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Dyclonine | CAS No: 586-60-7 | GMP-certified suppliers
A medication that provides topical anesthesia on mucous membranes to facilitate oral and airway procedures and offer temporary relief of minor mouth and throat sores.
Therapeutic categories
AnestheticsAnesthetics, LocalCentral Nervous System AgentsCentral Nervous System DepressantsKetonesNervous System
Generic name
Dyclonine
Molecule type
small molecule
CAS number
586-60-7
DrugBank ID
DB00645
Approval status
Approved drug
ATC code
N01BX02
Primary indications
- Used to provide topical anesthesia of accessible mucous membranes prior to examination, endoscopy or instrumentation, or other procedures involving the esophagus, larynx, mouth, pharynx or throat, respiratory tract or trachea, urinary tract, or vagina
- Also used to suppress the gag reflex and/or other laryngeal and esophageal reflexes to facilitate dental examination or procedures (including oral surgery), endoscopy, or intubation
- Also used for relief of canker sores, cold sores or fever blister
Product Snapshot
- Dyclonine is a topical and transmucosal small‑molecule anesthetic supplied in creams, solutions, sprays, gels, lozenges, and related mucosal formulations
- It is used for local anesthesia of accessible mucous membranes and for suppression of gag and laryngeal reflexes during examinations and procedures, as well as for symptomatic relief of minor oral lesions
- It is an approved product in the US and Canada
Clinical Overview
Dyclonine (CAS 586-60-7) is a topical local anesthetic of the alkyl‑phenylketone class used on accessible mucous membranes of the oropharynx, respiratory tract, gastrointestinal tract, genitourinary tract, and selected dermatologic sites. Clinically, it supports procedures such as oral examination, dental interventions, endoscopy, and intubation by suppressing the gag reflex and reducing local sensory responsiveness. It is also used for symptomatic relief of canker sores, cold sores, and fever blisters. Over‑the‑counter products such as Sucrets lozenges and certain Cepacol sprays contain dyclonine for short‑term throat anesthesia.
Pharmacologically, dyclonine produces reversible local anesthesia without loss of consciousness. When applied to mucosal tissues, systemic exposure is usually limited; however, absorption can occur, particularly across inflamed or highly vascular surfaces. Systemic absorption may lead to central nervous system stimulation or depression, consistent with the profile of local anesthetic agents. Cardiovascular effects such as reduced cardiac conduction, decreased excitability, and peripheral vasodilation are possible with significant systemic levels.
The primary mechanism of action involves inhibition of voltage‑gated sodium ion flux across neuronal membranes. By decreasing membrane permeability to sodium, dyclonine stabilizes the neuronal membrane and prevents depolarization. This blocks the initiation and propagation of action potentials in peripheral sensory nerves, producing localized numbness.
Absorption, distribution, metabolism, and excretion parameters for dyclonine are not comprehensively characterized in publicly available sources, but clinical use patterns indicate predominantly local effects with minimal systemic retention when used as directed on intact mucosa.
Safety considerations focus on limiting excessive mucosal application, avoiding use on compromised tissue when systemic uptake may be enhanced, and monitoring for signs of CNS or cardiovascular toxicity if large amounts are applied. Hypersensitivity reactions are uncommon but possible with local anesthetic agents.
For API procurement, sourcing should prioritize established manufacturers with validated processes, impurity control aligned with pharmacopeial expectations for local anesthetic agents, and documentation supporting consistent quality, stability, and regulatory compliance.
Pharmacologically, dyclonine produces reversible local anesthesia without loss of consciousness. When applied to mucosal tissues, systemic exposure is usually limited; however, absorption can occur, particularly across inflamed or highly vascular surfaces. Systemic absorption may lead to central nervous system stimulation or depression, consistent with the profile of local anesthetic agents. Cardiovascular effects such as reduced cardiac conduction, decreased excitability, and peripheral vasodilation are possible with significant systemic levels.
The primary mechanism of action involves inhibition of voltage‑gated sodium ion flux across neuronal membranes. By decreasing membrane permeability to sodium, dyclonine stabilizes the neuronal membrane and prevents depolarization. This blocks the initiation and propagation of action potentials in peripheral sensory nerves, producing localized numbness.
Absorption, distribution, metabolism, and excretion parameters for dyclonine are not comprehensively characterized in publicly available sources, but clinical use patterns indicate predominantly local effects with minimal systemic retention when used as directed on intact mucosa.
Safety considerations focus on limiting excessive mucosal application, avoiding use on compromised tissue when systemic uptake may be enhanced, and monitoring for signs of CNS or cardiovascular toxicity if large amounts are applied. Hypersensitivity reactions are uncommon but possible with local anesthetic agents.
