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Ingredient ATC Level 1 ATC Level 2 Year Of Switch Country Status Additional Information
Clemastine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1979 Japan OTC
Clotrimazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1980 Japan OTC Liquid, ointment, cream, gel or powder-form spray formulations. 1% in a preparation. Apply 2-3 times a day.
Sucralfate A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1981 Japan OTC Switched as a GI combination drug. Tablets, granules, powder, liquid formulation. 500mg a dose up to three times a day for adults and adolescents 15 years of age and older.
Picosulfate (sodium) A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives 1983 Japan OTC Tablet formulation. Maximum dose 7.5mg per day as sodium picosulfate hydrate for adults and adolescents 15 years of age and over. For children between 11 and 14, maximum dose 4.5mg per day.
Dimemorfan R Respiratory system. Respiratory system R05. Cough and cold preparations 1985 Japan OTC Switched as a combination drug for cough remedies. Maximum 60mg per day for cough and maximum 30mg for cold remedies.
Indomet(h)acin M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1985 Japan OTC Rx under this ATC code. OTC under ATC code M02 (topical use) since 1985, in cream, gel, tape and plaster formulations.
Ibuprofen (oral) M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1985 Japan OTC Tablet, capsule, granule formulations. 150mg a dose, up to three times a day for adults and adolescents 15 years of age and over. Also OTC 200mg tablets or capsules, up to twice a day for adults and adolescents 15 years of age and over. If necessary, a third dose is allowed in 2012.
Hyoscine butylbromide A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders 1987 Japan OTC Tablets, capsules. 10mg per dose up to three times a day as Butylscopolamine bromide for adults and adolescents 15 years of age and over.
Ciclopirox Olamine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1987 Japan OTC Topical liquid formulation, cream. 1%, apply 2-3 times a day.
Cetraxate A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1987 Japan OTC Switched as a GI combination drug. Tablet, granule formulations. 200mg a dose, three times a day for adults and adolescents 15 years of age and over.
Bromhexine R Respiratory system. Respiratory system R05. Cough and cold preparations 1987 Japan OTC Switched as a combination drug for cold remedies. Maximum 12mg per day.
Miconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1987 Japan OTC Cream, liquid formulation. 1%, once a day.
Carbocisteine R Respiratory system. Respiratory system R05. Cough and cold preparations 1988 Japan OTC Switched as a combination drug for cough remedies. Maximum 750mg per day for cough and cold remedies.
Econazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1988 Japan OTC Liquid, ointment, cream or spray formulations. 1% in a preparation. Apply 1-3 times a day.
Loperamide A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents 1989 Japan OTC Capsule, tablet, film formulations. 0.5mg a dose, up to twice a day for adults and adolescents 15 years of age and over.
Meclozine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1990 Japan OTC Alternative name: Mecridine.
Mequitazine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1990 Japan OTC 2mg a dose, twice a day for adults and adolescents 15 years of age and over. The dose increased to 3mg a dose, twice a day for adults and adolescents 15 years of age and over in 2011. Also OTC as cold and rhinitis remedies, 1.33mg a dose, three times a day for adults and adolescents 15 years of age and over.
Ubidecarenone C Cardiovascular system. Cardiovascular system C01. Cardiac therapy 1990 Japan OTC Tablets. 30mg per dose up to three times a day for adults and adolescents 15 years of age and over.
Hydrocortisone (topical) D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1990 Japan OTC Ointment, cream formulations. 0.05% of Hydrocortisone butyl ester in a preparation. Apply several times a day.
Ibuprofen (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1990 Japan OTC Ibuprofen piconol (in the treatment of acne). No product currently registered for ibuprofen topical application.
Tioconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1991 Japan OTC
Prednisolone D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1992 Japan OTC Ointment, cream formulations. 0.15% of Prednisolone valerate acetate ester in a preparation. Apply several times a day.
Bifonazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1993 Japan OTC Topical liquid formulation, cream, gel or spray. 1% in a preparation. Apply once a day.
Oxiconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1993 Japan OTC Liquid and gel formulations. 1% in a preparation. Apply once a day.
Sulconazole nitrate (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1993 Japan OTC
Ketoprofen (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1994 Japan OTC 3% cream, lotion gel formulations. Apply up to 4 times a day in adults and adolescents 15 years of age and over. 0.3% gel patches, up to twice a day in adults and adolescents 15 years of age and over.
