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Dimethicone | CAS No: 63148-62-9 | GMP-certified suppliers
A medication that supports skin protection, relieves minor irritation and bloating, and aids head‑lice management for versatile use across pharma and personal care products.
Therapeutic categories
Antifoaming AgentsAntiparasitic Products, Insecticides and RepellentsBasic Ointments and ProtectantsCompounds used in a research, industrial, or household settingEctoparasiticides, Incl. ScabicidesEctoparasiticides, Incl. Scabicides, Insecticides and Repellents
Generic name
Dimethicone
Molecule type
small molecule
CAS number
63148-62-9
DrugBank ID
DB11074
Approval status
Approved drug
ATC code
P03AX05
Primary indications
- Dimethicone is a colorless liquid with both cosmetic and therapeutic uses
- It is used in topical creams and ointments to help distribute the active ingredients
- Dimethicone is used as an anti-foaming agent, a hair and skin conditioner, and in the treatment of head lice and, as an anti-bloating/anti-flatulence agent ,
Product Snapshot
- Dimethicone is formulated mainly as a topical excipient and conditioning agent, with additional oral and topical consumer-health formats
- Its functional uses include anti-foaming activity, skin and hair conditioning, and support in head‑lice and anti‑bloating applications
- It is approved for use in the US and Canada
Clinical Overview
Dimethicone (CAS 63148-62-9) is a polydimethylsiloxane silicone oil with viscoelastic and hydrophobic properties used across pharmaceutical, cosmetic, and industrial applications. In medical and personal care products, it functions as an antifoaming agent, skin protectant, and conditioning excipient. Clinically, dimethicone is incorporated into topical preparations for barrier formation and relief of minor skin irritation. It is also used as a carminative anti‑flatulence agent and as a physical pediculicide in dedicated head‑lice treatments such as NYDA.
Pharmacologically, dimethicone is considered an inert, nonreactive polymer. When applied to skin, it forms a hydrophobic layer that slows transepidermal water loss. This barrier action helps prevent irritation related to moisture exposure, including diaper rash, and reduces chafing or wind‑related skin damage. The compound supports formulation spreadability and can enhance uniform distribution of other topical actives.
The mechanism of action in pediculicidal products is physical rather than neurotoxic. High‑viscosity dimethicone coats lice, nymphs, and eggs, penetrating through spiracles and aeropyles into the tracheal system. Displacement of air and subsequent evaporation of lower‑viscosity components result in occlusion of the respiratory tract and death by suffocation. This non‑chemical mode of action limits the potential for resistance development.
Systemic absorption following topical exposure is expected to be minimal due to the large molecular size and polymeric structure. Dimethicone is generally regarded as having low acute toxicity and low sensitization potential. Reported adverse effects are typically limited to local irritation in sensitive individuals. In pediculicide use, ocular exposure should be avoided due to potential discomfort.
Well‑established usage contexts include over‑the‑counter skin protectants, emollients, hair care formulations, and regulated medical devices requiring controlled surface properties.
For API procurement, suppliers should provide consistent polymer chain length distribution, viscosity specifications, and verification of absence of volatile or low‑molecular‑weight siloxane impurities. Compliance with pharmacopeial monographs and reliable batch‑to‑batch rheological control are essential for pharmaceutical and medical device applications.
Pharmacologically, dimethicone is considered an inert, nonreactive polymer. When applied to skin, it forms a hydrophobic layer that slows transepidermal water loss. This barrier action helps prevent irritation related to moisture exposure, including diaper rash, and reduces chafing or wind‑related skin damage. The compound supports formulation spreadability and can enhance uniform distribution of other topical actives.
The mechanism of action in pediculicidal products is physical rather than neurotoxic. High‑viscosity dimethicone coats lice, nymphs, and eggs, penetrating through spiracles and aeropyles into the tracheal system. Displacement of air and subsequent evaporation of lower‑viscosity components result in occlusion of the respiratory tract and death by suffocation. This non‑chemical mode of action limits the potential for resistance development.
Systemic absorption following topical exposure is expected to be minimal due to the large molecular size and polymeric structure. Dimethicone is generally regarded as having low acute toxicity and low sensitization potential. Reported adverse effects are typically limited to local irritation in sensitive individuals. In pediculicide use, ocular exposure should be avoided due to potential discomfort.
Well‑established usage contexts include over‑the‑counter skin protectants, emollients, hair care formulations, and regulated medical devices requiring controlled surface properties.
For API procurement, suppliers should provide consistent polymer chain length distribution, viscosity specifications, and verification of absence of volatile or low‑molecular‑weight siloxane impurities. Compliance with pharmacopeial monographs and reliable batch‑to‑batch rheological control are essential for pharmaceutical and medical device applications.
