Between Sep. 9, 1976 and Aug. 23, 2023, 107 drug ingredients were switched from prescription (Rx) to over-the-counter (OTC) status by the FDA.
Below is a table indicating the ingredient with the adult dosage, brand name examples of the ingredient, the category of drug ingredient, and the date the drug ingredient was switched from prescription to over-the-counter status by the FDA.
Please note that ProCon has not included drugs that were originally OTC and were approved for a new OTC use.
| Ingredient [Adult Dosage] | Brand Name Examples | Drug Category | Date of Rx to OTC Switch |
|---|---|---|---|
| brompheniramine maleate [4 mg/4-6 hours (oral)] | Dimetapp | antihistamine | Sep. 9, 1976 |
| chlorpheniramine maleate [4 mg/4-6 hours (oral)] | Chlor-Trimeton, Coricidin HBP, Triaminic Cold & Allergy | antihistamine | Sep. 9, 1976 |
| oxymetazoline hydrochloride [0.05% aqueous solution (topical)] | Afrin, Neo-Synephrine-12 Hour | nasal decongestant | Sep 9, 1976 |
| pseudoephedrine hydrochloride [60 mg/4 or 4-6 hours (oral) 240 mg max./24 hours] | Sudafed | nasal decongestant | Sep 9. 1976 |
| pseudoephedrine sulfate [60 mg/4 or 4-6 hours (oral)] | Drixoral | nasal decongestant | Sep 9. 1976 |
| xylometazoline hydrochloride [0.01% aqueous solution (topical)] | Natru-Vent | nasal decongestant | Sep. 9, 1976 |
| doxylamine succinate [25 mg single dose only (oral)] | Unisom | sleep-aid | Oct. 18, 1978 |
| hydrocortisone [0.25 to 0.50% (topical)] | Cortaid, Lanacort | anti-itch | Dec. 4, 1979 |
| hydrocortisone acetate [0.25 to 0.50% (topical)] | Bactine | anti-itch | Dec. 4, 1979 |
| acidulated phosphate fluoride rinse [0.02% fluoride in aqueous solution] | n/a | dental rinse | Mar. 28, 1980 |
| sodium fluoride rinse [0.05% aqueous solution (topical)] | Fluorigard | dental rinse | Mar. 28, 1980 |
| stannous fluoride gel [0.4% gel (topical)] | GelKam Gel | anti tooth decay gel | Mar. 28, 1980 |
| stannous fluoride rinse [0.1% aqueous solution (topical)] | n/a | dental rinse | Mar. 28, 1980 |
| ephedrine sulfate [0.1 to 1.25% (topical)] | Pazo Ointment | anorectal/ vasoconstrictor | May 27, 1980 |
| epinephrine hydrochloride [0.005 to 0.01% (topical)] | n/a | anorectal/ vasoconstrictor | May 27, 1980 |
| phenylephrine hydrochloride [0.25% (topical)] | n/a | anorectal/ vasoconstrictor | May 27, 1980 |
| chlorpheniramine maleate [12 mg/12 hours (oral timed-release)] | Triaminic 12 | antihistamine | July 23, 1981 |
| phenylpropanolamine hydrochloride [75 mg/12 hours (oral timed-release)] | n/a | nasal decongestant | July 23, 1981 |
| diphenhydramine hydrochloride [25 mg/4 hours (oral)] | Benylin | cough relief and prevention | Aug. 7, 1981 |
| haloprogin [1.0% (topical)] | n/a | antifungal | Mar. 23, 1982 |
| miconazole nitrate [2.0% (topical)] | Micatin | antifungal | Mar. 23, 1982 |
| diphenhydramine hydrochloride [50 mg single dose only (oral)] | Sominex 2 | sleep-aid | Apr. 23, 1982 |
| diphenhydramine monocitrate [76 mg single dose only (oral)] | Excedrin PM | sleep-aid | Apr. 23, 1982 |
| dyclonine hydrochloride [0.05 to 0.1% solution or suspension, 1 to 3 mg as lozenge] | Sucrets Maximum Relief | oral anesthetic | May 25, 1982 |
| dexbrompheniramine maleate [6 mg/12 hours (oral timed-release)] | Drixoral | antihistamine | Sep. 3, 1982 |
