Last updated August 23, 2023
| Ingredient | Adult Dosage | Product Category | Date of OTC Approval | Product Examples |
|---|---|---|---|---|
| brompheniramine maleate | 4 mg/4-6 hours (oral) | antihistamine | September 9, 1976 | Dimetapp |
| chlorpheniramine maleate | 4 mg/4-6 hours (oral) | antihistamine | September 9, 1976 | Chlor-Trimeton, Coridicin HBP, Triaminic Cold & Allergy |
| oxmetazoline hydrochloride | 0.05% aqueous solution (topical) | nasal decongestant | September 9, 1976 | Afrin, Neo-Synephrine-12 Hour |
| pseudoephedrine hydrochloride | 60 mg/4 or 4-6 hours (oral) 240 mg max./24 hours | nasal decongestant | September 9, 1976 | Sudafed |
| pseudoephedrine sulfate | 60 mg/4 or 4-6 hours (oral) | nasal decongestant | September 9, 1976 | Drixoral |
| xylometazoline hydrochloride | 0.01% aqueous solution (topical) | nasal decongestant | September 9, 1976 | Natru-Vent |
| doxylamine succinate (NDA) | 25 mg single dose only (oral) | sleep-aid | October 18, 1978 | Unisom |
| hydrocortisone | 0.25 to 0.50% (topical) | antipruritic (anti-itch) | December 4, 1979+ | Cortaid, Lanacort |
| hydrocortisone acetate | 0.25 to 0.50% (topical) | antipruritic (anti-itch) | December 4, 1979+ | Bactine |
| acidulated phosphate fluoride rinse | 0.02% fluoride in aqueous solution | dental rinse | March 28, 1980 | - |
| sodium fluoride rinse | 0.05% aqueous solution (topical) | dental rinse | March 28, 1980 | Fluorigard |
| stannous fluoride gel | 0.4% gel (topical) | anticaries gel | March 28, 1980 | GelKam Gel |
| stannous fluoride rinse | 0.1% aqueous solution (topical) | dental rinse | March 28, 1980 | - |
| ephedrine sulfate | 0.1 to 1.25% (topical) | anorectal/vasoconstrictor | May 27, 1980 | Pazo Ointment |
| epinephrine hydrochloride | 0.005 to 0.01% (topical) | anorectal/vasoconstrictor | May 27, 1980 | - |
| phenylephrine hydrochloride | 0.25% (topical) | anorectal/vasoconstrictor | May 27, 1980 | - |
| chlorpheniramine maleate (NDA) | 12 mg/12 hours (oral timed-release) | antihistamine | July 23, 1981 | Triaminic 12 |
| phenylpropanolamine hydrochloride (NDA) | 75 mg/12 hours (oral timed-release) | nasal decongestant | July 23, 1981 | - |
| diphenhydramine hydrochloride (NDA) | 25 mg/4 hours (oral) | antitussive | August 7, 1981 | Benylin |
| haloprogin | 1.0% (topical) | antifungal | March 23, 1982 | - |
| miconazole nitrate | 2.0% (topical) | antifungal | March 23, 1982 | Micatin |
| diphenhydramine hydrochloride | 50 mg single dose only (oral) | sleep-aid | April 23, 1982 | Sominex 2 |
| diphenhydramine monocitrate | 76 mg single dose only (oral) | sleep-aid | April 23, 1982 | Excedrin PM |
| dyclonine hydrochloride | 0.05 to 0.1% solution or suspension, 1 to 3 mg as lozenge | oral anesthetic | May 25, 1982 | Sucrets Maximum Strength |
| dexbrompheniramine maleate (NDA) | 6 mg/12 hours (oral timed-release) | antihistamine | September 3, 1982 | Drixoral |
| pseudoephedrine sulfate (NDA) | 120 mg/12 hours (oral timed-release) | nasal decongestant | September 3, 1982 | Afrinol Repetabs |
| triprolidine hydrochloride | 2.5 mg/4-6 hours | antihistamine | November 26, 1982 | Actifed Capsules |
| ibuprofen (NDA) | 200 mg/4-6 hours (oral) | internal analgesic/antipyretic | May 18, 1984 | Advil, Nuprin |
| dexbrompheniramine maleate | 2 mg/4-6 hours (oral) | antihistamine | January 15, 1985 | - |