Identification & chemistry
| Generic name | Dimethicone |
|---|---|
| Molecule type | Small molecule |
| CAS | 63148-62-9 |
| UNII | 92RU3N3Y1O |
| DrugBank ID | DB11074 |
Pharmacology
| Summary | Dimethicone is a topical, inert silicone polymer that forms a protective occlusive layer on the skin, reducing water loss and shielding against minor irritation. In head lice treatments, its physical properties allow it to penetrate the insects’ respiratory structures, displacing oxygen and causing suffocation across all developmental stages. Its actions are mechanical rather than biochemical, minimizing potential for resistance development. |
|---|---|
| Mechanism of action | When applied topically, dimethicone forms a layer to delay the evaporation of water . In the treatment of head lice dimethicone 100, the respiratory systems of head lice are targeted. NYDA works by suffocating the lice, nymphs and the embryos. The physical properties of this drug, including the viscosity and spreading property of the solution allow it to easily flow into the respiratory system of all developmental stages of the insect, causing suffocation and death of the organisms. It diffuses through the stigmata (spiracles) of the lice, into the tracheae of the head lice as well as through the aeropyles of the egg operculum. The solution then displaces oxygen. The low viscosity, volatile dimethicone enables the NYDA head lice solution to penetrate into the breathing system. Its evaporation causes the thickening of the NYDA solution. The remaining high viscosity dimethicone ultimately encloses the respiratory system and thus leading to suffocation of all stages of head lice (adult lice, larvae and eggs). This mode of action prevents the development of lice resistance by preventing the formation of new progency . Studies performed using house crickets and lice suggest a close correlation between the death of the lice and the influx of the solution into the insect head tracheae. These data strongly suggest that the total filling of the head tracheae immediately blocks the oxygen supply to the insect central nervous system. Death, following numerous stages of disability after the entrance of dimethicones into the abdominal tracheal system, demonstrates the sequence of oxygen deprivation. NYDA was applied directly to the head and mouth of the organism, and was found to have no effect when applied solely to the outside of the head/mouth . |
| Pharmacodynamics | This drug acts as a skin protectant by helping to treat and prevent minor skin irritation due to diaper rash and seals out moisture from the diaper area. This drug temporarily protects and helps prevent chafed, chapped, cracked or windburned skin. . |
ADME / PK
| Absorption | This drug is not believed to be absorbed when used in quantities from 1-30% [FDA label]. |
|---|---|
| Volume of distribution | Following injection of [14C]dimethicone fluid in the hind limb of rats, the radioactivity was distributed primarily in the gastrointestinal tract, and no evidence of metabolism was observed. When [14C]dimethicone was administered through i.p. injection in rats, the following distribution of radioactivity was observed at 25 days after dosing: 51% in adipose tissue, 27% in gastrointestinal tissues, and 15% in liver . |
Formulation & handling
- Used primarily in topical formulations as an inert, hydrophobic silicone that enhances barrier formation and spreadability; not intended for systemic delivery.
- Chemically stable, non‑reactive, and heat tolerant, allowing broad compatibility with emulsions, sticks, ointments, and anhydrous systems without special handling.
- Oral forms use dimethicone as an anti‑foaming agent; its insolubility in water requires suspension or emulsion systems to maintain uniform dispersion.
Regulatory status
| Lifecycle | The API’s primary U.S. patent expired in 2017, indicating that the product is in a mature, post‑exclusivity phase. Availability in the US and Canada suggests it is established in both markets with conditions typical of generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dimethicone is a widely used cosmetic and topical ingredient produced by multiple manufacturers, with no single originator dominating supply. Branded products containing dimethicone are available across North American markets, reflecting broad global use in skin‑care and personal‑care formulations. The cited U.S. patent expired in 2017, indicating that any prior protections have lapsed and that mature, multi‑source generic supply is already established. |
|---|
Safety
| Toxicity | The minimum lethal oral dose of dimethicone 200 (50 cs), dimethicone 550 (75 cs), dimethicone in rats . A 76-week dietary toxicity study of a silicone antifoam compound (94% polydimethylsiloxane silicone oil and 6% silicone dioxide) was performed in mice. Three groups were given diet containing 0, 0.25%, or 2.5% of the test article. The dose levels in the treatment groups were estimated to be 580 and 5800 mg/kg/day. Mortality was increased in the 5800 mg/kg/day females. No target organs of toxicity were observed. The no-effect dose was 580 mg/kg/day. This study is of limited usefulness for assessing the toxicity of dimethicones, due to the small number of organs/tissues that were examined . In one clinical study, 145 subjects were treated with either NYDA (dimethicone )or with a permethrin-based lice product. The number of subjects experiencing any adverse events was similar in both groups. In the NYDA group, 29 adverse events were reported in 25 subjects. All except two adverse events were categorized as being unrelated to the lice treatment (e.g., superficial wound after a fall, otitis externa following swimming in a pool). Two patients in the NYDA group experienced ocular irritation after treatment when the product entered the eyes. The irritation resolved spontaneously in both cases after rinsing the eyes with clean water . |
|---|
High Level Warnings:
- High‑dose dietary exposure in mice (≈5800 mg/kg/day) increased mortality in females, while no target‑organ toxicity was identified
- A no‑effect level of 580 mg/kg/day was reported
- Oral minimum lethal dose data in rats indicate low acute toxicity, though detailed quantitative thresholds are not provided
Polydimethylsiloxane is a type of Excipients
Excipients play a crucial role in the pharmaceutical industry as an essential category of active pharmaceutical ingredients (APIs). These chemical substances, though not intended to have therapeutic effects themselves, are vital components that assist in formulating and manufacturing drugs.