| pseudoephedrine sulfate [120 mg/12 hours (oral timed-release)] | Afrinol Repetabs | nasal decongestant | Sep. 3, 1982 |
| triprolidine hydrochloride [2.5 mg/4-6 hours] | Actifed Capsules | antihistamine | Nov. 26, 1982 |
| ibuprofen [200 mg/4-6 hours (oral)] | Advil, Nuprin | internal pain relief /fever reducer | May 18, 1984 |
| dexbrompheniramine maleate [2 mg/4-6 hours (oral)] | n/a | antihistamine | Jan. 15, 1985 |
| diphenhydramine hydrochloride [25-50 mg/4-6 hours (oral)] | Benadryl | antihistamine | Jan. 15, 1985 |
| pseudoephedrine hydrochloride [120 mg/12 hours (oral timed-release)] | Actifed | nasal decongestant | June 17, 1985 |
| triprolidine hydrochloride [5 mg/12 hours] | Actifed 12-hour Capsules | antihistamine | June 17, 1985 |
| oxymetazoline hydrochloride [0.025% solution/drops (topical)] | Ocuclear | ocular vasoconstrictor | May 30, 1986 |
| pyrantel pamoate [11 mg/kg of body weight maximum dose 1 g (oral)] | Pin-X | antiparasitic worms | Aug. 1, 1986 |
| povidone iodine sponge [10% (new dosage form)] | E-Z Scrub 241 | antimicrobial | Jan. 7, 1987 |
| diphenhydramine hydrochloride [25-50 mg/4-6 hours (oral)] | n/a | anti-vomiting and nausea | Apr. 30, 1987 |
| dexbrompheniramine maleate [3 mg/6-8 hours (oral)] | Drixoral Plus | antihistamine | May 22, 1987 |
| chlophedianol hydrochloride [25 mg/6-8 hours (oral)] | n/a | prevention or relief of cough | Aug. 12, 1987 |
| doxylamine succinate [7.5 mg - 12.5 mg./4-6 hours (oral)] | Nyquil | antihistamine | Aug. 24, 1987 |
| loperamide [4 mg, then 2 mg, 8 mg/day (oral)] | Imodium A-D | antidiarrheal | Mar. 3, 1988 |
| hydrogenated soybean oil and lecithin [12.4 g powder in 2-3 oz water; 20 minutes before gall bladder x-rays] | Liposperse | gallbladder emptying drug | Feb. 28, 1989 |
| clotrimazole [1% lotion and cream/2 times daily] | Lotrimin AF | antifungal | Oct. 23, 1989 |
| permethrin [1% cream rinse] | Nix | lice killer | May 5, 1990 |
| clotrimazole [1% cream & 100 mg inserts] | Gyne-Lotrimin | anticandidal | Nov. 30, 1990 |
| miconazole nitrate [2.0% cream and 100 mg inserts] | Monistat 7 | anticandidal | Mar. 13, 1991 |
| hydrocortisone+ [Above 0.50% to 1.0%] | n/a | anti-itch | Aug. 30, 1991 |
| hydrocortisone acetate+ [Above 0.50% to 1.0%] | n/a | anti-itch | Aug. 30, 1991 |
| clemastine fumarate [1.34 mg/12 hours] | Tavist-1 | antihistamine | Aug. 21, 1992 |
| clemastine fumarate (in combination with phenylpropanolamine HCl [1.34 mg/12 hours] | Tavist-D | antihistamine/ decongestant | Aug. 21, 1992 |
| dexchlorpheniramine maleate [2 mg/4-6 hours (oral)] | n/a | antihistamine | Dec. 9, 1992 |
| naproxen sodium [220 mg/4-6 hours (oral)] | Aleve | internal pain relief /fever reducer | Jan. 11, 1994 |
| pheniramine maleate with naphazoline HCl [0.3%; 0.025% in solution] | Naphcon A, Opcon A, Ocuhist | ophthalmic antihistamine/ decongestant | June 8, 1994 |
| antazoline phosphate with naphazoline HCl [0.5%; 0.05% in solution] | Vasacon A | ophthalmic antihistamine/ decongestant | July 11, 1994 |
| famotidine [10 mg, up to 20 mg/day] | Pepcid AC | acid reducer | Apr. 28, 1995 |
| ibuprofen suspension [100mg/5ml for pediatric use 7.5 mg/kg up to 4 times a day] | Children's Motrin | internal pain relief /fever reducer | June 16, 1995 |
| cimetidine [200 mg up to twice per day] | Tagamet HB | acid reducer | June 16, 1995 |
| ketoprofen [12.5 mg every 4 to 6 hours] | Orudis KT | internal pain relief | Oct. 6, 1995 |
