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Benzocaine | CAS No: 94-09-7 | GMP-certified suppliers
A medication that provides topical local anesthesia for dental procedures, minor trauma, skin irritation, oral pain, and hemorrhoid symptom relief in US and Canadian markets.
Therapeutic categories
Primary indications
- Benzocaine is indicated for local anesthesia in dentistry, minor trauma, and as preparation for infiltrative anesthesia
- Benzocaine products are indicated for topical anesthesia in a wide variety of conditions including skin irritation, oral pain, and hemorrhoids
Product Snapshot
- Benzocaine is available as topical formulations including gels, creams, sprays, ointments, lozenges, and kits for cutaneous, oral, auricular, and mucosal administration
- It is mainly used for local anesthesia in dentistry, minor trauma, skin irritation, oral pain, and hemorrhoids
- Benzocaine products are approved in key regulatory markets including the US and Canada
Clinical Overview
Pharmacodynamically, benzocaine provides local anesthetic effects by binding to voltage-gated sodium channels within nerve cell membranes. This binding inhibits the opening of these channels, blocking sodium ion influx, which is essential for the initiation and propagation of nerve impulses. The result is a reversible loss of nerve signal transmission in the affected area, leading to anesthesia. Benzocaine’s duration of action typically lasts approximately 10 minutes. It exhibits a wide therapeutic window, but precaution is advised due to risks including methemoglobinemia, a potentially serious adverse effect characterized by impaired oxygen delivery. Patients receiving benzocaine-containing products should be informed of this risk.
Absorption of benzocaine through intact skin is relatively limited, consistent with its use as a topical agent. Its metabolism predominantly involves ester hydrolysis, although specifics on systemic ADME parameters are limited due to its primary localized use. Benzocaine is known to interact with several cytochrome P-450 enzymes, including CYP1A2, CYP2B6, CYP2C19, CYP2D6, and CYP2E1, indicating potential for metabolic interactions in systemic exposure contexts.
Safety considerations include avoidance in individuals with known hypersensitivity to ester anesthetics and careful monitoring to prevent methemoglobinemia, especially with prolonged use or application over large surface areas. Benzocaine is classified as an approved active pharmaceutical ingredient in multiple regulatory jurisdictions and is available under various generic and branded over-the-counter topical formulations.
For API procurement, it is essential to source benzocaine with stringent quality control to ensure purity, compliance with pharmacopeial standards, and consistent batch-to-batch performance. The risk of impurities, such as ester hydrolysis products or residual solvents, should be minimized due to their potential impact on safety and efficacy. Verification of manufacturing processes and regulatory certifications supports global supply chain integrity.
Identification & chemistry
| Generic name | Benzocaine |
|---|---|
| Molecule type | Small molecule |
| CAS | 94-09-7 |
| UNII | U3RSY48JW5 |
| DrugBank ID | DB01086 |
Pharmacology
| Summary | Benzocaine acts as a topical anesthetic by reversibly binding to voltage-gated sodium channels (type 10 subunit alpha) in nerve cell membranes, inhibiting sodium ion influx and blocking nerve impulse conduction. This mechanism prevents depolarization and the transmission of pain signals. Benzocaine exhibits a rapid onset of action with a short duration and a wide therapeutic window. |
|---|---|
| Mechanism of action | Benzocaine diffuses into nerve cells where it binds to sodium channels, preventing the channels from opening, and blocking the influx of sodium ions. Nerve cells unable to allow sodium into cells cannot depolarize and conduct nerve impulses. |
| Pharmacodynamics | Benzocaine is indicated for use as a topical anesthetic. It has a duration of action of approximately 10 minutes and a wide therapeutic window. Patients should be counselled regarding the risks of methemoglobinemia. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 10 subunit alpha | Humans | inhibitor |
ADME / PK
| Protein binding | Benzocaine binds to both serum albumin and alpha-1-acid glycoprotein. |
|---|---|
| Metabolism | Benzocaine undergoes ester hydrolysis to form 4-aminobenzoic acid, acetylation to form acetylbenzocaine, or N-hydroxylation to form benzocaine hydroxide. 4-aminobenzoic acid can be acetylated or acetylbenzocaine can undergo ester hydrolysis to form 4-acetaminobenzoic acid. |
Formulation & handling
- Benzocaine is a small molecule anesthetic primarily formulated for topical, oral, and mucosal routes rather than injectable use.
- Its moderate water solubility and LogP suggest suitability for various semi-solid and liquid formulations including gels, creams, and sprays.
- No peptide or biologic stability concerns noted; standard handling precautions for benzoic acid esters apply to maintain purity and prevent hydrolysis.
Regulatory status
| Lifecycle | The API's patent protection in the US and Canada has expired, allowing generic manufacturers to enter the market. As a result, the product is in a mature phase across these regions with established competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for benzocaine involves numerous originator companies and packagers, reflecting a broad network of suppliers predominantly serving the US and Canadian markets. Branded benzocaine products are mainly distributed within these regions, with multiple formulations available. Given widespread availability and product diversity, patent expirations have likely led to existing generic competition in this market. |
|---|
Safety
| Toxicity | Patients experiencing an overdose may present with local anesthetic systemic toxicity syndrome, decreased cardiovascular function, decreased central nervous system function, cardiac arrest, bradycardia, hypotension, cardiac arrhythmias, syncope, and seizures. Patients should be treated with symptomatic and supportive measures which include airway maintenance, controlling seizures, and hemodynamic stabilization. |
|---|
- Benzocaine exposure may lead to systemic toxicity manifesting as cardiovascular and central nervous system depression, including arrhythmias, hypotension, and seizures
- Overdose management requires immediate symptomatic and supportive interventions such as airway maintenance and hemodynamic stabilization
- Handle with care to minimize risk of accidental systemic absorption and toxicity
Benzocaine 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.
Benzocaine API manufacturers & distributors
Compare qualified Benzocaine API suppliers worldwide. We currently have 16 companies offering Benzocaine API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Corden Pharma | Producer | Germany | Italy | CoA, GMP | 45 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Jinzhou Jiutai | Producer | China | China | CoA, USDMF | 3 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Norbrook Labs | Producer | Ireland | Ireland | CoA, USDMF | 6 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Ramdev Chemical | Producer | India | India | CEP, CoA, USDMF, WC | 3 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 757 products |
| THINQ Pharma | Producer | India | India | CoA, FDA | 6 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
When sending a request, specify which Benzocaine 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 Benzocaine 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.
