Risk Category of Japanese OTC Drugs

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1st Level  2nd Level  3rd Level  4th Level  5th Level 

 Drugs requiring guidance
 
 First-class OTC drugs
 
 Designated second-class OTC drugs
   Inorganic and organic chemicals
     Aspirin
     Ethyl aminobenzoate
     Amorolfine
     Allylisopropylacetylurea
     Alminoprofen
     Benzoic acid
     Ibuprofen
     Estradiol
     Estradiol benzoate
     Ethinylestradiol
     Ethenzamide
     Casanthranol
     Ketoprofen
     Codeine
     Cortisone acetate
     Sasapyrine
     Salicylamide
     Salicylic acid
     Phenyl salicylate
     Dihydrocodeine
     Diphenhydramine
       D00300  Diphenhydramine (JP17/INN)
       D00669  Diphenhydramine hydrochloride (JP17/USP)
     Cerium oxalate
     Sennoside
     Dexamethasone
     Dexamethasone acetate
     Terbinafine
     Triamcinolone acetonide
     Nicotine
     Neticonazole
     Vitamin A oil
     Hydrocortisone
     Hydrocortisone acetate
     Hydrocortisone butyrate
     Ethyl piperidinoacetylaminobenzoate
     Pseudoephedrine
     Butenafine
     Flavoxate
     Fluocinolone acetonide
     Prednisolone
     Prednisolone acetate
     Prednisolone valerate
     Bromovalerylurea
     Promethazine
     Beclometasone dipropionate
     Bethanechol
     Betamethasone valerate
     Methylephedrine
     Rauwolfia serpentina
     Lanoconazole
     Retinol
     Retinol acetate
     Retinol palmitate
     Loperamide
   Crude drugs
 