| ranitidine [75 mg up to twice per day] | Zantac 75 | acid reducer | Dec. 19, 1995 |
| butoconazole nitrate [2.0% cream and applicators (3 days)] | Femstat 3 | anticandidal | Dec. 26, 1995 |
| minoxidil [2.0% topical solution] | Rogaine | hair grower | Feb. 9, 1996 |
| nicotine polacrilex [2 mg and 4 mg gum] | Nicorette | smoking cessation | Feb. 9, 1996 |
| nizatidine [75 mg up to twice daily] | AXID AR | acid reducer | May 9, 1996 |
| miconazole nitrate [2.0% cream and 200-mg inserts] | Monistat 3 | anticandidal | Apr. 16, 1996 |
| nicotine transdermal system [15 mg. patch] | Nicotrol | smoking cessation | July 3, 1996 |
| nicotine transdermal system [21, 14, & 7 mg patch] | Nicoderm CQ, Habitrol | smoking cessation | Aug. 2, 1996 |
| cromolyn sodium [4% nasal solution] | Nasalcrom | allergy prevention & treatment | Aug. 2, 1996 |
| tioconazole [6.5% vaginal ointment] | Vagistat-1, Monistat 1 | anticandidal | Feb. 11, 1997 |
| ketoconazole [1% shampoo] | Nizoral | dandruff shampoo | Oct. 10, 1997 |
| terbinafine hydrochloride [1.0% cream] | Lamisil AT | antifungal | Mar. 9, 1999 |
| butenafine hydrochloride [1.0% cream] | Lotrimin Ultra | athlete's foot, jock itch, ringworm | Dec. 7, 2001 |
| guaifenesin extended-release tablet [600 or 1200 mg once or twice a day] | Mucinex | expectorant | July 12, 2002 |
| loratadine [10 mg/day] | Claritin Tablets, Claritin RediTabs, Claritin Syrup | antihistamine | Nov. 27, 2002 |
| loratadine, pseudoephedrine sulfate [10 mg loratadine, 240 mg pseudoephedrine sulfate Daily] | Claritin -D 12 Hour Extended Release Tablets, Claritin-D 24 Hour Extended Release Tablets | antihistamine/ decongestant | Nov. 27, 2002 |
| omeprazole magnesium [20 mg/day] | Prilosec OTC | acid reducer to treat frequent heartburn | June 20, 2003 |
| levonorgestrel [Two 0.75-mg tablets, with the second one taken 12 hours after the first] | Plan B | contraceptive | Aug. 24, 2006 |
| polyethylene glycol 3350 [17 g (scoopful) of powder per day in 8 oz of water] | MiraLAX | laxative | Oct. 6, 2006 |
| ketotifen [0.025% ophthalmic solution] | Zaditor | antihistamine eye drops | Oct. 19, 2006 |
| orlistat [60 mg; 180 mg daily max] | alli | weight loss aid | Feb. 7, 2007 |
| cetirizine HCl & pseudoephedrine HCl [5 mg cetirizine and 120 mg pseudoephedrine] | Zyrtec-D | antihistamine/ decongestant | Nov. 9, 2007 |
| cetirizine HCl [1 mg/ml (children’s syrup), 5 mg and 10 mg (tablets and chewable tablets)] | Zyrtec | antihistamine, hives relief | Nov. 16, 2007 |
| lansoprazole [15 mg/day] | Prevacid 24 HR | acid reducer to treat frequent heartburn | May 18, 2009 |
| levonorgestrel [1.5 mg] | Plan B One Step | contraceptive | July 10, 2009 |
| omeprazole and sodium bicarbonate [20 mg omeprazole and 1100 mg sodium bicarbonate] | Zegerid OTC | acid reducer to treat frequent heartburn | Dec. 1, 2009 |
| ibuprofen and phenylephrine HCl [200 mg ibuprofen and 10 mg phenylephrine HCl] | Advil Congestion Relief | pain reducer/ decongestant | May 27, 2010 |
| fexofenadine hydrochloride [30 mg; 60 mg; 180 mg 30 mg/5 mL] | Allegra | antihistamine | Jan. 24, 2011 |
| fexofenadine hydrochloride and pseudoephedrine HCl [60 mg; 120 mg] | Allegra D 12-Hour | antihistamine/ decongestant | Jan. 24, 2011 |
| fexofenadine hydrochloride and pseudoephedrine HCl [180 mg; 240 mg] | Allegra D 24-Hour | antihistamine/ decongestant | Jan. 24, 2011 |
