Over-the-counter (OTC) wellness products are supplements, health products, medicines, skincare products, and health aids that consumers can purchase without a doctor’s prescription. They are widely available in community pharmacies, supermarkets, and increasingly through online retailers and online licensed pharmacies.
These products range from everyday pain relief tablets to vitamins, cold and flu remedies, and skincare treatments. Understanding how they are approved, sold, and used safely is essential for businesses that develop them and consumers who buy them.
Types of OTC wellness and pharmaceutical products in Australia
In Australia, there are two main types of OTC products, which can largely be divided between wellness and pharmaceutical products. OTC wellness products are more about prevention, lifestyle, and self-care, while pharmaceutical products target specific medical symptoms or conditions.
Some of the most common OTC categories include:
- Pain relief (paracetamol, ibuprofen, topical creams)
- Cough, cold, and flu medicines
- Allergy and hay fever treatments
- Gastrointestinal aids such as antacids and laxatives
- Nicotine replacement therapy for quitting smoking
- Vitamins, minerals, and dietary supplements
- Antifungal and antibacterial creams
- Sleep aids and mild sedatives
- Sunscreens and therapeutic skincare
These products are designed for everyday, short-term health needs, though consumers are advised to seek pharmacist guidance to ensure safe and appropriate use.
Aromatherapy
Essential oils sold for relaxation or fragrance are cosmetics regulated by AICIS. If therapeutic claims are made, such as relief of anxiety or use as a sleep aid, they must be listed as AUST L medicines.
Baby care (wipes, powders, creams, bath products)
Most baby wipes, bath products, and powders are cosmetics under AICIS. Products for nappy rash or eczema with therapeutic claims are TGA-listed medicines. Baby sunscreens are AUST L-listed medicines.
Cosmeceuticals
Cosmeceuticals blur the line between cosmetics and medicines. If therapeutic claims are made (anti-ageing beyond cosmetic appearance, treatment of skin conditions), they must be listed or registered on the ARTG. Without such claims, they remain regulated as cosmetics by AICIS.
Cosmetics (make-up)
Make-up products (foundations, lipsticks, eye products) are generally classified as cosmetics under AICIS. They are not regulated as medicines unless therapeutic claims are made, such as treating skin conditions. Ingredients must comply with AICIS safety standards.
Feminine hygiene
Most sanitary pads, tampons, and menstrual cups are considered consumer goods and are not regulated as medicines. However, products that make therapeutic claims, such as treatments for thrush or pH-balancing products, are regulated by the TGA as listed medicines.
First aid
The TGA regulates bandages, dressings, wound closures, and similar products as medical devices. Classification depends on the level of risk, with basic dressings being low-risk medical devices and advanced wound care products requiring higher levels of assessment before supply.
Hair care
Shampoos and conditioners are cosmetics regulated by AICIS. Anti-dandruff shampoos with therapeutic claims are TGA-regulated, listed medicines. Hair loss treatments such as minoxidil are medicines and usually classified as Schedule 2 or 3, requiring sale through pharmacies.
Hair dyes
Hair dyes and colouring products are cosmetics regulated by AICIS. They must meet safety standards for ingredients. Warnings about potential allergic reactions are mandatory.
Homeopathy
When therapeutic claims are made, homeopathic products are low-risk listed medicines (AUST L). They must comply with TGA requirements for permitted ingredients and labelling.
Muscle aches and pains
Topical creams and gels with active ingredients like diclofenac and ibuprofen are medicines and often Schedule 2 or 3 pharmacy-only products. Heat rubs without therapeutic claims may be regulated as cosmetics.
Oral care
Toothpastes with fluoride are classified as TGA-listed medicines (AUST L) because they make therapeutic claims about cavity prevention. Whitening toothpastes or cosmetic oral care products without therapeutic claims are regulated as cosmetics by AICIS. Mouthwashes also fall into this split, with therapeutic products listed with the TGA and cosmetic ones regulated under AICIS.
Pet care products
General grooming products are consumer goods or cosmetics under AICIS. Veterinary medicines (such as flea or worming treatments) are regulated by the Australian Pesticides and Veterinary Medicines Authority (APVMA), not the TGA.
Podiatry products
General foot care creams are cosmetics, but antifungal creams are TGA-registered medicines and often pharmacy-only (S2/S3). Insoles and devices are usually unregulated consumer goods unless therapeutic claims are made, in which case they may be regulated as medical devices.
Sleep formulas
Herbal sleep aids (such as valerian and chamomile) are TGA-listed medicines (AUST L). Melatonin is prescription-only in Australia, and stronger sedatives fall under prescription-only schedules.
Skincare
AICIS regulates most skincare products, including cleansers and moisturisers, as cosmetics unless a therapeutic claim is made (such as treating eczema or acne). Products making therapeutic claims are classified as medicines and must be listed or registered with the TGA.
Suncare and tanning products
Primary sunscreens (SPF-rated and therapeutic claims) are regulated by the TGA as listed medicines (AUST L). They must meet strict quality and safety standards. Secondary sunscreens, such as moisturisers with SPF, are classed as cosmetics and regulated by AICIS. Tanning products like bronzers are cosmetics, while “active” tanning accelerators are not permitted for supply in Australia.
