safety

About Questions are the Answer

Publisher
Agency for Healthcare Research and Quality
Source type
official patient engagement guidance
Last checked
2026-05-07
Does not establish
octenidine-specific clinical claims; product-specific use instructions; regulatory status claims
Supports patient question-asking and comprehension language while keeping product-specific advice separate.

Identity, regulatory, and safety

Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps

Publisher
U.S. Food and Drug Administration
Source type
official topical antiseptic product class page
Last checked
2026-05-07
Does not establish
octenidine-specific clinical claims; finished-product directions; claims outside the product and jurisdiction named by the source
Supports general topical antiseptic product-category context while keeping product-specific claims separate.

Identity, regulatory, and safety

Drugs@FDA Glossary of Terms

Publisher
U.S. Food and Drug Administration
Source type
official drug-label and approval terminology glossary
Last checked
2026-05-07
Does not establish
octenidine-specific clinical claims; product-specific label instructions; non-U.S. regulatory conclusions
Supports general U.S. drug-label and approval terminology when exact product claims are kept separate.

Identity, regulatory, and safety

Understanding Unapproved Use of Approved Drugs

Publisher
U.S. Food and Drug Administration
Source type
official off-label use explainer
Last checked
2026-05-07
Does not establish
octenidine-specific product advice; clinical recommendations; non-U.S. regulatory conclusions
Supports general off-label-use terminology and the distinction between approved labeling and other uses.

Literature discovery

PubMed search: octenidine dihydrochloride

Publisher
National Library of Medicine
Source type
literature discovery search
Last checked
2026-05-06
Does not establish
article claims without opening and reviewing individual records; evidence grading; regulatory claims
Provides a literature discovery route; claim support belongs with the individual reviewed articles rather than the search page.