For API procurement, sourcing should prioritize established manufacturers with validated processes, impurity control aligned with pharmacopeial expectations for local anesthetic agents, and documentation supporting consistent quality, stability, and regulatory compliance.
Identification & chemistry
| Generic name | Dyclonine |
|---|---|
| Molecule type | Small molecule |
| CAS | 586-60-7 |
| UNII | 078A24Q30O |
| DrugBank ID | DB00645 |
Pharmacology
| Summary | Dyclonine is a topical local anesthetic that decreases neuronal membrane permeability to sodium ions, blocking initiation and propagation of action potentials. Its primary pharmacologic action is reversible stabilization of nerve membranes through inhibition of voltage‑gated sodium channels, including sodium channel protein type 10 subunit alpha. Systemic absorption can produce CNS stimulation or depression and may depress cardiac conduction and excitability. |
|---|---|
| Mechanism of action | Local anesthetics block both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions. This reversibly stabilizes the membrane and inhibits depolarization, resulting in the failure of a propagated action potential and subsequent conduction blockade. |
| Pharmacodynamics | Dyclonine is an oral anasthetic. If substantial quantities of local anesthetics are absorbed through the mucosa, actions on the central nervous system (CNS) may cause CNS stimulation and/or CNS depression. Actions on the cardiovascular system may cause depression of cardiac conduction and excitability and, with some of these agents, peripheral vasodilation. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 10 subunit alpha | Humans | inhibitor |
ADME / PK
| Absorption | Readily absorbed through mucous membranes into the systemic circulation. The rate of absorption is influenced by the vascularity or rate of blood flow at the site of application, the total dosage (concentration and volume) administered, and the duration of exposure. Absorption from mucous membranes of the throat or respiratory tract may be especially rapid. |
|---|---|
| Half-life | Approximately 30 to 60 minutes. |
Formulation & handling
- Low aqueous solubility (LogP ~3.7) necessitates use of co‑solvents or surfactants for oral sprays, rinses, and topical solutions to ensure adequate solubilization.
- Primarily suited for topical and oral/transmucosal delivery due to local anesthetic action; systemic absorption is limited and not a typical design target.
- Oral/transmucosal formulations should consider transient oral numbness, which can interact with food intake and may influence patient‑handling guidance.
Regulatory status
| Lifecycle | Marketed in the US and Canada, the API is in a mature stage of its lifecycle, with market dynamics largely determined by the timing of patent expiry. As patents expire or approach expiry, these markets typically transition toward increased generic participation and stable, established demand. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dyclonine appears to be supplied primarily by a single listed originator‑level manufacturer, with additional packagers supporting downstream distribution. Branded products are established in the US and Canada, indicating a mature market footprint. The compound is long off patent, suggesting that any generic competition is well established or readily feasible where regulatory frameworks permit. |
|---|
Safety
| Toxicity | Symptoms of overdose include cardiovascular system depression, CNS toxicity, and methemoglobinemia. |
|---|
High Level Warnings:
- Overexposure may elicit cardiovascular depression and CNS toxicity
- Monitor for compound‑related impacts on cardiac conduction and neurologic function during development or scale‑up
- Risk of methemoglobinemia necessitates controls to limit nitrosating conditions and impurities that may elevate oxidative stress potential
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Dyclonine is a type of Local anesthetics
Local anesthetics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) commonly used to numb a specific area of the body during medical procedures or surgeries. They work by blocking the transmission of nerve signals, preventing the sensation of pain in the targeted region. Local anesthetics are vital for various medical applications, including dental procedures, minor surgeries, and childbirth.
The main mechanism of action for local anesthetics involves the reversible inhibition of sodium channels, which are responsible for the conduction of nerve impulses. By binding to these channels, local anesthetics prevent the influx of sodium ions, which blocks the generation and propagation of nerve signals. This results in temporary loss of sensation in the area where the medication is administered.
Local anesthetics can be categorized into two main types: esters and amides. Esters, such as procaine and benzocaine, are metabolized by plasma esterases, while amides, including lidocaine and bupivacaine, undergo hepatic metabolism. The choice of local anesthetic depends on factors such as the duration of action required, the specific procedure being performed, and the patient's medical history.
It is important to note that local anesthetics should be administered with caution, as they can have potential side effects, including allergic reactions, systemic toxicity, and nerve damage if used improperly. Therefore, proper dosage and administration techniques must be followed to ensure patient safety.
In summary, local anesthetics are essential pharmaceutical APIs used to temporarily block nerve signals, providing localized pain relief during medical procedures. Understanding the different types and their mechanisms of action allows healthcare professionals to select the most appropriate local anesthetic for each patient and procedure, ensuring optimal outcomes and patient comfort.
