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
- Safety alert: APOHEALTH Paracetamol Pain ReliefIf you've purchased APOHEALTH Paracetamol Pain Relief paracetamol 500 mg film-coated tablets in a bottle, ensure it is kept out of reach of children. This product does not have child-resistant packaging.
- Medicines containing turmeric or curcumin - risk of liver injuryThe TGA has received reports of liver problems experienced by consumers taking medicines containing turmeric or curcumin.
- Metal fragment found in an Ultra Potent-C Chewable TabletBioCeuticals is recalling one Batch 220380 (exp 02/2024) of Ultra Potent-C Chewable (60s) (AUST L 208690) following a consumer report of a metal fragment found in one tablet.
Latest articles
- Warnings on supply and advertising of ‘Haytox’‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG).
- Changes to the regulation of sports supplements in medicinal dosage formsFrom 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG).
How to find out what’s in your medicineWant to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.
Latest publications
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2020The PVIP aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2019In 2019, the TGA conducted 10 pharmacovigilance inspections of Australian medicine sponsors