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Ingredient ATC Level 1 ATC Level 2 Year Of Switch Country Status Additional Information
Paracetamol N Nervous system. Nervous system N02. Analgesics 1955 USA OTC —
Dextromethorphan R Respiratory system. Respiratory system R05. Cough and cold preparations 1958 USA OTC Adult dose 10-20 mg every 4 hours or 30 mg every 6 hours; 120 mg daily maximum
Pseudoephedrine R Respiratory system. Respiratory system R01. Nasal preparations 1976 USA OTC Pseudoephedrine hydrochloride or sulphate. Oral form. Adult dosage is 60mg/4 or 4-6 hours. For hydrochloride, maximum dose is 240mg/24 hours.
Chlorpheniramine (Chlorphenamine) R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1976 USA OTC Chlorpheniramine maleate. Oral form. Adult dosage is 4mg/4-6 hours. In 1981, it received OTC approval for oral time-released form with adult dosage of 12mg/12 hours.
Brompheniramine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1976 USA OTC Brompheniramine maleate. Oral form. Adult dosage is 4mg /4-6 hours.
Dexchlorpheniramine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1976 USA OTC In 1992, dexchlorpheniramine maleate received OTC approval as antihistamine with an adult dosage of 2mg / 4-6 hours (oral).
Oxymetazoline R Respiratory system. Respiratory system R01. Nasal preparations 1976 USA OTC Oxymetazoline hydrochloride. Topical nasal decongestant as 0.05% in aqueous solution. In 1986, oxymetazoline HCl was approved OTC as ocular vasoconstrictor with a dosage of 0.025% solution/drops (topical).
Xylometazoline (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 1976 USA OTC Xylometazoline hydrochloride as topical nasal decongestant with adult dosage as 0.01% in aqueous solution.
Doxylamine succinate R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1978 USA OTC Oral form. Adult dosage is 25mg single dose only (sleep-aid).
Hydrocortisone (topical) D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1979 USA OTC Hydrocortisone or hydrocortisone acetate as antipruritic. Dosages from 0.25 to 0.50%. In 1991, OTC approval for dosages between 0.5% and 1%.
Phenylephrine R Respiratory system. Respiratory system R01. Nasal preparations 1980 USA OTC Nasal decongestant. 10 mg. 1980: Phenylephrine hydrochloride as topical anorectal / vasoconstrictor. Dosage is 0.25%. From 2010, ibuprofen and phenylephrine hydrochloride (200mg ibuprofen + 10mg phenylephrine HCl) is OTC as an analgesic/decongestant.
Ephedrine R Respiratory system. Respiratory system R01. Nasal preparations 1980 USA OTC Ephedrine sulfate as topical anorectal. Dosage is 0.1 to 1.25%. Oral as a bronchodilator.
Diphenhydramine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1981 USA OTC Diphenhydramine hydrochloride as antitussive. Oral form. Adult dosage is 25mg/4 hours. In 1982, diphenhydramide both hydrochloride and monocitrate received OTC approval as sleep aid with a single oral dose of 50mg and 76mg respectively. In 1985, diphenhydramine hydrochloride received OTC approval as antihistamine with an adult dosage of 25-50mg / 4-6 hours (oral). In 1987, it received OTC approval with the same dosage but as antiemetic.
Dexbrompheniramine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1982 USA OTC Dexbrompheniramine maleate as antihistamine. Adult dosage is 6mg/12 hours (oral time-released). In 1985, it received OTC approval with an adult dosage of 2mg/4-6 hours (oral). In 1987, it received OTC approval with an adult dosage of 3mg/6-8 hours (oral).
Trip(r)olidine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1982 USA OTC Triprolidine hydrochloride as antihistamine. Adult dosage is 2.5mg/4-6 hours. In 1985, triprolidine HCl was approved OTC with a dosage of 5mg / 12 hours.
Miconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1982 USA OTC Miconazole nitrate as anticandidal, 4% cream. Three-day vaginal yeast infection treatment switched in 1996.
Haloprogin (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1982 USA OTC Dosage is 1% as topical antifungal.
Dyclonine (oral) N Nervous system. Nervous system N01. Anesthetics 1982 USA OTC Dyclonine hydrochloride as oral anaesthetic. Adult dosage is 0.05 to 0.1% in rinse, mouthwash, gargle or spray, 3-4 times daily. Dosage is 1 to 3mg as lozenge.
Ibuprofen (oral) M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1984 USA OTC Ibuprofen as internal analgesic/antipyretic. Adult dosage is 200mg/4-6 hours. Migraine indication added in 2000. In 1995, ibuprofen suspension received OTC approval as internal analgesic/antipyretic with a paediatric dosage of 7.5mg/kg up to 4 times a day. In 2005, an analgesic sleep aid containing a combination of 400mg ibuprofen + 78mg diphenhydramine citrate or 50mg diphenhydramine hydrochloride was switched to non-prescription status. From 2010, ibuprofen and phenylephrine hydrochloride (200mg ibuprofen + 10mg phenylephrine HCl) is OTC as an analgesic/decongestant.
Pyrantel P Antiparasitic products, insecticides and repellents. Antiparasitic products, insecticides and repellents P02. Anthelmintics 1986 USA OTC Pyrantel embonate.