Dyclonine API manufacturers & distributors
Compare qualified Dyclonine API suppliers worldwide. We currently have 5 companies offering Dyclonine API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Changzhou Tianhua | Producer | China | China | CoA, WC | 5 products |
| ChemPacific | Producer | United States | Unknown | CoA, USDMF | 10 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, ISO9001, USDMF | 157 products |
| Shandong Chenghui Shuangd... | Producer | China | China | CoA, ISO9001 | 98 products |
When sending a request, specify which Dyclonine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Dyclonine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Dyclonine API
Sourcing
What matters most when sourcing GMP-grade Dyclonine?
Key considerations include confirming GMP compliance from the originator‑level manufacturer and ensuring packagers maintain equivalent quality controls. Verify that the supplier’s documentation meets U.S. and Canadian regulatory expectations. Because the market is mature and off‑patent, assessing supply reliability and consistency across distribution channels is also important.
Which documents are typically required when sourcing Dyclonine API?
Request the core API documentation set: CoA (5 companies), USDMF (3 companies), ISO9001 (2 companies), WC (1 company), CEP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Dyclonine API?
Known or reported manufacturers for Dyclonine: Senova Technology Co., Ltd., Shandong Chenghui Shuangda Pharmaceutical Co. Ltd., LGM Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Dyclonine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Dyclonine manufacturers?
Audit reports may be requested for Dyclonine: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Dyclonine API on Pharmaoffer?
Reported supplier count for Dyclonine: 5 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Dyclonine API?
Production countries reported for Dyclonine: China (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Dyclonine usually hold?
Common certifications for Dyclonine suppliers: CoA (5 companies), USDMF (3 companies), ISO9001 (2 companies), WC (1 company), CEP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Dyclonine (CAS 586-60-7) used for?
Dyclonine is used as a topical local anesthetic on accessible mucosal surfaces to provide temporary numbness by blocking voltage‑gated sodium channels. It supports procedures such as oral examination, dental work, endoscopy, and intubation by reducing sensory responses and suppressing the gag reflex. It is also used for short‑term symptomatic relief of canker sores, cold sores, fever blisters, and sore‑throat discomfort in over‑the‑counter products.
Which therapeutic class does Dyclonine fall into?
Dyclonine belongs to the following therapeutic categories: Anesthetics, Anesthetics, Local, Central Nervous System Agents, Central Nervous System Depressants, Ketones. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Dyclonine mainly prescribed for?
The primary indications for Dyclonine: Used to provide topical anesthesia of accessible mucous membranes prior to examination, endoscopy or instrumentation, or other procedures involving the esophagus, larynx, mouth, pharynx or throat, respiratory tract or trachea, urinary tract, or vagina, Also used to suppress the gag reflex and/or other laryngeal and esophageal reflexes to facilitate dental examination or procedures (including oral surgery), endoscopy, or intubation, Also used for relief of canker sores, cold sores or fever blister. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Dyclonine work?
Local anesthetics block both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions. This reversibly stabilizes the membrane and inhibits depolarization, resulting in the failure of a propagated action potential and subsequent conduction blockade.
What should someone know about the safety or toxicity profile of Dyclonine?
Dyclonine can cause systemic central nervous system or cardiovascular depression if absorbed in excess, particularly when applied to inflamed or highly vascular tissue. Monitoring for altered cardiac conduction and neurologic effects is advised during development or when large exposures are possible. Overexposure may also increase the risk of methemoglobinemia, so controls that limit nitrosating conditions and related impurities are important. Hypersensitivity reactions are possible but uncommon with topical use.
What are important formulation and handling considerations for Dyclonine as an API?
Dyclonine’s low aqueous solubility requires use of co‑solvents or surfactants to maintain solubility in oral sprays, rinses, and topical solutions. Formulations are typically designed for local topical or oral/transmucosal delivery rather than systemic exposure. Rapid absorption through mucous membranes should be considered when selecting concentration and contact time. Handling guidance should account for transient oral numbness, which can affect patient instructions related to food and drink.
Is Dyclonine a small molecule?
Dyclonine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Dyclonine?
Low aqueous solubility is the primary stability consideration for oral Dyclonine, as maintaining adequate solubilization requires co‑solvents or surfactants. Precipitation can occur if the formulation is not properly designed to keep the drug in solution. No additional stability issues are described in the provided context.
Regulatory
Where is Dyclonine approved or in use globally?
Dyclonine is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Dyclonine right now?
Dyclonine is regulated for use in the United States and Canada. The context does not describe any active patent protections for this ingredient.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Dyclonine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Dyclonine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Dyclonine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Dyclonine: 12 verified transactions across 4 suppliers and 3 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Dyclonine?
Market report availability for Dyclonine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
