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You can search all Administrative Orders (Orders) in this list using keyword(s) related to therapeutic categories, ingredients, or dosage form. You can also filter Administrative Orders based on published dates, order types, comment period open, and/or comment due dates.

Order ID Published Date Order Status Order Title Comments Due Date Ingredients Therapeutic Category Dosage Form
OTC000001 09/20/2021 Final Order Over-the-Counter Monograph M002: Antiflatulent Products for Over-the-Counter Human Use N/A Simethicone Antiflatulent N/A
OTC000002 09/20/2021 Final Order Over-the-Counter Monograph M010: Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use N/A Diphenhydramine Citrate, Diphenhydramine Hydrochloride Nighttime Sleep-Aid N/A
OTC000003 09/20/2021 Final Order Over-the-Counter Monograph M014: Topical Otic Drug Products for Over-the-Counter Human Use N/A Carbamide Peroxide (In Anhydrous Glycerin), Isopropyl alcohol 95 percent in an anhydrous glycerin 5 percent base Otic N/A
OTC000004 09/20/2021 Final Order Over-the-Counter Monograph M030: Corn and Callus Remover Drug Products for Over-the-Counter Human Use N/A Salicylic Acid Corn and Callus Remover N/A
OTC000005 09/24/2021 Final Order Over-the-Counter Monograph M016: Skin Protectant Drug Products for Over-the-Counter Human Use N/A 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
OTC000006 09/24/2021 Final Order Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use N/A Aminobenzoic Acid, Avobenzone, Cinoxate, Ensulizole (Phenylbenzimidazole Sulfonic Acid), Homosalate, Meradimate (Menthyl Anthranilate), Octinoxate (Octyl Methoxycinnamate; Ethylhexyl Methoxycinnamate), Octisalate (Octyl Salicylate; Ethylhexyl Salicylate), Octocrylene, Oxybenzone (Benzophenone-3), Padimate O, Sulisobenzone, Titanium Dioxide, Trolamine Salicylate, Zinc Oxide Sunscreen N/A
OTC000007 09/24/2021 Final Order Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses N/A N/A N/A N/A
OTC000008 09/24/2021 Proposed Order Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000009 10/01/2021 Final Order Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use N/A 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
OTC000010 10/01/2021 Final Order Over-the-Counter Monograph M028: Wart Remover Drug Products for Over-the-Counter Human Use N/A Karaya Gum, Salicylic Acid Wart Remover N/A
OTC000011 10/01/2021 Final Order Over-the-Counter Monograph M029: Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use N/A Sodium Sulfide (Aqueous) Ingrown Toenail N/A
OTC000012 10/01/2021 Final Order Over-the-Counter Monograph M031: Pediculicide Drug Products for Over-the-Counter Human Use N/A Piperonyl Butoxide (Combination), Pyrethrum Extract (Combination) Pediculicide N/A
OTC000013 11/23/2021 Final Order Over-the-Counter Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use N/A Benzoyl Peroxide, Resorcinol, Resorcinol Monoacetate (When Combined With Sulfur), Salicylic Acid, Sulfur Acne N/A
OTC000014 11/23/2021 Final Order Over-the-Counter Monograph M009: Antiemetic Drug Products for Over-the-Counter Human Use N/A Cyclizine Hydrochloride, Dimenhydrinate, Diphenhydramine Hydrochloride, Meclizine Hydrochloride Antiemetic N/A
OTC000015 11/23/2021 Final Order Over-the-Counter Monograph M019: Antiperspirant Drug Products for Over-the-Counter Human Use N/A Aluminum Chlorohydrate, Aluminum Chlorohydrex Polyethylene Glycol, Aluminum Chlorohydrex Propylene Glycol, Aluminum Dichlorohydrate, Aluminum Dichlorohydrex Polyethylene Glycol, Aluminum Dichlorohydrex Propylene Glycol, Aluminum Sesquichlorohydrate, Aluminum Sesquichlorohydrate Poylethylene Glycol, Aluminum Sesquichlorohydrate Propylene Glycol, Aluminum Zirconium Octachlorohydrate, Aluminum Zirconium Octachlorohydrex Gly, Aluminum Zirconium Pentachlorohydrate, Aluminum Zirconium Pentachlorohydrex Gly, Aluminum Zirconium Tetrachlorohydrate, Aluminum Zirconium Tetrachlorohydrex Gly, Aluminum Zirconium Trichlorohydrate, Aluminum Zirconium Trichlorohydrex Gly Antiperspirant N/A
