On this page: What is an over-the-counter (OTC) medicine? | How we regulate over-the-counter medicines | Registered over-the-counter medicines | Listed over-the-counter medicines | Further information
What is an over-the-counter (OTC) medicine?
Over-the-counter (OTC) medicines are used mostly for mild health problems. These include:
- aches and pains
- sore throat
- nose congestion
- fungal infection
- upset stomach
Some OTC medicines are available in supermarkets, while others are only available in pharmacies. Some require a conversation with a pharmacist to access.
The risks associated with OTC medicines fall in-between complementary medicines and prescription medicines. They are higher risk and have tighter controls than most complementary medicines, but do not require a prescription.
Most OTC medicines are registered in the Australian Register of Therapeutic Goods (ARTG), while some are listed.
How we regulate over-the-counter medicines
All OTC medicines must be included in the ARTG before they can be sold in Australia.
OTC medicines can be either 'listed' or 'registered' in the ARTG. Listed medicines are generally available off the shelf for a consumer to choose themselves, while registered medicines are higher risk and sometimes only available through a prescription or after consultation with a pharmacist.
You can check whether an OTC medicine is listed or registered by finding the ARTG number on the label. The ARTG number starts with 'AUST' and is followed by 'L' or 'R'. An AUST L means the medicine is listed, while an AUST R number means the medicine is registered.
Read more about the difference between registered and listed medicines on our how we regulate medicines page.
Registered over-the-counter medicines
Registered OTC medicines include higher risk ingredients or make health claims about more serious conditions. Some registered OTC medicines are available off the shelf in supermarkets and health food stores. Others are only sold in pharmacies, or only available from a pharmacist after a consultation.
Because these medicines have more risk, we fully evaluate and confirm the safety, quality and efficacy of these medicines before they go on sale. The sponsoring company must provide robust evidence to support the medicine such as data from human clinical trials. Medicines that use new ingredients or make new health claims receive more scrutiny than medicines similar to ones already on the market.
We continue to monitor these medicines after they go on sale, and if we discover an issue we can suspend or cancel the medicine's registration.
Some examples of registered OTC medicines include mild pain relief medicines and antihistamines.
Listed over-the-counter medicines
Listed OTC medicines only make pre-approved low risk health claims and only contain pre-approved low risk ingredients.
We do not evaluate listed medicines for efficacy before they go on sale, although we may assess efficacy or another aspect of the medicine as part of a post-market review. Medicines that do not comply with regulation may have their listing suspended or cancelled.
Some examples of listed OTC medicines include sunscreens and some toothpastes.
While most sunscreens are regulated as listed (AUST L) over-the-counter therapeutic goods, they are regulated slightly differently. Listed medicines typically can only include low risk ingredients and make low risk health claims. However, we allow sunscreens with certain SPF factors to make high risk claims, such as 'protects against skin cancer' because of the significant role broad spectrum sunscreens play in keeping consumers safe against the Australian sun. For more information, visit our consumer page on sunscreens.