Over the counter (OTC) medicines
Over the counter (OTC) medicines are sold without a doctor’s prescription and have undergone a full TGA pre-market evaluation of their safety, quality, and efficacy before being supplied in the marketplace.
About over the counter medicines
Over the counter (OTC) medicines have an ‘AUST R’ identification number that must be displayed on the label and packaging.
OTC medicines are most similar to prescription medicines as they contain higher-risk ingredients and make higher-risk indications than registered complementary medicines . Unlike prescription medicines, OTC medicines do not require a prescription to purchase them.
Over the counter (OTC) medicines are used mostly for mild health problems. These include:
- headaches
- aches and pains
- sore throat
- nose congestion
- fever
- fungal infection
- upset stomach
Most OTC medicines are registered in the Australian Register of Therapeutic Goods (ARTG), while some are listed.
Where to buy an OTC medicine
Some OTC medicines can be bought off the shelf from supermarkets and pharmacies while others can be bought after consultation with a pharmacist.
- general sales medicines like paracetamol tablets/capsules in small pack sizes
- pharmacy medicines like esomeprazole tablets/capsules for heartburn and acid reflux
- pharmacist-only medicines like the emergency contraceptive pill.
Supplying an OTC medicine on the Australian market
If you want to supply an OTC medicine on the Australian market, see Supply a non-prescription medicine.
How we ensure OTC medicines are safe
OTC medicines are individually evaluated by the TGA for quality, safety and efficacy before they are supplied in the marketplace.
This means the TGA fully evaluates the medicine (including its ingredients and the indications displayed on the label and other advertising) before it is available to buy on the market.
Reporting a problem with an OTC medicine
If you experience a problem or side effect from an OTC medicine, you should seek advice from a health professional and then report a problem or side effect to the TGA.
Suspicion that a product is fake, dangerous, illegal or misleading
If you think a product might be fake, illegal or the contents on its label, packaging or other advertising (e.g. website, social media or radio) is incorrect or misleading, you can report a breach to the TGA.
Latest alerts
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The oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be given to children under 6 years of age.
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Latest articles
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Promethazine hydrochloride (Phenergan) not to be used in children under 6
Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age. -
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Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.
Latest publications
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The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
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The PVIP aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health
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In 2019, the TGA conducted 10 pharmacovigilance inspections of Australian medicine sponsors