menthol; methyl salicylate: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hisamitsu Pharm Co	SALONPAS	menthol; methyl salicylate	PATCH;TOPICAL	022029	NDA	Hisamitsu Pharmaceutical Co., Inc.	46581-670-01	1 PATCH in 1 POUCH (46581-670-01)	2008-04-25
Hisamitsu Pharm Co	SALONPAS	menthol; methyl salicylate	PATCH;TOPICAL	022029	NDA	Hisamitsu Pharmaceutical Co., Inc.	46581-670-03	3 PATCH in 1 POUCH (46581-670-03)	2008-04-25
Hisamitsu Pharm Co	SALONPAS	menthol; methyl salicylate	PATCH;TOPICAL	022029	NDA	Hisamitsu Pharmaceutical Co., Inc.	46581-670-05	1 POUCH in 1 BOX (46581-670-05) / 5 PATCH in 1 POUCH	2008-04-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 24, 2026

Executive summary: Menthol and methyl salicylate are commodity terpenoid and salicylate actives with multi-source global supply. Key sourcing channels are (1) chemical intermediates derived from mint oils (menthol) and salicylic acid routes or plant-derived oils (methyl salicylate), (2) tolling or fragrance-chemical capacity that also grades into pharma compliance, and (3) specialty API/formulation suppliers offering DMF-backed dossiers and GMP lots for OTC and topical drug products. For most commercial uses, procurement concentrates on suppliers with consistent GMP supply, validated impurity profiles, and established documentation for regulatory submissions.

What companies supply menthol as a pharma-grade active ingredient?

Menthol is widely sold as an API and as a topical active in pain relief products, especially in gel, cream, and patch formats. Supplier sets are dominated by large chemicals and essential-oil processors with pharma compliance capabilities.

Global supplier archetypes for menthol

Mint-oil processors upgrading to purified menthol (often via fractionation and crystallization).
Terpene-focused chemical manufacturers producing menthol and related intermediates under GMP.
API distributors and contract manufacturers packaging or processing menthol into specified grades and impurity ranges for pharma/OTC.

Typical documentation procurement teams request for menthol

GMP manufacturing sites and batch records
CoA including GC impurity panel
Supplier change control and stability data
Regulatory dossier access (DMF/CEP where applicable)
Nitrogen/packaging controls due to volatility and oxidation risk

What companies supply methyl salicylate as an API (pharma-grade active)?

Methyl salicylate is a topical counterirritant used in pain-relief rubs, liniments, and related OTC drug products. Supply is concentrated among chemical manufacturers with salicylate ester capacity and robust QA release for impurity control.

Common methyl salicylate manufacturing routes

Esterification of salicylic acid with methanol (typical industrial route).
Recovery/processing from related aromatic chemical streams where integrated.

Regulatory-relevant quality items for methyl salicylate

Acid value, ester content, and hydrolysis-related impurities
Controlled residual solvents and heavy metals
Color, odor, and melting behavior specs consistent with topical drug grades
Packaging and humidity controls to prevent drift in assay and impurities

How many suppliers exist for menthol and methyl salicylate, and what are the main regions?

Menthol: Supply is global with concentration in regions that have mint oil processing and terpene chemical capacity. Multiple GMP-capable sites exist due to the commodity nature and large OTC footprint.

Methyl salicylate: Supply is also global, led by producers with salicylic acid derivative capacity and established QA for esterification byproducts.

Procurement reality: Even when multiple suppliers are available on paper, qualification is driven by impurity profile match, documentation readiness (DMF access or dossier equivalents), and reliable batch consistency.

What quality standards do suppliers use for pharmaceutical-grade menthol and methyl salicylate?

GMP baseline

Most pharma/OTC suppliers for these actives operate under cGMP systems, with audit packages built around:

traceability and batch genealogy
validated cleaning and contamination control
in-process controls for esterification (methyl salicylate) and fractionation/crystallization (menthol)
controlled storage due to volatility and oxidation (menthol)

Compendial and internal specs

Menthol and methyl salicylate are commonly aligned to pharmacopoeial grade expectations (USP/EP style) for topical actives
Supplier internal specs often tighten impurity limits beyond compendial baselines to reduce formulation drift

Which suppliers offer DMF/CEP-style regulatory support for menthol and methyl salicylate?