Tanning products
Spray tans, bronzers, and self-tanning lotions are considered cosmetics under AICIS. They cannot make therapeutic claims.
Vitamins and supplements
These are usually TGA-listed medicines (AUST L). They must meet standards for quality and safety, but do not need pre-market proof of efficacy. Higher-risk formulations may be registered medicines (AUST R).
Weight loss and protein products
Protein powders and nutritional shakes are regulated as foods under FSANZ (Food Standards Australia New Zealand), unless therapeutic claims are made. Weight loss medicines like orlistat are registered with the TGA and are typically Schedule 3 pharmacy-only.
Differences between OTC wellness products from cosmetics and prescription medicines in Australia
OTC wellness products sit between cosmetics and prescription-only medicines.
- Cosmetics: Regulated mainly by the Australian Competition and Consumer Commission (ACCC). They are intended for appearance, cleansing, or fragrance. They cannot claim to alter body functions or treat disease.
- OTC products: Make therapeutic claims, such as relieving pain, treating heartburn, or reducing hay fever symptoms, but can be sold without a prescription if the risk profile is low.
- Prescription medicines: Higher risk, strictly regulated, and only available through a doctor’s prescription.
Understanding these differences helps brands choose the correct regulatory pathway and consumers make safe purchasing decisions.
How are OTC products regulated in Australia?
In Australia, therapeutic OTC wellness products are overseen by the Therapeutic Goods Administration (TGA). All products must be listed, registered, or included on the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied. Regulation can broadly be grouped into the following categories.
- Listed medicines (AUST L): Low-risk products such as vitamins, minerals, and some herbal supplements. These must meet quality and safety standards and use only permitted ingredients.
- Registered medicines (AUST R): Higher-risk OTC products such as stronger pain relievers, or allergy tablets. These require full scientific evidence of safety, quality and effectiveness.
- Schedule 2 (Pharmacy Medicines): Can be sold in pharmacies without a prescription but require advice from a pharmacist or pharmacy staff.
- Schedule 3 (Pharmacist-Only Medicines): Must be sold under the supervision of a pharmacist, who ensures they are appropriate for the consumer’s needs.
OTC wellness product profiles in Australia are:
- Listed medicines (AUST L): Low-risk products such as vitamins, minerals, herbal supplements, some homeopathic remedies, and most therapeutic sunscreens. These must meet quality and safety standards and use only permitted ingredients.
- Cosmetics (AICIS regulated): Secondary sunscreens and some skincare products that make no therapeutic claims are treated as cosmetics, not medicines, and are regulated separately under the Australian Industrial Chemicals Introduction Scheme.
- Nicotine replacement therapy (S2/S3): Products such as gums, patches, and lozenges are available as Pharmacy Medicines (Schedule 2) or Pharmacist-Only Medicines (Schedule 3) depending on strength and formulation.
- Sleep aids (AUST L): Non-prescription, low-dose herbal or natural remedies are regulated as listed medicines, provided they only use approved low-risk ingredients.
OTC pharmaceutical products profiles in Australia are:
- Registered medicines (AUST R): Higher-risk OTC products such as more potent pain relievers, allergy tablets, and antifungal creams. These require full scientific evidence of safety, quality, and effectiveness before approval.
- Schedule 2 (Pharmacy Medicines): This includes lower-dose pain relief (paracetamol, ibuprofen), many cough and cold medicines, and basic gastrointestinal aids. These can be sold in pharmacies without a prescription but require pharmacist or pharmacy staff advice.
- Schedule 3 (Pharmacist-Only Medicines): This schedule covers stronger formulations, such as codeine-free pain relievers in larger pack sizes, pseudoephedrine-based cold medicines, and some antifungal treatments. These must be sold under the direct supervision of a pharmacist.
This system ensures Australians have safe access to self-care options while maintaining a strong safeguard against misuse.
What do new brands wanting to start out in the OTC wellness space need to consider?
If you are considering developing an OTC wellness product, the process typically involves:
- Classifying the product: Is your product a cosmetic, complementary medicine, or therapeutic good?
- Regulatory approval: Engage with the TGA to understand whether your product requires listing, registration, or inclusion on the ARTG.
- Manufacturing compliance: Use a facility that meets Good Manufacturing Practice (GMP) standards.
- Market positioning: Develop a brand strategy that communicates both compliance and consumer benefits.
- Distribution strategy: Choose the right mix of pharmacy, retail, and online sales channels.
- Distribution partnerships: Work with established OTC distributors who understand the pharmacy channel, regulatory obligations, and consumer expectations.
Working with a specialist OTC wellness product distributor can help streamline compliance, logistics, and retail relationships.
Why is it essential to keep consumers well-informed?
Brand success in the OTC wellness market depends on consumer trust and safety. Clear information on dosage, potential interactions and appropriate use helps ensure safe outcomes while building credibility.
