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Last updated May 16, 2022

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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)

 

+ 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