 Second-class OTC drugs
   Inorganic and organic chemicals
     Acrinol hydrate
     Acitazanolast
     Aspirin
     Acetaminophen
     Azelastine
     Adenosinetriphosphoric acid
     Adrenaline (Epinephrine)
     Ethyl aminobenzoate
     Amorolfine
     Alimemazine
     Allylisopropylacetylurea
     Aldioxa
     Alminoprofen
     Alloclamide
     Benzoic acid
     Ambroxol
     Isothipendyl
     Isopropamide
     Isopropylantipyrine
     Ibuprofen
     Ibuprofen piconol
     Iproheptine
     Indometacin
     Ufenamate
     Exalamide
     Econazole
     Estradiol
     Estradiol benzoate
     Ethanol
     Ethinylestradiol
     Ethyl cysteine
     Ethenzamide
     Ebastine
     Epinastine
     Ephedrine
     Emedastine
     Ergocalciferol or Cholecalciferol
     Oxyquinoline
     Oxiconazole
     Oxytetracycline
     Oxyphencyclimine
     Oxypolyethoxydodecane
     Oxymetazoline
     Oxethazaine
     Kainic acid
     Casanthranol
     Ferric oxide, saccharated
     Carbinoxamine
     Carbocysteine
     Reduced iron
     Guaiacol
     Potassium guaiacolsulfonate
     Ferric ammonium citrate
     Griseofulvin
     Glycerin
     Creosote
     Cresol
     Cresolsulphonate
     Clemastine
     Clotrimazole
     Cloperastine
     Cromoglicic acid
     Chloramphenicol
     Chlorzoxazone
     Chlorphenamine
     Chlorhexidine
     Aluminum silicate
     Magnesium aluminosilicate
     Ketotifen
     Ketoprofen
     Codeine
     Colistin
     Cortisone acetate
     Sasapyrine
     Sanalmin; Aluminum magnesium hydroxide
     Salicylamide
     Salicylated alum powder
     Salicylic acid
     Phenyl salicylate
     Lead oxide
     Santonin
     Sodium hypochlorite
     Diethyldithiocarbamate
     Dioctyl sodium sulfosuccinate
     Dental phenol with camphor
     Ciclopirox olamine
     Diclofenac
     Dichloroisocyanuric acid
     Dicycloverine
     Bismuth subsalicylate
     Bismuth subnitrate
     Bismuth subcarbonate
     Siccanin
     Dihydroxialuminium
     Dihydrocodeine
     Difeterol
     Diphenidol
     Diphenylpiperidinomethyldioxolan iodide
     Diphenylpyraline
     Diphenhydramine
       D00300  Diphenhydramine (JP17/INN)
       D00669  Diphenhydramine hydrochloride (JP17/USP)
       D02419  Diphenhydramine salicylate (JAN)
       D03285  Diphenhydramine tannate (JP17)
     Dibucaine
     Dibunate
     Diprophylline
     Bismuth subgallate
     Dimenhydrinate
     Sodium bromide
     Cerium oxalate
     Magnesia alumina hydrate; Sanalmin
     Aluminum hydroxide
     Aluminum hydroxide - calcium carbonate - magnesium carbonate coprecipitate
     Aluminum hydroxide - sodium bicarbonate coprecipitate
     Aluminum hydroxide - magnesium carbonate
     Potassium hydroxide
     Aluminum hydroxide - aluminum potassium sulfate coprecipitate
     Sucralfate
     Scopolamine
     Sucralfate hydrate - macrogol mixture
     Sulconazole
     Sulfadiazine
     Sulfamine
     Sulfamethoxazole
     Sulfisoxazole
     Sulfisomidine
     Cetirizine
     Cetrimide
     Sennoside
     Sofalcone
     Lead carbonate
     Albumin tannate
     Tioconazole
     Tiquizium
     Tipepidine
     Timepidium bromide
     DEET; N,N-Diethyl-meta-toluamide
     Theobromine
     Dexamethasone
     Dexamethasone acetate
     Dextromethorphan
     Thesit
     Thesit - Desitin
     Tetracycline
     Tetryzoline
     Teprenone
     Demethylchlortetracycline
     Terbinafine
     Tranilast
     Triamcinolone acetonide
     Trichloroisocyanuric acid
     Trichomycin
     Triprolidine
     Tripelennamine
     Trimethylcetylammonium pentachlorophenate
     Trimetoquinol
     Trimebutine
     Tolciclate
     Tolnaftate
     Troxipide
     Thonzylamine
     Nystatin
     Naphazoline
     Nicotine
     Nitrophenol
     Ferrous lactate
     Neticonazole
     Bacitracin
     Papaverine
     Haloprogin
     Picosulfate
     Bisacodyl
     Vitamin A oil
     Aluminum hydroxynaphthoate
     Hydrocortisone
     Hydrocortisone acetate
     Hydrocortisone butyrate
     Hydrotalcite
     Bifonazole
     Piperazine
     Ethyl piperidinoacetylaminobenzoate
     Pyrvinium pamoate
     Pirenzepine
     Pyrrolnitrin
     Piroxicam
     Piroctone olamine
     Ferric pyrophosphate
     Phytonadione
     Phylloquinone
     Fexofenadine
     Pheniramine
     Phenylephrine
     Fenethazine
     Phenol
     Phenol and zinc oxide liniment
     Phenothrin
     Felbinac
     Pseudoephedrine
     Scopolamine butylbromide
     Butenafine
     Bufexamac
     Ferrous fumarate
     Fradiomycin
     Pranoprofen
     Flavoxate
     Fluocinolone acetonide
     Prednisolone
     Prednisolone acetate
     Prednisolone valerate
     Procaine
     Proxyphylline
     Bromhexine
     Bromovalerylurea
     Promethazine
     Hexamine
     Beclometasone dipropionate
     Bethanechol chloride
     Betamethasone valerate
     Heparin sodium
     Heparinoid
     Pemirolast potassium
     Veradoline
     Belladonna extract
     Periphermine
     Berberine
     Pentoxyverine
     Pentoxy pentane
     Homosulfamine
     Polyethylenesulfonate
     Polymyxin B
     Mercurochrome
     Miconazole
     Mequitazine
     Meclizine hydrochloride
     Sodium aluminometasilicate
     Magnesium aluminometasilicate
     Metixene
     Methylatropine
     Anisotropine methylbromide
     Methylephedrine
     Methyloctatropine
     Methyl L-cysteine
     Methylscopolamine
     Hyoscyamine methylbromide
     Methylbenactyzium
     Methocarbamol
     Methoxyphenamine
     Methdilazine
     Mepivacaine
     Mebhydrolin
     Meprylcaine hydrochloride
     Mononitroguaiacol
     Rauwolfia serpentina
     Lactylphenetidine
     Lanoconazole
     Lidocaine
     Lithospermum root
     Cobalt sulfate
     Ferrous sulfate
     Cupric sulfate
     Manganese sulfate
     Resorcin
     Vitamin A
     Retinol acetate
     Retinol palmitate
     Scopolia extract
     Scopolia rhizome
     Loperamide
   Crude drugs
   TCM formulas
   Not used for human
 
