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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
M012 10/14/2022 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use View Monograph M012 Details Brompheniramine Maleate, Camphor, Chlophedianol Hydrochloride, Chlorcyclizine Hydrochloride, Chlorpheniramine Maleate, Codeine, Codeine Phosphate, Codeine Sulfate, Dexbromopheniramine Maleate, Dexchlorpheniramine Maleate, Dextromethorphan, Dextromethorphan Hydrobromide, Diphenhydramine Citrate, Diphenhydramine Hydrochloride, Doxylamine Succinate, Ephedrine, Ephedrine Hydrochloride, Ephedrine Sulfate, Epinephrine, Epinephrine Bitartrate, Guaifenesin, Levmetamfetamine, Menthol, Naphazoline Hydrochloride, Oxymetazoline Hydrochloride (Aqueous), Oxymetazoline Hydrochloride (Jelly), Phenindamine Tartrate, Pheniramine Maleate, Phenylephrine Bitartrate (Effervescent), Phenylephrine Hydrochloride, Propylhexedrine, Pseudoephedrine Hydrochloride, Pseudoephedrine Sulfate, Pyrilamine Maleate, Racephedrine Hydrochloride, Racepinephrine Hydrochloride, Thonzylamine Hydrochloride, Triprolidine Hydrochloride, Xylometazoline Hydrochloride (Aqueous), Xylometazoline Hydrochloride (Jelly) Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic N/A
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
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