Excipients serve multiple functions in drug formulations. They provide stability, enhance drug solubility, control drug release, improve bioavailability, and facilitate drug administration. Common excipients include binders, disintegrants, lubricants, diluents, colorants, flavors, and preservatives.
Binders are responsible for holding the ingredients together and providing tablet hardness. Disintegrants enable tablets to break down into smaller particles for absorption in the body. Lubricants prevent tablet ingredients from sticking to the manufacturing equipment. Diluents, also known as fillers, increase tablet size and aid in uniformity. Colorants and flavors improve the aesthetic appeal and palatability of oral medications. Preservatives help prevent microbial growth in liquid formulations.
When formulating a drug, excipients must be carefully selected based on their compatibility with the active ingredient, manufacturing process requirements, and regulatory guidelines. Excipients undergo rigorous testing to ensure their safety, stability, and compatibility with the API. Regulatory agencies, such as the U.
S. Food and Drug Administration (FDA), provide guidelines and standards for excipient quality and use.
In conclusion, excipients are indispensable components in pharmaceutical formulations. They contribute significantly to the safety, effectiveness, and overall quality of drugs. Through their varied functions, excipients help optimize drug performance, enhance patient compliance, and ensure the consistent delivery of medications.
Polydimethylsiloxane API manufacturers & distributors
Compare qualified Polydimethylsiloxane API suppliers worldwide. We currently have 6 companies offering Polydimethylsiloxane 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 |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Germany | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Dow Corning Europe | Producer | Belgium | Belgium | CEP, CoA | 2 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | CoA, GMP, ISO9001, MSDS | 170 products |
| Pharm Rx Chemical Corp | Distributor | United States | India | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Riocare India | Producer | India | India | CoA, USDMF | 2 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Polydimethylsiloxane 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 Polydimethylsiloxane 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 Polydimethylsiloxane API
Sourcing
What matters most when sourcing GMP-grade Polydimethylsiloxane?
Key factors include confirming GMP-compliant manufacturing and verifying that the Polydimethylsiloxane grade meets relevant US and Canadian regulatory expectations for topical use. Assess supplier documentation such as specifications, analytical methods, and batch traceability. Given the mature, multi‑source market, consistent quality and reliable supply continuity are also important considerations.
Which documents are typically required when sourcing Polydimethylsiloxane API?
Request the core API documentation set: CoA (6 companies), GMP (4 companies), MSDS (4 companies), BSE/TSE (3 companies), ISO9001 (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Polydimethylsiloxane API?
Known or reported manufacturers for Polydimethylsiloxane: Duchefa Farma B.V., Caesar & Loretz GmbH (CAELO), Pharm Rx Chemical Corp, Tenatra Exports Private Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Polydimethylsiloxane 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 Polydimethylsiloxane manufacturers?
Audit reports may be requested for Polydimethylsiloxane: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Polydimethylsiloxane API on Pharmaoffer?
Reported supplier count for Polydimethylsiloxane: 6 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Polydimethylsiloxane API?
Production countries reported for Polydimethylsiloxane: India (3 producers), Germany (2 producers), Belgium (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Polydimethylsiloxane usually hold?
Common certifications for Polydimethylsiloxane suppliers: CoA (6 companies), GMP (4 companies), MSDS (4 companies), BSE/TSE (3 companies), ISO9001 (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Polydimethylsiloxane (CAS 63148-62-9) used for?
Polydimethylsiloxane is used as a skin‑protective and conditioning excipient in topical products, where it forms a hydrophobic barrier that helps reduce moisture loss and minor irritation. It also functions as an antifoaming agent and as a carminative in anti‑flatulence preparations. In head‑lice treatments, high‑viscosity Polydimethylsiloxane acts as a physical pediculicide by occluding the lice respiratory system.