| diphenhydramine hydrochloride | 25-50 mg/4-6 hours (oral) | antihistamine | January 15, 1985 | Benadryl |
| pseudoephedrine hydrochloride(NDA) | 120 mg/12 hours (oral timed-release) | nasal decongestant | June 17, 1985 | Actifed |
| triprolidine hydrochloride (NDA) | 5 mg/12 hours | antihistamine | June 17, 1985 | Actifed 12-hour Capsules |
| oxymetazoline hydrochloride (NDA) | 0.025% solution/drops (topical) | occular vasoconstrictor | May 30, 1986 | Ocuclear |
| pyrantel pamoate | 11 mg/kg of body weight maximum dose 1 g (oral) | anthelmintic | August 1, 1986 | Pin-X |
| povidone iodine sponge (NDA) | 10% (new dosage form) | antimicrobial | January 7, 1987 | E-Z Scrub 241 |
| diphenhydramine hydrochloride | 25-50 mg/4-6 hours (oral) | antiemetic | April 30, 1987 | - |
| dexbrompheniramine maleate (NDA) | 3 mg/6-8 hours (oral) | antihistamine | May 22, 1987 | Drixoral Plus |
| chlophedianol hydrochloride | 25 mg/6-8 hours (oral) | antitussive | August 12, 1987 | - |
| doxylamine succinate | 7.5 mg - 12.5 mg./4-6 hours (oral) | antihistamine | August 24, 1987 | Nyquil |
| loperamide (NDA) | 4 mg, then 2 mg, 8 mg/day (oral) | antidiarrheal | March 3, 1988 | Imodium A-D (Johnson & Johnson) |
| hydrogenated soybean oil and lecithin | 12.4 g powder in 2-3 oz water 20 minutes before gall bladder x-rays | cholecystokinetic | February 28, 1989 | Liposperse (Merck) |
| ibuprofen, pseudoephedrine HCl (NDA)* | 200 mg ibuprofen, 30 mg pseudoephedrine HCl | analgesic/decongestant | September 19, 1989 | Advil Cold and Sinus (Wyeth) |
| clotrimazole (NDA) | 1% lotion and cream/2 times daily | antifungal | October 23, 1989 | Lotrimin AF (Schering) |
| permethrin (NDA) | 1% cream rinse | pediculicide (head lice) | May 5, 1990 | Nix (Warner-Lambert) |
| clotrimazole (NDA) | 1% cream & 100 mg inserts | anticandidal | November 30, 1990 | Gyne-Lotrimin (Schering), Mycelex-7 (Miles) |
| miconazole nitrate | 2.0% cream and 100 mg inserts | anticandidal | March 13, 1991 | Monistat 7 (Ortho) |
| hydrocortisone+ | Above 0.50% to 1.0% | antipruritic (anti-itch) | August 30, 1991 | - |
| hydrocortisone acetate+ | Above 0.50% to 1.0% | antipruritic (anti-itch) | August 30, 1991 | - |
| clemastine fumarate (NDA) | 1.34 mg/12 hours | antihistamine | August 21, 1992 | Tavist-1 (Novartis) |
| clemastine fumarate (in combination with phenylpropanolamine HCl (NDA) | 1.34 mg/12 hours | antihistamine/decongestant | August 21, 1992 | Tavist-D (Novartis) |
| dexchlorpheniramine maleate | 2 mg/4-6 hours (oral) | antihistamine | December 9, 1992 | (last monograph switch) |
| naproxen sodium (NDA) | 220 mg/4-6 hours (oral) | internal analgesic/ antipyretic | January 11, 1994 | Aleve (Bayer) |
| pheniramine maleate with naphazoline HCl (NDA) | 0.3%; 0.025% in solution | ophthalmic antihistamine/ decongestant | June 8, 1994 | Naphcon A (Alcon), Opcon A (Bausch + Lomb) Ocuhist (Akorn) |
| antazoline phosphate with naphazoline HCl (NDA) | 0.5%; 0.05% in solution | ophthalmic antihistamine/ decongestant | July 11, 1994 | Vasocon A (Ciba) |
| famotidine (NDA) | 10 mg, up to 20 mg/day | acid reducer | April 28, 1995 | Pepcid AC (J&J·Merck) |
| ibuprofen suspension 100mg/5ml for pediatric use (NDA) | 7.5 mg/kg up to 4 times a day | internal analgesic/ antipyretic | June 16, 1995 | Children's Motrin (McNeil Consumer) |