 Third-class OTC drugs
   Inorganic and organic chemicals
     Zinc oxide starch powder
     Zinc oxide
     Acrinol hydrate
     Acriflavine
     Acidophilus
     Ascorbic acid
     L-Aspartic acid
     Aspergillus oryzae NK
     Aspergillus oryzae fat digestive enzyme
     Azulene
     Sodium gualenate hydrate
     Ethyl aminobenzoate
     Aminoethylsulfonic acid; Taurine
     Epsilon-Aminocaproic acid
     Amylase
     Amylolisin; Bacillus subtilis amylose digestive enzyme
     L-Alanine
     Allantoin
     Alimemazine
     L-Arginine
     Alkyldiaminoethylglycine hydrochloride
     Alkylpolyaminoethylglycine hydrochloride
     Alcloxa
     Algae colloid
     Aldioxa
     Aloin
     Benzoic acid
     Caffeine and sodium benzoate
     Ammonia solution, strong
     Foeniculated ammonia spirit
     Sulfur
     Ichthammol
     Isothipendyl
     Isopropanol
     L-Isoleucine
     Inositol
     Inositol hexanicotinate
     Ursodeoxycholic acid
     Undecylenic acid
     Ethanol
     Ergocalciferol
     Zinc chloride
     Ammonium chloride
     Potassium chloride
     Calcium chloride
     Sodium chloride
     Eugenol
     Oxycholanic acid
     Oxo amidine
     Oxo resin
     Octotiamine
     Alkylpolyaminoethylglycine - polyoxyethylenealkylphenyl ether mixt
     2-omega-[5'-bromopyridyl-(2')-amino]-vinyl-6-methylpyridine iodine isoamylate
     2-omega-[5'-bromopyridyl-(2')-amino]-vinyl-6-methylpyridine iodine etylate
     gamma Oryzanol
     Olipase
     Orotic acid
     Oxydol
     Gastric mucin
     Anhydrous caffeine
     Capsaicin
     Galactose
     Calamine
     Potash soap
     Carnitine
     Carbazochrome
     Carpronium chloride
     Carmellose
     Dried yeast
     dl-Camphor
     Absorptive ointment
     1,4-Dimethyl-7-isopropylazulene
     Sodium gualenate
     Guaifenesin
     Anhydrous citric acid
     Choline dihydrogen citrate
     Glycine
     Glycerin
     Glycerin and potash solution
     Calcium glycerophosphate
     Glycyrrhizin
     Glycyrrhizin
     Glycyrrhetinic acid
     Cryptocyanine O.A. complex
     Glucuronolactone
     Sodium glucuronate hydrate
     Glucuronamide
     Calcium gluconate
     L-Glutamine
     Glutamic acid
     Crocetin
     Crotamiton
     Chlorohydroxy alminum
     Chlorphenamine
     Chlorophyllin
     Chlorobutanol
     Synthetic aluminum silicate
     Magnesium silicate
     Gefarnate
     Cholic acid
     Choline
     Choline orotate
     Collodion
     Streptococcus faecalis
     Conzym
     Chondroitin sulfate A
     Acetic acid
     Aluminum acetate
     Sacrophyl
     Ethylene glycol salicylate
     Glycol salicylate
     Phenyl salicylate (external use only)
     Methyl salicylate
     Monoglycol salicylate
     Zinc oxide
     Magnesium oxide
     Sancron
     Samprose; Rhizopus chinensis digestive enzyme
     Diastase
     Diasmin
     Cyanocobalamin
     Diisopropylamine dichloroacetate
     Cycotiamine hydrochloride
     Bismuth subnitrate
     Cystine
     L-Cysteine
     Dicethiamine
     Diphenylimidazole
     Diphenylpyraline
     Diphenhydramine
       D00300  Diphenhydramine (JP17/INN)
       D00669  Diphenhydramine hydrochloride (JP17/USP)
       D02419  Diphenhydramine salicylate (JAN)
       D03360  Diphenhydramine laurylsulfate (JAN)
     Dibenzoyl thiamine
     Bismuth subgallate
     Dimeticone
     Dimethylaminoethyl salicylate
     1,4-Dimethyl-7-isopropylazulene
     Dimethylpolysiloxane
     Dimemorfan
     Potassium hydrogen tartrate
     Potassium nitrate
     Hydrophilic ointment
     Calcium hydroxide
     Magnesium hydroxide
     Pancreatic digestive enzyme
     Stearic acid
     Cetylpyridinium
     Camphor soap
     Cetraxate
     Cepharanthine
     Semi-alkaline proteinase
     Gelatin
     Serrapeptase
     Cellulase
     Cellulocin
     Cellulose
     Soysterol
     D-Sorbitol
     Soysterol
     Salivary glands hormone
     Takadiastase
     Talc
     Precipitated calcium carbonate
     Sodium bicarbonate
     Sodium carbonate
     Magnesium carbonate
