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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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