Chlorphendianol R Respiratory system. Respiratory system R05. Cough and cold preparations 1987 USA OTC Chlorphendianol HCl as antitussive. Adult dosage is 25mg / 6-8 hours (oral).
Loperamide A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents 1988 USA OTC Antidiarrhoeal. Dosage for adults and children 12 and over is 4mg, then 2mg, up to 8mg/day (oral). Children 9-11: 2 mg, up to 6 mg/day. Children 6-8: 2 mg, up to 4 mg/daily
Acetylsalicylic acid N Nervous system. Nervous system N02. Analgesics 1988 USA OTC —
Clotrimazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1989 USA OTC Separate applications for antifungal for athlete's foot or jock itch, and as a vaginal antifungal, 1% lotion and cream, twice daily.
Clotrimazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1990 USA OTC Clotrimazole as anticandidal, 1% cream and 200mg inserts. Original approval in 1990. Strength change in 1996.
Miconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1991 USA OTC Miconazole nitrate as anticandidal, 4% cream. Three-day vaginal yeast infection treatment switched in 1996.
Clemastine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1992 USA OTC Clemastine fumarate as antihistamine. Adult dosage is 1.34mg/12 hours. Same dosage when used in combination with phenylpropanolamine HCl as antihistamine / decongestant.
Naproxen M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1994 USA OTC Naproxen received OTC approval as internal analgesic / antipyretic with an adult dosage of 200mg / 8-12 hours (oral).
Ranitidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1995 USA OTC Heartburn, acid reducer. 150mg dose up to 2 times a day, in adults and adolescents aged 12 and over.
Ketoprofen M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1995 USA OTC Ketoprofen as internal analgesic with a dosage of 12.5mg (lower strength than the Rx version) every 4 to 6 hours.
Butoconazole G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1995 USA OTC Butoconazole nitrate as anticandidal, with a dosage of 2.0% cream and applicators. Three-day treatment for vaginal yeast infections (previously seven-day treatment).
Famotidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1995 USA OTC Heartburn, acid reducer. Adult dosage of 10mg up to 20mg per day. 12 years of age and older.
Cimetidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1995 USA OTC Heartburn, acid reducer. 200mg up to twice a day, in adults and adolescents aged 12 years and over.
Nicotine (patch) N Nervous system. Nervous system N07. Other nervous system drugs 1996 USA OTC One dose (15mg) patch to be used no longer than six weeks. Also in 21mg, 14mg, and 7mg patch series.
Nicotine (gum) N Nervous system. Nervous system N07. Other nervous system drugs 1996 USA OTC 2mg & 4mg.
Nizatidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1996 USA OTC Acid reducer, 75mg up to twice daily, in adults and adolescents aged 12 and over.
Minoxidil (topical) D Dermatologicals. Dermatologicals D11. Other dermatological preparations 1996 USA OTC 2% and 5 % topical solution as hair grower.
Cromoglicic acid R Respiratory system. Respiratory system R01. Nasal preparations 1997 USA OTC Sodium cromoglycate 4% nasal spray for relief and prevention of the nasal symptoms of hay-fever and other nasal allergies in adults and children six years of age and older.
Ketoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1997 USA OTC Shampoo only (1%) to control symptoms of dandruff, psoriasis, and seborrheic dermatitis.
Tioconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1997 USA OTC Tioconazole as a vaginal ointment. Dosage of 6.5% in one-dose treatment.
Terbinafine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1999 USA OTC Only OTC for topical preparations (1%). Tablets remain Rx.
Docosanol (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 2000 USA OTC 10% cream for cold sore / fever blister.
Loratadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2002 USA OTC 10mg/day tablets or syrup antihistamine for hives relief.
Nicotine (sublingual) N Nervous system. Nervous system N07. Other nervous system drugs 2002 USA OTC —
Omeprazole A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 2003 USA OTC Omeprazole 20mg/day acid reducer to treat frequent heartburn. 20mg Omeprazole and 1100mg Sodium bicarbonate to treat frequent heartburn switched to non-prescription status in December 2009.
Macrogol (Polyethylene glycol 3350) A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives 2006 USA OTC Osmotic laxative. 17g powder stirred into a beverage, in adults and adolescents aged 17 and over.
Levonorgestrel G Genito urinary system and sex hormones. Genito urinary system and sex hormones G03. Sex hormones and modulators of the genital system 2006 USA OTC Levornorgestrel 2x0.75mg tablets switched to OTC status for emergency contraception for women over 18 years in August 2006 following a protracted and highly publicised approval process spanning several years. In April 2009 the product became available for women 17 years and over. In July 2009, levonorgestrel 1.5mg switched to OTC status.
Ketotifen R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2006 USA OTC Ketotifen 0.025% ophthalmic solution switched to non-prescription status in 2006.
Cetirizine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2007 USA OTC 5mg and 10mg tablets and chewable tablets, and 1mg/ml (children's syrup) for the temporary relief of symptoms due to hayfever or other respiratory allergies (sneezing, runny nose, itchy or watery eyes, itchy throat or nose). Extended-release tablets containing 5mg cetirizine HCl and 120mg pseudoephedrine HCl for the relief of symptoms due to hayfever or other upper respiratory allergies.
Orlistat A Alimentary tract and metabolism. Alimentary tract and metabolism A08. Antiobesity preparations 2007 USA OTC Orlistat 60 mg capsules up to 3 times per day as a weight loss aid for overweight adults.
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