     Simple ointment
     Tannic acid
     Thiamine
     Thiamine disulfide
     Thiamine dicetylsulfate
     Thianthol
     Thioctic acid
     Thioctic acid amide
     Thymol
     Zinc oxide oil
     Dequalinium chloride
     Dehydrocholic acid
     Sodium dehydroacetate
     Starch
     Amylolytic bacillus
     Copper chlorophyllin
     Tocopherol
     Tocopherol calcium succinate
     Tocopherol acetate
     Domiphen bromide
     Tranexamic acid
     Triclocarban
     Trichlorocarbanilide
     L-Tryptophan
     Tribromophenyl caproate
     L-Threonine
     Tretinoin tocoferil
     Nagarse; Bacillus subtilis protease
     Natto bacillus
     Nicotinic acid
     Nicotinamide
     Benzyl nicotinate
     Lactic acid
     Zinc lactate
     Calcium lactate
     Spore forming lactic acid bacteria
     Newlase
     Urea
     Selenium sulfide
     Neostigmine
     Noscapine
     Nonanoic acid vanillylamide
     White ointment
     White soft sugar
     Platinum
     Palladium
     diethylaminoethyl p-butylaminobenzoate hydrochloride
     L-Valine
     Pancreatin
     Pantethine
     Panthenol
     Pantothenyl ethylether
     Pantothenic acid
     Panprosin
     Hyaluronic acid
     Biotamylase
     Biodiastase; Aspergillus oryzae digestive enzyme
     Biodiasmin
     Biotin
     Bionattomin; Bacillus subtilis digestive enzyme
     Biolactis
     Bisibuthiamine
     Bisthiamine
     L-Histidine
     Bisbentiamine
     Vitamin A oil
     Bithionol
     Pityrol
     Hydroxyethyl cellulose
     Hydroxypropylcellulose
     Hydroxypropylmethyl cellulose
     Hinokitiol
     Bifidobacterium
     Pargyline
     Pyridoxine hydrochloride
     Pyridoxine palmitate
     Pyr methylphenol
     Pyroxylin
     Hylodase
     Phytin
     Streptococcus faecalis
     L-Phenylalanine
     Phenyliodoundecynoate
     Diethyl phthalate
     Sodium fluoride
     Wine
     Glucose
     Flavin adenine dinucleotide
     Fursultiamine
     Prozyme
     Prosultiamine
     Protamylase
     Protease
     Bromelain
     Hespitan
     Hesperidin
     Betaine
     Hepronicate
     Coptis rhizome
     Benzalkonium chloride
     Benzyl alcohol
     Benzethonium chloride
     Benzoylthiamine disulphide
     Benfotiamine
     Boric acid
     Phosphorylcholine
     Povidone-Iodine
     Polyenephosphatidyl choline
     Polipase
     Polyvinyl alcohol
     Polyvinylpyrrolidone
     Polybutene
     Borneol
     Macrogol ointment
     Mamitase
     Water
     Mecobalamin
     Methanol denatured alcohol
     Methionine
     Mthyl isopropylphenol
     Methylcellulose
     Methyl hesperidin
     Methylmethionine sulfonium chloride
     Methylrosanilinium chloride
     Methylthymol tannin
     Methylene blue
     Menthol
     Menfegol
     Pine tar
     Sodium monofluorophosphate
     Morusin
     Organic sulfur containing compound
     Ubidecarenone
     Potassium iodide
     Folic acid
     Iodine
     Yolk lecithin
     Iodine tincture
     Lauryl aminoethyl glycine
     Lauromacrogol
     Clostridium butyricum
     Lactomin
     Lacbon
     Lacb
     Licocymin
     Licorex
     Lysine
     Lysozyme hydrochloride
     Linoleate
     Lipase
     Riboflavin
     Riboflavin butyrate
     Riboflavin sodium phosphate
     Calcium sulfide
     Zinc sulfate
     Aluminum potassium sulfate hydrate
     Sodium sulfate S 35
     Magnesium sulfate hydrate
     Malic acid
     Dibasic calcium phosphate
     Sodium phosphate, dibasic
     Potassium phosphate, monobasic
     Sodium dihydrogen phosphate
     Phospholipid
     Rutin
     Lecithin
     Vitamin A
     Retinol acetate
     Retinol palmitate
     L-Leucine
     Scopolia extract
     Scopolia extract and tannic acid suppositories
     Vaseline
   Crude drugs
OTC drugs that contain as active ingredients the substances listed above including their hydrates and salts
[ DRUG | BRITE | KEGG2 | KEGG ]
Last updated: December 2, 2019
English translation by Kanehisa Laboratories

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