| oxybutynin [3.9 mg] | Oxytrol for Women | overactive bladder | Jan. 25, 2013 |
| triamcinolone acetonide [55 mcg/spray, aqueous suspension] | Nasacort Allergy 24HR | intranasal steroid for allergic stuffy nose | Oct. 11, 2013 |
| esomeprazole magnesium [20 mg/day] | Nexium 24HR | acid reducer to treat frequent heartburn | Mar. 28, 2014 |
| fluticasone propionate [50 mcg/spray] | Flonase Allergy Relief | intranasal steroid for upper respiratory allergies | July 23, 2014 |
| budesonide [32 mcg/spray] | Rhinocort Allergy Spray | intranasal steroid for allergic stuffy nose | Mar. 23, 2015 |
| adapalene (sNDA) [0.1% gel, once daily] | Differin Gel | acne | July 8, 2016 |
| fluticasone furoate (sNDA) [27.5 mcg/spray] | Flonase Sensimist Allergy Relief | intranasal steroid for upper respiratory allergies | Aug. 2, 2016 |
| levocetirizine dihydrochloride [5 mg] | Xyzal Allergy 24 Allergy | antihistamine | Jan. 31, 2017 |
| brimonidine tartrate [0.025% ophthalmic solution] | Lumify | relief of redness of the eye due to minor eye irritations | Dec. 22, 2017 |
| diclofenac sodium [1% topical gel, 4 times per day] | Voltaren Arthritis Pain | topical pain | Feb. 14, 2020 |
| olopatadine hydrochloride [0.1% ophthalmic spray, twice daily] | Pataday Twice Daily Relief | antihistamine and redness reliever | Feb. 14, 2020 |
| olopatadine hydrochloride [0.2% ophthalmic spray, once daily] | Pataday Once Daily Relief | antihistamine | Feb. 14, 2020 |
| olopatadine hydrochloride [0.7% ophthalmic solution, once daily] | Pataday Once Daily Relief Extra Strength | antihistamine | July 13, 2020 |
| ivermectin [0.5% lotion, single use tube] | Sklice | lice treatment | Oct. 27, 2020 |
| azelastine hydrochloride [0.15% nasal spray, 205.5 mcg/spray] | Astepro | antihistamine | June 17, 2021 |
| alcaftadine [0.25% ophthalmic solution, once daily] | Lastacaft | antihistamine | Dec. 10, 2021 |
| mometasone furoate [0.05 mcg/spray] | Nasonex 24HR Allergy | antihistamine | Mar. 17, 2022 |
| naloxone hydrochloride [4 mg nasal spray] | Narcan | treatment for opioid overdose | Mar. 29, 2023 |
| norgestrel [0.075 mg] | Opill | birth control | July 13, 2023 |
| naloxone hydrochloride [3 mg nasal spray] | RiVive | treatment for opioid overdose | July 28, 2023 |
Glossary
Anorectal/vasoconstrictor: A drug used to shrink blood vessels in the anus and rectum area. Used for conditions such as hemorrhoids.
Anticandidal: A drug that treats Candidal vaginitis, a vaginal infection.
Expectorant: A drug that loosens mucus so it can be coughed up.
Ocular Vasoconstrictor: A drug that restricts blood vessels in the eye to relieve redness due to minor irritation.
Sources
Consumer Healthcare Products Association, “FAQs about Rx-to-OTC Switch,” chpa.org (accessed Mar. 10, 2022)
Consumer Healthcare Products Association (CHPA), “Switch List,” chpa.org, Aug. 23, 2023
Drugs.com, “OcuClear Drops,” drugs.com (accessed Nov. 16, 2018)
FDA, “Prescription to Over-the-Counter (OTC) Switch List,” fda.gov, July 17, 2023
Oluwatosin Goje, “Candidal Vaginitis,” merckmanuals.com, May 2018
Healthline.com, “5 Natural Expectorants to Kill Your Cough,” healthline.com, July 11, 2017
WebMD, “Pazo Hemorrhoidal Ointment,” webmd.com (accessed Nov. 16, 2018)
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