| cimetidine (NDA) | 200 mg up to twice per day | acid reducer | June 19, 1995 | Tagamet HB (GlaxoSmithKline) |
| ketoprofen (NDA) | 12.5 mg every 4 to 6 hours | internal analgesic | October 6, 1995 | Orudis KT (Wyeth), Actron (Bayer) |
| ranitidine (NDA) | 75 mg up to twice per day | acid reducer | December 19, 1995 | Zantac 75 (McNeil) |
| butoconazole nitrate (NDA) | 2.0% cream and applicators (3 days) | anticandidal | December 26, 1995 | Femstat 3 (Procter & Gamble) |
| minoxidil (NDA) | 2.0% topical solution | hair grower | February 9, 1996 | Rogaine (McNeil) |
| nicotine polacrilex (NDA) | 2 mg and 4 mg gum | smoking cessation | February 9, 1996 | Nicorette (GlaxoSmithKline) |
| nizatidine (NDA) | 75 mg up to twice daily | acid reducer | May 9, 1996 | AXID AR (Wyeth) |
| miconazole nitrate (NDA) | 2.0% cream and 200-mg inserts | anticandidal | April 16, 1996 | Monistat 3 (Ortho) |
| nicotine transdermal system (NDA) | 15 mg. patch | smoking cessation | July 3, 1996 | Nicotrol (McNeil Consumer) |
| clotrimazole (NDA)* | 1% cream & 200 mg inserts | anticandidal | July 29, 1996 | Gyne-Lotrimin 3 (Schering-Plough) |
| nicotine transdermal system (NDA) | 21, 14, & 7 mg patch | smoking cessation | August 2, 1996 | Nicoderm CQ (GlaxoSmithKline Beecham) Habitrol (Novartis) (Nov. 12, 1999) |
| bentoquatam (NDA)* | 5% lotion | poison ivy protection | August 26, 1996 | Ivy Block (EnviroDerm) |
| cromolyn sodium (NDA) | 4% nasal solution | allergy prevention & treatment | January 6, 1997 | Nasalcrom (McNeil Consumer) |
| tioconazole (NDA) | 6.5% vaginal ointment | anticandidal | February 11, 1997 | Vagistat-1 (Bristol-Myers Squibb), Monistat 1 (McNeil) |
| loperamide/simethicone (NDA)* | 2 mg loperamide, 125 mg simethicone | antidiarrheal/antigas | June 26, 1997 | Imodium Advanced (McNeil Consumer) |
| triclosan (dentifrice) (NDA)* | 0.30% triclosan/0.243% fluoride | antigingivitis | July 11, 1997 | Total (Colgate-Palmolive) |
| ketoconazole (NDA) | 1% shampoo | dandruff shampoo | October 10, 1997 | Nizoral (Johnson & Johnson Consumer Products) |
| minoxidil (NDA)* | 5.0% topical solution | hair grower | November 17, 1997 | Rogaine Extra Strength for Men (Johnson & Johnson) |
| aspirin /caffeine /acetaminophen(NDA)** | 250 mg/65 mg/250 mg | migraine | January 14, 1998 | Excedrin Migraine (Novartis) |
| miconazole nitrate (NDA)* | 4.0% cream | anticandidal | March 30, 1998 | Monistat 3 (Advanced Care Products) |
| terbinafine hydrochloride (NDA) | 1.0% cream | antifungal | March 9, 1999 | Lamisil AT (Novartis) |
| cimetidine suspension (NDA)* | Suspension | acid reducer | July 9, 1999 | Tagamet HB 200 (GlaxoSmithKline) |
| naproxen Na, pseudoephedrine HCl (NDA)* | 220 mg naproxen Na, 120 mg pseudoephedrine HCl | analgesic/decongestant | November 29, 1999 | Aleve Cold & Sinus (Bayer Consumer Care) |
| ibuprofen (NDA)** | 200 mg | migraine | February 25, 2000 | Motrin Migraine Pain (McNeil Consumer Healthcare) |
| ibuprofen (NDA)** | 200 mg | migraine | March 16, 2000 | Advil Migraine Liqui-Gels (Wyeth) |
| docosanol (NDA)* | 10% cream | cold sore/fever blister | July 25, 2000 | Abreva Cream (Avanir Pharmaceuticals) |
| famotidine, calcium carbonate, magnesium hydroxide (NDA)* | 10 mg famotidine, 800 mg calcium carbonate, 165 mg magnesium hydroxide | heartburn, acid indigestion | October 17, 2000 | Pepcid Complete (J&J/Merck) |
