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Ingredient | ATC Level 1 | ATC Level 2 | Year Of Switch | Country | Status | Additional Information |
---|---|---|---|---|---|---|
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). |
Budesonide (nasal) | R Respiratory system. Respiratory system | R01. Nasal preparations | 2015 | USA | OTC | 32 micrograms per spray. Intranasal steriod for allergic rhinitis. |
Triamcinolone | D Dermatologicals. Dermatologicals | D07. Corticosteroids, dermatological preparations | 2013 | USA | OTC | Rx under ATC code D07 and A01. OTC intranasal steroid for allergic rhinitis. 55 mcg/spray, aqueous suspension. |
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. |
Nicotine (gum) | N Nervous system. Nervous system | N07. Other nervous system drugs | 1996 | USA | OTC | 2mg & 4mg. |
Pyrantel | P Antiparasitic products, insecticides and repellents. Antiparasitic products, insecticides and repellents | P02. Anthelmintics | 1986 | USA | OTC | Pyrantel embonate. |
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. |
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%. |
Minoxidil (topical) | D Dermatologicals. Dermatologicals | D11. Other dermatological preparations | 1996 | USA | OTC | 2% and 5 % topical solution as hair grower. |
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. |
Lidocaine (topical/oral topical) | N Nervous system. Nervous system | N01. Anesthetics | — | USA | OTC | External analgesic or oral health care anesthetic. |
Paracetamol | N Nervous system. Nervous system | N02. Analgesics | 1955 | USA | OTC | — |
Terbinafine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1999 | USA | OTC | Only OTC for topical preparations (1%). Tablets remain Rx. |
Nicotine (sublingual) | N Nervous system. Nervous system | N07. Other nervous system drugs | 2002 | USA | OTC | — |
Fluoride (sodium) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A01. Stomatological preparations | — | USA | OTC | Acidulated phosphate fluoride rinse (dental rinse). Dosage is 0.02% fluoride in aqueous solution (topical). Sodium fluoride rinse (dental rinse). Dosage is 0.05% aqueous solution (topical). Stannous fluoride gel (anti-cavities gel). Dosage is 0.4% gel (topical). Stannous fluoride rinse (dental rinse). Dosage is 0.1% aqueous solution (topical). |
Haloprogin (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1982 | USA | OTC | Dosage is 1% as topical antifungal. |
Tolnaftate | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | USA | OTC | Antifungal |
Tetracycline | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | USA | OTC | First aid ointment. |
Povidone iodine | D Dermatologicals. Dermatologicals | D08. Antiseptics and disinfectants | — | USA | OTC | In 1987, OTC approval for povidone iodine 10% as antimicrobial with a new sponge dosage form. |
Benzoyl peroxide | D Dermatologicals. Dermatologicals | D10. Anti-acne preparations | — | USA | OTC | Acne treatment. |
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. |
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. |
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. |
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. |
Bisacodyl | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | USA | OTC | Laxative. 5mg. In children from 6 to under 12 years of age, dose: 1 tablet. From 12 years and older: 1 to 3 tablets in a single dose. |
Acetylsalicylic acid | N Nervous system. Nervous system | N02. Analgesics | 1988 | USA | OTC | — |
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. |
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. |
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. |
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 |
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. |
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. |
Aluminium hydroxide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | USA | OTC | For the relief of heartburn. |
Selenium | A Alimentary tract and metabolism. Alimentary tract and metabolism | A12. Mineral supplements | — | USA | OTC | Dietary supplement. No authorized OTC medicine indications. |
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. |
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. |
Chlortetracycline (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | USA | OTC | First aid antibiotic ointment. |
Docosanol (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | 2000 | USA | OTC | 10% cream for cold sore / fever blister. |
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. |
Benzalkonium chloride | D Dermatologicals. Dermatologicals | D08. Antiseptics and disinfectants | — | USA | OTC | — |
Calcium carbonate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | USA | OTC | For the relief of heartburn. Maximum daily dose 8g. |
Triclosan | D Dermatologicals. Dermatologicals | D08. Antiseptics and disinfectants | — | USA | OTC | Antigingivits dentifrice. Consumer antiseptic wash indication removed effective September 2017. |
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. |
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). |
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. |
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. |
Tramazoline | R Respiratory system. Respiratory system | R01. Nasal preparations | — | USA | OTC | — |
Selenium sulphide | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | USA | OTC | Anti-dandruff |
Benzocaine | N Nervous system. Nervous system | N01. Anesthetics | — | USA | OTC | — |
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. |
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