OTC Monographs@FDA
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You can search all OTC Monographs in this list using keyword(s) related to therapeutic category, OTC monograph number (e.g. M001), ingredients, or dosage forms. You can also filter OTC Monographs based on published dates.

OTC Monograph ID Published Date OTC Monograph Title Order History Ingredients Therapeutic Category Dosage Form
M015 10/01/2021 Anorectal Drug Products for Over-the-Counter Human Use View Monograph M015 Details Alcloxa, Aluminum Hydroxide Gel, Benzocaine, Benzyl Alcohol, Calamine, Camphor, Cocoa Butter, Cod Liver Oil, Dibucaine, Dibucaine Hydrochloride, Dyclonine Hydrochloride, Ephedrine Sulfate, Epinephrine, Epinephrine Hydrochloride, Glycerin, Hard Fat, Juniper Tar, Kaolin, Lanolin, Lidocaine, Menthol, Mineral Oil, Petrolatum, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Resorcinol, Shark Liver Oil, Tetracaine, Tetracaine Hydrochloride, Topical Starch, White Petrolatum, Witch Hazel, Zinc Oxide Anorectal N/A
M016 09/24/2021 Skin Protectant Drug Products for Over-the-Counter Human Use View Monograph M016 Details Allantoin, Aluminum Acetate, Aluminum Hydroxide Gel, Aluminum Sulfate, Calamine, Cocoa Butter, Cod Liver Oil, Colloidal Oatmeal, Dimethicone, Glycerin, Hard Fat, Kaolin, Lanolin, Mineral Oil, Petrolatum, Sodium Bicarbonate, Talc, Topical Starch, White Petrolatum, Witch Hazel, Zinc Acetate, Zinc Carbonate, Zinc Oxide Skin Protectant N/A
M018 04/04/2022 Ophthalmic Drug Products for Over-the-Counter Human Use View Monograph M018 Details Carboxymethylcellulose Sodium, Dextran 70, Ephedrine Hydrochloride, Gelatin, Glycerin, Hydroxyethylcellulose, Hypromellose, Lanolin (In Combination), Lanolin, Anhydrous (In Combination), Methylcellulose, Mineral Oil, Mineral Oil, Light, Naphazoline Hydrochloride, Paraffin, Petrolatum, Phenylephrine Hydrochloride, Polyethylene Glycol 300, Polyethylene Glycol 400, Polysorbate 80, Polyvinyl Alcohol, Povidone, Propylene Glycol, Sodium Chloride, Tetrahydrozoline Hydrochloride, Water, Purified, Wax, White, Wax, Yellow, White Ointment, White Petrolatum, Zinc Sulfate Ophthalmic N/A