| butenafine hydrochloride (NDA) | 1.0% cream | athlete's foot, jock itch, ringworm | December 7, 2001 | Lotrimin Ultra (Schering-Plough) |
| ibuprofen, pseudoephedrine HCl, suspension for pediatric use (NDA)* | 100 mg ibuprofen, 15 mg pseudo-ephedrine HCl/5 ml; 5 or 10 ml up to 4 times a day | analgesic/decongestant | April 18, 2002 | Children’s Advil Cold (Wyeth) |
| guaifenesin extended-release tablet (NDA) | 600 or 1200 mg once or twice a day | expectorant | July 12, 2002 | Mucinex (Adams Respiratory Therapeutics) |
| nicotine polacrilex troche/lozenge (NDA)* | 2 mg and 4 mg | smoking cessation | October 31, 2002 | Commit (GlaxoSmithKline) |
| loratadine (NDA) | 10 mg/day | antihistamine | November 27, 2002 | Claritin Tablets, Claritin RediTabs, Claritin Syrup (Schering-Plough) |
| loratadine, pseudoephededrine sulfate (NDA) | 10 mg loratadine, 240 mg pseudo- ephedrine sulfate Daily | antihistamine/ decongestant | November 27, 2002 | Claritin-D 12 Hour Extended Release Tablets, Claritin-D 24 Hour Extended Release Tablets (Schering-Plough) |
| omeprazole magnesium (NDA) | 20 mg/day | acid reducer to treat frequent heartburn | June 20, 2003 | Prilosec OTC (Procter & Gamble) |
| loratadine (NDA)** | 10 mg/day | hives relief | November 15, 2003 | Claritin hives relief (Schering-Plough) |
| diphenhydramine citrate & ibuprofen (NDA)*; diphenhydramine HCl & ibuprofen potassium (NDA)* | 400 mg ibuprofen and 78 mg diphenhydramine citrate or 50 mg diphenhydramine HCl at bedtime | analgesic sleep-aid | December 21, 2005 | Advil PM (Wyeth) |
| ecamsule (combined with avobenzone and octocrylene (NDA)* | 2% ecamsule; 2% avobenzone; 10% octocrylene | sunscreen | July 21, 2006 | Anthelios SX (L’Oreal) |
| levonorgestrel (NDA) | Two 0.75-mg tablets, with the second one taken 12 hours after the first | contraceptive | August 24, 2006 | Plan B (Duramed) |
| polyethylene glycol 3350 (NDA) | 17 g (scoopful) of powder per day in 8 oz of water | laxative | October 6, 2006 | MiraLAX (Schering-Plough) |
| ketotifen (NDA) | 0.025% ophthalmic solution | antihistamine eye drops | October 19, 2006 | Zaditor (Novartis) |
| orlistat (NDA) | 60 mg; 180 mg daily max. | weight loss aid | February 7, 2007 | alli (GlaxoSmithKline) |
| cetirizine HCl & pseudoephedrine HCl (NDA) | 5 mg cetirizine and 120 mg pseudoephedrine | antihistamine/ decongestant | November 9, 2007 | Zyrtec-D (McNeil) |
| cetirizine HCl (NDA) | 1 mg/ml (children’s syrup), 5 mg and 10 mg (tablets and chewable tablets) | antihistamine, hives relief | November 16, 2007 | Zyrtec (McNeil) |
| lansoprazole (NDA) | 15 mg/day | acid reducer to treat frequent heartburn | May 18, 2009 | Prevacid 24 HR (Novartis) |
| levonorgestrel (NDA) | 1.5 mg | contraceptive | July 10, 2009 | Plan B One Step (Duramed) |
| omeprazole and sodium bicarbonate (NDA) | 20 mg omeprazole and 1100 mg sodium bicarbonate | acid reducer to treat frequent heartburn | December 1, 2009 | Zegerid OTC (Schering-Plough) |
| ibuprofen and phenylephrine HCl (NDA) | 200 mg ibuprofen and 10 mg phenylephrine HCl | analgesic/decongestant | May 27, 2010 | Advil Congestion Relief (Pfizer) |
| fexofenadine hydrochloride (NDA) | 30 mg; 60 mg; 180 mg 30 mg/5 mL | antihistamine | January 24, 2011 | Allegra (Chattem) |