Regulatory support for these commodity actives is usually provided through:

DMF submission access for relevant manufacturing sites
CEP certificates in jurisdictions where used
Quality agreements tied to specific sites and CoA formats

In practice, teams prioritize suppliers that can lock:

the exact manufacturing site(s)
the exact grade/spec sheet
the impurity profile range
change notification timelines

How do menthol and methyl salicylate supplier choices change by dosage form (gel, cream, patch)?

Topical gel/cream

tighter impurity control to avoid odor and color drift
consistent assay for uniform viscosity and dosing uniformity

Patch systems

supplier consistency matters because volatilization rate influences active loading and migration
packaging compatibility and headspace controls may be required in release testing

Roll-on/liniment

fragrance and organoleptic profile become more sensitive to minor impurity shifts

What supplier risks exist for these commodity actives?

Supply-chain and technical

seasonal volatility for menthol (mint yields and oil fractionation throughput)
esterification feedstock price swings (salicylic acid, methanol) for methyl salicylate
impurity drift across sites after equipment upgrades

Regulatory and compliance

audits tied to new or reactivated plants
documentation gaps if a supplier sells the same commodity grade in non-pharma markets
inability to provide traceability for specific batch lots

How do menthol and methyl salicylate supplier costs typically behave?

Menthol: costs track mint oil supply and purification margins; volatility rises when oil supply tightens.
Methyl salicylate: costs track salicylic acid and methanol pricing and esterification capacity utilization.

Procurement strategy often prioritizes multi-sourcing with fixed qualification, then uses framework pricing or tiered contracts to manage spot swings.

What contract manufacturing and tolling options exist for menthol and methyl salicylate?

Many global suppliers offer:

toll purification or fractionation to a tighter impurity envelope
custom packaging (drums, lined fiber, sealed containers) with controlled headspace
QA release with standardized CoA templates

Tolling is typically used when:

formulation teams require specific impurity profiles
a distributor must bridge from chemical bulk supply to pharma-accepted grade

Menthol vs methyl salicylate: how do supplier qualification requirements differ?

Category	Menthol	Methyl salicylate
Main supply driver	Mint oil availability and fractionation throughput	Salicylic acid and methanol pricing, esterification capacity
Volatility risk	Higher	Lower
Key QA focus	Oxidation/impurity stability, organoleptic spec	Acid/ester content, hydrolysis impurities
Packaging sensitivity	Greater due to volatility and oxidation	Moderate
Qualification bottleneck	Impurity profile match across purified grades	Consistent esterification byproduct control

Key takeaways

Menthol and methyl salicylate have broad global sourcing, but pharma/OTC qualification depends on site-specific impurity profiles, GMP documentation readiness, and lot-to-lot consistency.
Menthol supplier selection is more sensitive to seasonal supply dynamics and volatility-related quality controls.
Methyl salicylate supplier selection is more sensitive to esterification feedstock variability and impurity controls tied to hydrolysis and residual solvents.
Multi-sourcing is commercially standard for both actives, paired with tight change control and documented QA release specifications.

FAQs

What CoA tests matter most for menthol pharmaceutical-grade supply?
Typical focus is assay (GC), water/oxidation-related impurities, and impurity panel limits aligned to pharma specs, plus stability/packaging controls.
What impurities in methyl salicylate most often trigger formulation issues?
Hydrolysis-related products and residue levels that affect odor, acid value drift, or stability in topical matrices.
Can fragrance-chemical suppliers be qualified for pharmaceutical menthol and methyl salicylate?
Only if GMP manufacturing, traceability, validated specs, and regulatory dossier support for the specific site and grade are available.
How should contracts be structured for volatile menthol shipments?
Lock specs by grade and site, require headspace/packaging controls, and include change notification and re-test triggers for formulation-critical impurities.
What is the best sourcing approach to manage price volatility for these actives?
Qualify multiple GMP-capable suppliers early, then use tiered procurement or framework pricing tied to agreed spec and audit status.

References

No sources were provided in the prompt to cite specific supplier names, DMFs, or regulatory listings.

Suppliers and packagers for generic pharmaceutical drug: menthol; methyl salicylate