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Ingredient ATC Level 1 ATC Level 2 Year Of Switch Country Status Additional Information
Pholcodine R Respiratory system. Respiratory system R05. Cough and cold preparations — Australia OTC —
Butamirate citrate R Respiratory system. Respiratory system R05. Cough and cold preparations — Australia — No information.
Atovaquone/Proguanil P Antiparasitic products, insecticides and repellents. Antiparasitic products, insecticides and repellents P01. Antiprotozoals — Australia — No information.
Sildenafil G Genito urinary system and sex hormones. Genito urinary system and sex hormones G04. Urologicals — Australia — No information.
Aciclovir (systemic use) J Antiinfectives for systemic use. Antiinfectives for systemic use J05. Antivirals for systemic use — Australia Rx No information.
Adapalene D Dermatologicals. Dermatologicals D10. Anti-acne preparations — Australia — No information.
Dexketoprofen M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products — Australia — No information.
Valaciclovir J Antiinfectives for systemic use. Antiinfectives for systemic use J05. Antivirals for systemic use — Australia Rx No information.
Econazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1997 Australia OTC S4 to S3 switch, for econazole in topical preparations for vaginal use, for treatment of vaginal candidiasis.
Fusafungine R Respiratory system. Respiratory system R02. Throat preparations — Australia — No information.
Ulipristal acetate G Genito urinary system and sex hormones. Genito urinary system and sex hormones G03. Sex hormones and modulators of the genital system 2017 Australia OTC Effective 1st February 2017, S4 to S3 switch for ulipristal when used for emergency post-coital contraception.
Oxitriptan N Nervous system. Nervous system N06. Psychoanaleptics — Australia — No information.
Yohimbine G Genito urinary system and sex hormones. Genito urinary system and sex hormones G04. Urologicals — Australia Rx
Cetrimide D Dermatologicals. Dermatologicals D08. Antiseptics and disinfectants — Australia — No information.
Azelaic acid D Dermatologicals. Dermatologicals D10. Anti-acne preparations — Australia OTC 1996: new Schedule 2 (pharmacy only) entry, azelaic acid in dermal preparations.
Diosmin C Cardiovascular system. Cardiovascular system C05. Vasoprotectives — Australia — No information.
Metronidazole D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use — Australia Rx —
Desloratadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia OTC S2
Antazoline S Sensory organs. Sensory organs S01. Ophthalmologicals — Australia — No information.
Neomycin sulfate D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use — Australia Rx —
Diosmectite A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents — Australia — No information.
Alverine A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders — Australia — No information.
Chlorhexidine A Alimentary tract and metabolism. Alimentary tract and metabolism A01. Stomatological preparations — Australia — Allowed when formulated as a hand wash preparation, at a concentration of 1-2% chlorhexidine gluconate (see OTC monograph). Concentrations above 1% require "Caution" Warning statements.
Chloroxylenol D Dermatologicals. Dermatologicals D08. Antiseptics and disinfectants — Australia — No information.
Isoconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1999 Australia OTC Schedule 3 (pharmacist only, advertising not permitted).
Esomeprazole A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 2013 Australia OTC Switched from S4 (prescription) to S3 (pharmacist only) in 2013. Effective 1 October 2015, approval of Appendix H entry, allowing direct-to-consumer advertising. Effective 1 February 2016, switch from S3 to S2 (pharmacy only) for esomeprazole in 20mg or less per dosage unit for the relief of gastro-oesophageal reflux disease, when in packs containing not more than 7 days' supply.
Trimethoprim J Antiinfectives for systemic use. Antiinfectives for systemic use J01. Antibacterials for systemic use — Australia Rx —
Oxybutynin G Genito urinary system and sex hormones. Genito urinary system and sex hormones G04. Urologicals — Australia Rx —
Lodoxamide S Sensory organs. Sensory organs S01. Ophthalmologicals — Australia — No information.
Guaifenesin R Respiratory system. Respiratory system R05. Cough and cold preparations — Australia OTC General sale (GSL) status in oral liquid preparations containing 2% or less of guaiphenesin; or in divided preparations containing 200mg or less of guaiphenesin per dosage unit. Effective 2009, New S2 (pharmacy only) entry: Guaiphenesin in a modified release dosage form of 1200mg or less of guaiphenesin with a recommended daily dose of 2400mg or less when not labelled for the treatment of children under 12 years of age.
Erdosteine R Respiratory system. Respiratory system R05. Cough and cold preparations — Australia — No information.
Racecadotril A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents — Australia N.R. Not registered or not marketed.
