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Levomenthol | CAS No: 2216-51-5 | GMP-certified suppliers
A medication that provides temporary relief of minor throat irritation, cold-related cough, and mild oral or skin discomfort for over‑the‑counter symptomatic formulations.
Therapeutic categories
Primary indications
- Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants
Product Snapshot
- Levomenthol is supplied as a small-molecule ingredient formulated across topical, transdermal, oral, buccal, inhalation, and dental dosage forms
- It is used for products addressing minor irritation, pain, sore mouth or throat, and cough associated with colds or inhaled irritants
- It is approved for use in the United States and Canada
Clinical Overview
Clinically, levomenthol is indicated for the temporary relief of minor throat irritation, cough associated with upper respiratory tract irritation, and mild oral or dermal discomfort. It is incorporated in over‑the‑counter lozenges, inhalation preparations, and topical formulations intended for symptomatic relief.
Pharmacologically, levomenthol induces a cooling sensation when applied to the skin or mucosa or when inhaled. This effect results from activation of TRPM8 cold-sensitive ion channels, producing a perception of coolness without an actual temperature change. Inhibition of neuronal calcium currents contributes to local anesthetic activity. Limited evidence suggests possible engagement of kappa‑opioid receptors, which may support mild analgesic effects, though this is not considered its primary mechanism.
Absorption after topical or oral exposure is variable and depends on formulation and route. Systemic exposure is generally low at typical over‑the‑counter doses. Levomenthol undergoes hepatic biotransformation, primarily through hydroxylation pathways, followed by conjugation and urinary excretion. Detailed quantitative ADME parameters are not well established.
Safety considerations mainly relate to local irritation at high concentrations, potential sensitization in susceptible individuals, and the risk of bronchospasm if excessive inhalation occurs. Systemic toxicity is uncommon at recommended doses. Use in children follows product‑specific restrictions due to the risk of respiratory sensitivity.
Common usage contexts include throat lozenges, cough drops, rubs, liniments, and inhalation aids. Levomenthol is also a flavor and fragrance component, but pharmaceutical applications require compliance with pharmacopeial purity standards.
For API procurement, sourcing should prioritize material meeting relevant pharmacopeial monographs, with attention to enantiomeric purity, residual solvent limits, and control of botanical impurities when plant-derived.
Identification & chemistry
| Generic name | Levomenthol |
|---|---|
| Molecule type | Small molecule |
| CAS | 2216-51-5 |
| UNII | BZ1R15MTK7 |
| DrugBank ID | DB00825 |
Pharmacology
| Summary | Menthol activates TRPM8 receptors to produce a cooling sensation and modulates additional TRP channels and calcium flux, contributing to sensory effects on peripheral neurons. Its interaction with kappa‑opioid receptors may provide mild analgesic activity. These combined actions support its use for transient irritation, minor pain, and cough related to upper airway irritation. |
|---|---|
| Mechanism of action | Menthol primarily activates the cold-sensitive TRPM8 receptors in the skin. Menthol, after topical application, causes a feeling of coolness due to stimulation of 'cold' receptors by inhibiting Ca++ currents of neuronal membranes. It may also yield analgesic properties via kappa-opioid receptor agonism. |
| Pharmacodynamics | Menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol induces a cooling sensation on the skin upon inhalation, oral ingestion, or topical application by stimulating the cold-sensitive receptors expressed on the skin, without actually causing a drop in the skin temperature. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Transient receptor potential cation channel subfamily M member 8 | Humans | inducer |
| Transient receptor potential cation channel subfamily A member 1 | Humans | inducer |
| Transient receptor potential cation channel subfamily V member 3 | Humans | inducer |
Formulation & handling
- Levomenthol is a small, lipophilic monoterpenoid used primarily in topical, inhalation, transmucosal, and oral lozenge formulations, where its low aqueous solubility favors incorporation into oily bases or emulsified systems.
- Its volatility and characteristic odor require controlled handling and tight containment during processing, with attention to evaporation losses in heated or open manufacturing steps.
- For oral and buccal formats, solubility enhancement via solvents, surfactants, or melt-based systems is commonly needed to ensure uniform dispersion and consistent release.
