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
M001 10/14/2022 Antacid Products for Over-the-Counter Human Use View Monograph M001 Details Aluminum Carbonate Gel (Basic), Aluminum Hydroxide, Aluminum Hydroxide-Hexitol, Stabilized Polymer, Aluminum Hydroxide-Magnesium Carbonate, Co-Dried Gel, Aluminum Hydroxide-Magnesium Trisilicate, Co-Dried Gel, Aluminum Hydroxide-Sucrose Powder Hydrated, Aluminum Phosphate, Aluminum Phosphate Gel (In Combination Only), Bicarbonate, Bismuth Aluminate, Bismuth Carbonate, Bismuth Subcarbonate, Bismuth Subgallate, Bismuth Subnitrate, Calcium, Calcium (Mono Or Dibasic Salt), Calcium Carbonate, Calcium Phosphate, Citrate (Containing Active Ingredients: Citrate Ion, As Citric Acid Or Salt), Dihydroxyaluminum Aminoacetate, Dihydroxyaluminum Aminoacetic Acid, Dihydroxyaluminum Sodium Carbonate, Glycine (Aminoacetic Acid), Hydrate Magnesium Aluminate Activated Sulfate, Magaldrate, Magnesium Carbonate, Magnesium Glycinate, Magnesium Hydroxide, Magnesium Oxide, Magnesium Trisilicate, Milk Solids, Dried, Potassium Bicarbonate, Potassium Carbonate, Sodium Potassium Tartrate, Tartrate (Acid Or Salt), Tricalcium Phosphate Antacid 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
M022 10/14/2022 Oral Healthcare Drug Products for Over-the-Counter Human Use View Monograph M022 Details Benzocaine, Benzoin Preparations (Compound Tincture Of Benzoin, Tincture Of Benzoin), Benzoin Tincture, Compound, Benzyl Alcohol, Butacaine Sulfate, Carbamide Peroxide (In Anhydrous Glycerin), Dyclonine Hydrochloride, Elm Bark, Gelatin, Glycerin, Hexylresorcinol, Hydrogen Peroxide, Menthol, Pectin, Phenol, Phenolate Sodium, Potassium Nitrate, Salicyl Alcohol, Sodium Bicarbonate, Sodium Perborate Monohydrate, Zinc Chloride Oral Healthcare N/A