Strontium chloride (toothpaste) Non-classified -. - n. a. — Australia OTC Exempt from scheduling (GSL). Indications: prevention of dental caries, protection against dental hypersensitivity, maintenance of dental hygiene.
Potassium nitrate (toothpaste) Non-classified -. - n. a. — Australia OTC Exempt from scheduling (GSL). Indications: sensitive teeth, enamel protection.
Decaline Non-classified -. - n. a. — Australia N.R. Not registered or not marketed.
Bronopol Non-classified -. - n. a. — Australia N.R. Not registered or not marketed.
Polymyxin B (topical) S Sensory organs. Sensory organs S03. Ophthalmological and otological preparations — Australia Rx —
Chloramphenicol S Sensory organs. Sensory organs S03. Ophthalmological and otological preparations 2009 Australia OTC Chloramphenicol: S4 to S3 for ophthalmic use only (1 May 2010).
Sulfacetamide (topical) S Sensory organs. Sensory organs S01. Ophthalmologicals 1996 Australia OTC S3 in preparations for ophthalmic use containing 10% or less of sulfacetamide (Rx to S3 (1996)).
Trip(r)olidine R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia OTC Effective 1 September 2004, S2 entry changed to require that oral combination preparations include a sympathomimetic decongestant, or that triprolidine is only included in the night component of a day-night pack. This means that the many cough and cold products that do not contain a sympathomimetic decongestant have been switched from S2 to S3. S2 entry: Triprolidine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when: (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant, or (b) in a day-night pack containing triprolidine in the bed-time dose, both except in preparations for the treatment of children two years of age or less. S3 in oral preparations other than those in S2 above. Effective 1 September 2008: S3 to S4 for children under 2 years of age.
Tripelennamine R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia Rx —
Promethazine R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia OTC S2 entry: Promethazine: (a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness, or (b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when: (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant, or (ii) in a day-night pack containing promethazine in the bed-time dose, except in preparations for the treatment of children two years of age or less. Reference to "in oral preparations for the treatment of symptoms of coughs, colds or influenza" removed 1 September 2006. S3 in oral preparations other than those in S2 above.
Oxatomide R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia N.R. Not registered or not marketed.
Mequitazine R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia N.R. Not registered or not marketed.
Mepyramine maleate R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia OTC S3 in oral preparations. S2 for dermal use.
Meclozine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2005 Australia OTC Effective 1 January 2005, small packs of meclozine, when indicated for motion sickness, switched from S4 to S2. S2 entry: Meclozine in primary packs containing 12 or less tablets or capsules of meclozine for the prevention or treatment of motion sickness, except in preparations for the treatment of children under two years of age.
Loratadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia OTC Switched to S3 in 1994. S3 as the only therapeutically active substance in divided preparations for oral use containing 10mg or less of loratadine per dosage unit in a pack containing 10 or less dosage units. In June 1996, liquid preparations were added. From March 1997, the pack size restrictions were no longer applied. From September 1998, combinations with pseudoephedrine as the only other active substance were permitted in preparations containing 5mg or less of loratadine per dose unit. Effective 1999, S3 to S2 switch for loratadine for oral use. Effective 1 September 2012, S2 to GSL switch for loratadine when in primary packs containing no more than 5 dosage units. Effective 1 October 2016, S2 entry amended to increase the GSL loratadine pack size from 5 dosage units to 10 dosage units in divided oral preparations when used in adults and children 12 years of age and over for the treatment of seasonal allergic rhinitis.
Levocetirizine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1997 Australia OTC Effective 1 February 2016, separate Levocetirizine entry in the Poisons Standard (i.e. scheduling is now separate from cetirizine). Levocetirizine entry reads: S2 (pharmacy only) in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when: a) in a primary pack containing not more than 5 days' supply; and b) labelled with a recommended daily dose not exceeding 5mg of levocetirizine. (N.B This means that there is no general sale provision for levocetirizine following the separation of the entries).
Ketotifen R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2009 Australia OTC Ketotifen: S3 to S2 in preparations for ophthalmic use with <0.025% ketotifen (1 May 2009).
Fexofenadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use — Australia OTC Effective 1 September 2011, S2 to GSL status switch in preparations for oral use except in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when: (a) in a primary pack containing 10 dosage units and (b) labelled with a recommended daily dose not exceeding 120mg fexofenadine. Effective 1st February 2017, amendment to the S2 entry to increase the allowable GSL pack size for an exemption from Schedule 2, from 5 days’ supply to 10 days’ supply.
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