Regulatory status
| Lifecycle | The API remains under patent protection in the US until 2027 and 2030, indicating that market exclusivity is still in place. With commercialization limited to the US and Canada, the product is in a mid‑lifecycle phase, with generic entry expected as patents expire. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Levomenthol is supplied by numerous packagers, indicating a fragmented manufacturing landscape without a single dominant originator company. Branded products are primarily present in the US and Canada across topical and liniment formulations. While levomenthol as an active substance is long established, certain US patents expiring between 2027 and 2030 may still affect specific protected formulations, with broader generic availability otherwise already established. |
|---|
Safety
| Toxicity | Menthol, DL: ORAL (LD50): Acute: 2900 mg/kg [Rat], 3100 mg/kg [Mouse]. DERMAL (LD50): Acute: 5001 mg/kg [Rabbit]. |
|---|
- Moderate acute oral toxicity in rodents, with LD50 values around 2900–3100 mg/kg, indicating the need for controlled handling to limit ingestion exposure
- Low dermal acute toxicity in rabbit studies (LD50 ›5000 mg/kg), though skin contact may still require routine industrial hygiene measures
- Vapors and concentrated forms can act as local irritants, warranting appropriate containment to minimize inhalation and mucosal exposure
Menthol is a type of Herbal remedies
Herbal remedies, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), refer to medicinal products derived from plants. These remedies have been used for centuries in traditional medicine systems across various cultures worldwide. Herbal remedies harness the therapeutic properties of plant materials such as roots, leaves, flowers, and bark to treat a wide range of health conditions.
Herbal remedies are rich in bioactive compounds, including alkaloids, flavonoids, terpenes, and phenolic acids. These compounds exhibit diverse pharmacological activities and can provide benefits for various ailments. They may possess antioxidant, anti-inflammatory, antimicrobial, antiviral, or immunomodulatory properties, among others.
Pharmaceutical companies extensively research and develop herbal remedies to ensure their safety, efficacy, and standardization. The extraction and purification processes involve techniques such as solvent extraction, steam distillation, and chromatography. Quality control measures are implemented to maintain consistency and potency across batches.
Herbal remedies offer a natural alternative to conventional pharmaceutical drugs and are often preferred by individuals seeking holistic or complementary treatment options. They are commonly available in various forms, including capsules, tablets, tinctures, and topical formulations.
It is essential to note that while herbal remedies are generally considered safe, they can still have interactions with other medications and may not be suitable for everyone. Consulting with healthcare professionals or herbalists before starting any herbal treatment is recommended to ensure proper usage and avoid potential adverse effects.
Overall, herbal remedies within the pharmaceutical API subcategory provide a valuable option for individuals seeking natural alternatives and contribute to the growing field of plant-based medicine.
Menthol (Herbal remedies), classified under Others
The others category refers to pharmaceutical APIs that do not fall under specific classifications such as antibiotics, antivirals, analgesics, or cardiovascular drugs. These APIs are diverse in nature and serve various therapeutic purposes, making them a crucial component of pharmaceutical formulations.
Pharmaceutical companies develop APIs in the others category to address specific medical conditions or target novel biological pathways. This category includes APIs used in oncology, neurology, immunology, and other specialized areas of medicine. The APIs in this category are often designed to interact with specific molecular targets or receptors, providing targeted therapeutic effects.
The development of APIs in the others category requires extensive research and testing to ensure their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers employ advanced techniques such as chemical synthesis, biotechnology, and genetic engineering to produce these APIs.
Due to the broad range of applications and therapeutic uses, APIs in the others category contribute significantly to the advancement of medical treatments. Pharmaceutical companies constantly strive to innovate and discover new APIs within this category to address unmet medical needs and improve patient outcomes.
In conclusion, the others category of pharmaceutical APIs encompasses a diverse range of active ingredients used in drug formulation. These APIs play a crucial role in developing innovative therapies across various therapeutic areas, contributing to advancements in healthcare and patient well-being.
Menthol API manufacturers & distributors
Compare qualified Menthol API suppliers worldwide. We currently have 13 companies offering Menthol API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| Anhui Fengle Perfume | Producer | China | China | CoA, WC | 1 products |
| BASF | Producer | Germany | Unknown | CEP, CoA, FDA, GMP, USDMF | 18 products |
| Bhagat Aromatics | Producer | India | India | CoA, GMP, WC | 1 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | France | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | CoA, GMP, ISO9001, MSDS | 170 products |
| Frey & Lau GmbH | Producer | Germany | Unknown | CoA | 5 products |
| Ind-Swift Labs. | Producer | India | India | CoA, FDA, GMP, WC | 27 products |
| NAGAOKA & CO | Producer | Japan | Japan | CoA, USDMF | 2 products |
| Norex Flavours | Producer | India | India | CoA, WC | 2 products |
| Pharm Rx Chemical Corp | Distributor | United States | India | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Sharp Mint | Producer | India | India | CoA, WC | 1 products |
| Symrise AG | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 2 products |
When sending a request, specify which Menthol 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 Menthol 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 Menthol API
Sourcing
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Technical
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Which therapeutic class does LevoMenthol fall into?
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What are important formulation and handling considerations for LevoMenthol as an API?
Is LevoMenthol a small molecule?
Are there special stability concerns for oral LevoMenthol?
Regulatory
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Pharmaoffer
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