| fexofenadine hydrochloride and pseudoephedrine HCl (NDA) | 60 mg; 120 mg | antihistamine/ decongestant | January 24, 2011 | Allegra D 12-Hour (Chattem) |
| fexofenadine hydrochloride and pseudoephedrine HCl (NDA) | 180 mg; 240 mg | antihistamine/ decongestant | January 24, 2011 | Allegra D 24-Hour (Chattem) |
| oxybutynin (NDA) | 3.9 mg | overactive bladder | January 25, 2013 | Oxytrol for Women (Merck) |
| triamcinolone acetonide (NDA) | 55 mcg/spray, aqueous suspension | intranasal steroid for allergic rhinitis | October 11, 2013 | Nasacort Allergy 24HR (Chattem) |
| esomeprazole magnesium (NDA) | 20 mg/day | acid reducer to treat frequent heartburn | March 28, 2014 | Nexium 24HR (Pfizer) |
| fluticasone propionate (NDA) | 50 mcg/spray | intranasal steroid for upper respiratory allergies | July 23, 2014 | Flonase Allergy Relief (GlaxoSmithKline) |
| budesonide (NDA) | 32 mcg/spray | intranasal steroid for allergic rhinitis | March 23, 2015 | Rhinocort Allergy Spray (McNeil) |
| adapalene (sNDA) | 0.1% gel, once daily | acne | July 8, 2016 | Differin Gel (Galderma) |
| fluticasone furoate (sNDA) | 27.5 mcg/spray | intranasal steroid for upper respiratory allergies | August 2, 2016 | Flonase Sensimist Allergy Relief (GlaxoSmithKline) |
| levocetirizine dihydrochloride (NDA) | 5 mg | antihistamine | January 31, 2017 | Xyzal Allergy 24HR (Chattem) |
| brimonidine tartrate (NDA) | 0.025% ophthalmic solution | relief of redness of the eye due to minor eye irritations | December 22, 2017 | Lumify (Bausch + Lomb) |
| diclofenac sodium (sNDA) | 1% topical gel, 4 times per day | topical pain | February 14, 2020 | Voltaren Arthritis Pain (GSK) |
| olopatadine hydrochloride (sNDA) | 0.1% ophthalmic spray, twice daily | antihistamine and redness reliever | February 14, 2020 | Pataday Twice Daily Relief (Alcon) |
| olopatadine hydrochloride (sNDA) | 0.2% ophthalmic spray, once daily | antihistamine | February 14, 2020 | Pataday Once Daily Relief (Alcon) |
| acetaminophen and ibuprofen (NDA)* | 500 mg acetaminophen and 250 mg ibuprofen, every 8 hrs. | oral analgesic | February 28, 2020 | Advil Dual Action with Acetaminophen (GSK) |
| olopatadine hydrochloride (sNDA) | 0.7% ophthalmic solution, once daily | antihistamine | July 13, 2020 | Pataday Once Daily Relief Extra Strength (Alcon) |
| ivermectin (sNDA) | 0.5% lotion, single use tube | lice treatment | October 27, 2020 | Sklice (Arbor) |
| azelastine hydrochloride (NDA) | 0.15% nasal spray, 205.5 mcg/spray | antihistamine | June 17, 2021 | Astepro (Bayer) |
| alcaftadine (sNDA) | 0.25% ophthalmic solution, once daily | antihistamine | December 10, 2021 | Lastacaft (Allergan) |
| mometasone furoate (NDA) | 0.05 mcg/spray | antihistamine | March 17, 2022 | Nasonex 24HR Allergy (Perrigo) |
| naloxone hydrochloride (NDA) | 4 mg nasal spray | treatment of known or suspected opioid overdose | March 29, 2023 | Narcan (Emergent BioSolutions) |
| norgestrel (NDA) | 0.075 mg | prevention of pregnancy | July 13, 2023 | Opill (Perrigo) |
| naloxone hydrochloride (NDA) | 3 mg nasal spray | treatment of known or suspected opioid overdose | July 28, 2023 | RiVive (Harm Reduction Therapeutics) |
+ FDA approval for OTC marketing is on an interim basis pending adoption of a Final Monograph.
* New OTC NDA - Not previously Rx
**New OTC indication, product previously OTC