Which therapeutic class does Polydimethylsiloxane fall into?
Polydimethylsiloxane belongs to the following therapeutic categories: Antifoaming Agents, Antiparasitic Products, Insecticides and Repellents, Basic Ointments and Protectants, Compounds used in a research, industrial, or household setting, Ectoparasiticides, Incl. Scabicides. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Polydimethylsiloxane mainly prescribed for?
The primary indications for Polydimethylsiloxane: Polydimethylsiloxane is a colorless liquid with both cosmetic and therapeutic uses, It is used in topical creams and ointments to help distribute the active ingredients, Polydimethylsiloxane is used as an anti-foaming agent, a hair and skin conditioner, and in the treatment of head lice and, as an anti-bloating/anti-flatulence agent ,. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Polydimethylsiloxane work?
When applied topically, Polydimethylsiloxane forms a layer to delay the evaporation of water .
In the treatment of head lice Polydimethylsiloxane 100, the respiratory systems of head lice are targeted. NYDA works by suffocating the lice, nymphs and the embryos. The physical properties of this drug, including the viscosity and spreading property of the solution allow it to easily flow into the respiratory system of all developmental stages of the insect, causing suffocation and death of the organisms. It diffuses through the stigmata (spiracles) of the lice, into the tracheae of the head lice as well as through the aeropyles of the egg operculum. The solution then displaces oxygen. The low viscosity, volatile Polydimethylsiloxane enables the NYDA head lice solution to penetrate into the breathing system. Its evaporation causes the thickening of the NYDA solution. The remaining high viscosity Polydimethylsiloxane ultimately encloses the respiratory system and thus leading to suffocation of all stages of head lice (adult lice, larvae and eggs). This mode of action prevents the development of lice resistance by preventing the formation of new progency .
Studies performed using house crickets and lice suggest a close correlation between the death of the lice and the influx of the solution into the insect head tracheae. These data strongly suggest that the total filling of the head tracheae immediately blocks the oxygen supply to the insect central nervous system. Death, following numerous stages of disability after the entrance of Polydimethylsiloxanes into the abdominal tracheal system, demonstrates the sequence of oxygen deprivation. NYDA was applied directly to the head and mouth of the organism, and was found to have no effect when applied solely to the outside of the head/mouth .
What should someone know about the safety or toxicity profile of Polydimethylsiloxane?
Polydimethylsiloxane shows low acute toxicity, with rat data indicating a high minimum lethal dose and mouse studies identifying a no‑effect level of 580 mg/kg/day. At markedly higher oral exposures (about 5800 mg/kg/day), increased mortality was observed in female mice, but no specific target‑organ toxicity was identified. Topically, systemic absorption is minimal, and adverse effects are usually limited to mild local irritation. Avoid ocular exposure in pediculicide formulations due to potential discomfort.
What are important formulation and handling considerations for Polydimethylsiloxane as an API?
Polydimethylsiloxane is formulated as an inert, hydrophobic silicone that supports barrier formation and spreadability in topical products, and it is compatible with emulsions, ointments, sticks, and anhydrous systems without special handling. Its chemical stability and heat tolerance allow standard processing conditions. For oral anti‑foaming applications, its water insolubility requires use in suspensions or emulsions to maintain uniform dispersion. Absorption is minimal at typical topical concentrations, so it is generally handled as a non‑systemic ingredient.
Is Polydimethylsiloxane a small molecule?
Polydimethylsiloxane is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Polydimethylsiloxane?
Oral Polydimethylsiloxane is chemically stable and does not require special handling from a reactivity or heat‑stability standpoint. Its main stability consideration is its insolubility in water, which necessitates the use of suspension or emulsion systems to keep the material uniformly dispersed. Proper formulation is needed to prevent phase separation and ensure consistent dosing.
Regulatory
Where is Polydimethylsiloxane approved or in use globally?
Polydimethylsiloxane 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 Polydimethylsiloxane right now?
Polydimethylsiloxane is permitted for use in the United States and Canada in drug and personal‑care products within their respective monograph and ingredient‑listing frameworks. It is treated as a well‑established, non‑proprietary substance. No active patent protections are indicated in the provided context.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Polydimethylsiloxane procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Polydimethylsiloxane. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Polydimethylsiloxane included in the PRO Data Insights coverage?
PRO Data Insights coverage for Polydimethylsiloxane: 195 verified transactions across 59 suppliers and 48 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Polydimethylsiloxane?
Market report availability for Polydimethylsiloxane: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