When brands encourage pharmacist consultation and promote responsible use, they support better health decisions, reduce risk and strengthen long-term customer relationships. Transparent labelling, guidance, and education are not only regulatory obligations but also key to positioning a brand as a responsible partner in consumer wellbeing.
Branding and selling OTC products in Australia
Successfully launching an OTC product involves more than just formulation. For businesses entering the OTC wellness market, branding and compliance go hand in hand. Therapeutic claims are tightly regulated, meaning that product labelling, advertising, and packaging must align with TGA and ACCC requirements.
- Evidence-based claims: All marketing statements must be backed by scientific evidence.
- Regulatory compliance: Claims must be accurate and evidence-based to meet TGA advertising and labelling rules.
- Packaging clarity: Packaging should clearly state active ingredients, dosage instructions, and warnings.
- Consumer trust: Brands that emphasise transparency, scientific support, and quality assurance stand out in a competitive market.
- Retail pathways: Products are typically distributed through community pharmacies, health stores or licensed online pharmacies. Some supermarkets also carry OTC wellness items.
- Digital growth: Online pharmacy directories, remote access technology, and even virtual visit services are creating new ways for consumers to access wellness products in Australia.
OTC and wellness products in Australia are carefully regulated to balance safety, access and consumer choice. Understanding how they are classified helps ensure appropriate use and confidence in self-care decisions.
Step up your OTC wellness product strategy.
OTC wellness products are a trusted part of Australian healthcare, providing safe, accessible solutions that consumers rely on every day. For brands, success comes from navigating regulatory requirements, building credibility, and standing out in a competitive market. By combining compliance, clear communication, and strategic distribution, your brand can connect with consumers, drive growth, and make a real impact in the wellness space.
Partner with Rocket Brands – A trusted Australian OTC wellness product distributor
Take your brand to the next level with Rocket Brands. As a trusted Australian OTC wellness product distributor, we help brands navigate TGA compliance, connect with pharmacies, and deliver products safely and efficiently to consumers nationwide.
Whether you’re launching your first wellness product or expanding an existing range, our end-to-end support – from regulatory guidance to national distribution – ensures your brand reaches the right audience with impact and confidence. Contact our team today to start your brand journey and unlock growth in Australia’s retail and pharmacy market.
Frequently Asked Questions
Who is the TGA?
The Therapeutic Goods Administration (TGA) is Australia’s regulator for medicines, medical devices, and some wellness products. It ensures products meet safety, quality, and efficacy standards before being supplied to consumers.
What does the ACCC do?
The Australian Competition and Consumer Commission (ACCC) enforces consumer protection and competition laws. It ensures products are safe, labels are accurate, and businesses operate fairly in the Australian market.
What is Good Manufacturing Practice (GMP)?
GMP sets standards for consistent, safe, and high-quality production of medicines, supplements, and therapeutic goods. Compliance helps brands reduce risks and meet regulatory requirements.
What is the ARTG?
The Australian Register of Therapeutic Goods (ARTG) is the official database of all therapeutic goods approved for sale in Australia. Products must be listed or registered here before they can be supplied.
What does “AICIS regulated” mean?
AICIS (Australian Industrial Chemicals Introduction Scheme) regulates industrial chemicals in cosmetics, hair care, and personal care products, ensuring ingredients are safe and compliant for consumer use.
What are AUST L-listed medicines?
AUST L products are low-risk listed medicines, such as vitamins, minerals, some herbal remedies, and certain sunscreens. They must meet safety and quality standards, but require minimal clinical evidence.
What are AUST R-registered medicines?
AUST R products are higher-risk medicines, including stronger pain relievers and allergy tablets. They must provide full scientific evidence of safety, quality, and effectiveness before approval.
What is FSANZ?
Food Standards Australia New Zealand (FSANZ) develops and monitors food standards, including supplements and fortified foods. It ensures products are safe, properly labelled, and suitable for consumption.
How are OTC products different from cosmetics?
Cosmetics are designed for appearance, cleansing, or fragrance, and cannot claim to treat medical conditions. OTC products, by contrast, are therapeutic goods regulated by the TGA. If a cream claims to “reduce acne” or a lotion claims to “treat eczema,” it will be considered a therapeutic good, not a cosmetic, and must meet stricter approval standards.
Can I buy OTC wellness products online in Australia?
Yes. Licensed Australian pharmacies often operate online stores where you can purchase OTC wellness products, including pain relief, cold and flu remedies, and supplements. It’s important to use reputable, Australian-registered sites that comply with TGA and pharmacy standards, rather than overseas websites, to ensure the products are genuine, safe, and meet local regulations.
Do OTC products have side effects?
Even wellness products, while generally safe, can cause side effects or interact with other supplements or medicines. Brands have a responsibility to provide clear guidance on safe use, recommended dosages, and potential interactions. Transparent labelling, consumer education, and guidance to seek pharmacist or healthcare advice help minimise risk, build trust, and position the brand as a responsible partner in wellbeing. Proper communication around side effects is essential for compliance and long-term customer confidence.