Piroxicam (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1994 Japan OTC 0.5% liquid, cream or hard gel formulations. Apply 3-4 times a day in adults and adolescents 15 years of age and over.
Oxetacaine N Nervous system. Nervous system N01. Anesthetics 1995 Japan OTC For stomach aches. Tablets: 5mg per dose, up to 3 times a day, in adults and adolescents 15 years of age and over. Allow 4 hours between intakes.
Felbinac (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1995 Japan OTC 3% liquid, gel, hard gel formulations. Apply 2-4 times a day in adults and adolescents 15 years of age and over. 0.7% gel patches or 5% plasters, twice a day in adults.
Cromoglicic acid R Respiratory system. Respiratory system R01. Nasal preparations 1997 Japan OTC For nasal sprays and eye drops. Also OTC under ATC code S01. Nasal spray: 1%, 3-5 times a day. Eye drops: 1%, 4-6 times a day. Restricted to adult use (age 18 years and over).
Ranitidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1997 Japan OTC Tablets. 63mg per dose up to twice a day for adults and adolescents 15 years of age and over. Discontinued.
Famotidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1997 Japan OTC Tablets, powder, liquid formulation. 10mg per dose up to twice a day for adults and adolescents 15 years of age and over.
Cimetidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1997 Japan OTC Tablets, micro granules. 100mg per dose up to three times a day for adults and adolescents 15 years of age and over.
Minoxidil (topical) D Dermatologicals. Dermatologicals D11. Other dermatological preparations 1999 Japan OTC Immediate OTC sale in 1999 (no switch from Rx). 1% liquid formulation for men since 1999. Also 1% for women since 2005. Maximum strength 5% for men since 2009.
Nicotine (gum) N Nervous system. Nervous system N07. Other nervous system drugs 2001 Japan OTC 2mg/unit. Use 4-12 units a day in initial stage, then adjust the dose up to 24 units per day.
Pseudoephedrine R Respiratory system. Respiratory system R01. Nasal preparations 2002 Japan OTC Pseudoephedrine (oral) is available from 2002. For rhinitis remedies, maximum dose 180mg per day. For cold remedies, 135mg per day.
Butenafine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2002 Japan OTC Topical liquid formulation, cream, gel, spray or powder-form spray. 1% in a preparation. Apply once a day.
Amorolfine (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2002 Japan OTC Cream, liquid formulation. 0.5%. Apply once a day.
Terbinafine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2002 Japan OTC Cream, liquid formulation. 1%, once a day.
Neticonazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2002 Japan OTC OTC under ATC code D01 and G01.
Nizatidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 2005 Japan OTC Tablets, capsules, liquid formulation. 75mg a dose up to twice a day for adults and adolescents 15 years of age and over.
Ketotifen R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2006 Japan OTC 1mg a dose, twice a day for adults and adolescents 15 years of age and over. Also OTC as nasal drops under ATC code R01 since 2005 and as 0.05% allergy eye drops under ATC code S01 since 2007.
Ambroxol R Respiratory system. Respiratory system R05. Cough and cold preparations 2007 Japan OTC Switched as a combination drug for cold remedies. 45mg per day.
Aciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 2007 Japan OTC Switched in 2007 for recurrent herpes mouth ulcers. Distribution restricted to pharmacies following an initial doctor consultation. 5% cream, ointment formulations. Apply 3-5 times a day.
Nicotine (patch) N Nervous system. Nervous system N07. Other nervous system drugs 2008 Japan OTC 17.5 or 35mg per a patch. Apply once a day.
Emedastine fumarate R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2008 Japan OTC 1mg a dose, twice a day for adults and adolescents 15 years of age and over. Discountinued.
Miconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 2008 Japan OTC Vaginal tablet. Daily dose 100mg. 1% cream for exrternal use of vulvar candidiasis, 2-3 times a day.
Flavoxate hydrochloride G Genito urinary system and sex hormones. Genito urinary system and sex hormones G04. Urologicals 2008 Japan OTC Oral drug for frequent urination. 200mg a dose, 3 times a day.
Isoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2008 Japan OTC Cream formulation. 1% in a preparation. Apply 2-3 times a day.
Isoconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 2008 Japan OTC Vaginal tablet. Daily dose 100mg. 1% cream for external use of vulvar candidiasis, 2-3 times a day.
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