OTC000016 11/23/2021 Final Order Over-the-Counter Monograph M026: Deodorant Drug Products for Internal Use for Over-the-Counter Human Use N/A Bismuth Subgallate, Chlorophyllin Copper Complex Internal Deodorant N/A
OTC000017 12/16/2021 Final Order Over-the-Counter Monograph M005: Topical Antifungal Drug Products for Over-the-Counter Human Use N/A Calcium Undecylenate, Clioquinol, Clotrimazole, Copper Undecylenate, Haloprogin, Miconazole Nitrate, Povidone-Iodine, Tolnaftate, Undecylenic Acid, Zinc Undecylenate Antifungal N/A
OTC000018 12/16/2021 Final Order Over-the-Counter Monograph M024: Anthelmintic Drug Products for Over-the-Counter Human Use N/A Pyrantel Pamoate Anthelmintic N/A
OTC000019 12/16/2021 Final Order Over-the-Counter Monograph M025: Cholecystokinetic Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000020 12/16/2021 Final Order Over-the-Counter Monograph M027: Orally Administered Menstrual Drug Products Over-the-Counter Human Use N/A Ammonium Chloride, Caffeine, Pamabrom Menstrual N/A
OTC000021 12/16/2021 Final Order Over-the-Counter Monograph M032: Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use N/A Coal Tar, Pyrithione Zinc, Salicylic Acid, Selenium Sulfide, Selenium Sulfide, Micronized, Sulfur Dandruff, Psoriasis, Seborrheic Dermatitis N/A
OTC000022 04/04/2022 Final Order Over-the-Counter Monograph M008: Antidiarrheal Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000023 04/04/2022 Final Order Over-the-Counter Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000024 10/14/2022 Final Order Over-the-Counter Monograph M001: Antacid Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000025 10/14/2022 Final Order Over-the-Counter Monograph M011: Stimulant Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000026 10/14/2022 Final Order Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000027 10/14/2022 Final Order Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000028 10/14/2022 Final Order Over-the-Counter Monograph M022: Oral Healthcare Drug Products for Over-the-Counter Human Use N/A Benzocaine, Benzyl Alcohol, Butacaine Sulfate, Dyclonine Hydrochloride, Hexylresorcinol, Menthol, Phenol, Salicyl Alcohol Oral Healthcare N/A
OTC000029 10/14/2022 Final Order Over-the-Counter Monograph M023: Poison Treatment Drug Products for Over-the-Counter Human Use N/A Charcoal (Activated), Ipecac Syrup Poison Treatment N/A
OTC000030 05/02/2023 Final Order Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for Over-the-Counter Human Use N/A N/A N/A N/A
OTC000031 05/02/2023 Final Order Over-the-Counter Monograph M004: First Aid Antibiotic Drug Products for Over-the-Counter Human Use N/A N/A Antimicrobial/Antibacterial N/A
OTC000032 05/02/2023 Final Order Over-the-Counter Monograph M007: Laxative Drug Products for Over-the-Counter Human Use N/A N/A Laxative N/A
OTC000033 05/02/2023 Final Order Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use N/A N/A External Analgesic N/A
OTC000034 05/02/2023 Final Order Over-the-Counter Monograph M021: Anticaries Drug Products for Over-the-Counter Human N/A N/A Anticaries N/A
OTC000035 06/14/2024 Proposed Order Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use N/A Acetaminophen Internal Analgesic, Antipyretic,, Antirheumatic N/A
OTC000036 11/08/2024 Proposed Order Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use N/A Phenylephrine Bitartrate (Effervescent), Phenylephrine Hydrochloride Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Liquid, Tablet, Tablet, Effervescent
OTC000037 06/05/2025 Proposed Order Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms N/A N/A N/A N/A
OTC000038 06/05/2025 Proposed Order Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs 10/03/2025 N/A N/A N/A
OTC000039 06/10/2026 Final Order Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information N/A BEMOTRIZINOL Sunscreen BAG ON VALVE SPRAY, CREAM, GEL, LIPSTICK, LOTION, OIL, OINTMENT, PUMP SPRAY, STICK
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