 Drugs requiring guidance
|
|
First-class OTC drugs
|
|
 Designated second-class OTC drugs
|
Inorganic and organic chemicals
|
Aspirin
|
Ethyl aminobenzoate
|
Amorolfine
|
Allylisopropylacetylurea
|
Alminoprofen
|
Benzoic acid
|
 D00038 Benzoic acid (JP18/USP)
D02277 Sodium benzoate (JP18/NF)
|
Ibuprofen
|
Estradiol
|
Estradiol benzoate
|
Ethinylestradiol
|
Ethenzamide
|
Casanthranol
|
Ketoprofen
|
Codeine
|
Cortisone acetate
|
Sasapyrine
|
Salicylamide
|
Salicylic acid
|
Phenyl salicylate
|
Dihydrocodeine
|
Diphenhydramine
|
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
|
Fluticasone propionate
|
Flunisolide
|
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
|
D00038 Benzoic acid (JP18/USP)
D02277 Sodium benzoate (JP18/NF)
|
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
|
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
|
Dried chasteberry extracts
|
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
|
Loxoprofen
|
Loperamide
|
Loratadine
|
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
|
D00038 Benzoic acid (JP18/USP)
|
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
|
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
|
Risk Category of Japanese OTC Drugs