Last updated on: 11/14/2018 10:48:02 PM PST

Drugs Switched from Prescription to Over-the-Counter Status

Between Sep. 9, 1976 and Jan. 3, 2018, 96 drug ingredients were switched from prescription (Rx) to over-the-counter (OTC) status by the FDA.

 Ingredient
[Adult Dosage]
Brand Name ExamplesDrug CategoryDate of Rx to OTC Switch
1brompheniramine maleate
[4 mg/4-6 hours (oral)]
DimetappantihistamineSep. 9, 1976
2chlorpheniramine maleate
[4 mg/4-6 hours (oral)]
Chlor-Trimeton, Coricidin HBP, Triaminic Cold & AllergyantihistamineSep. 9, 1976
3oxymetazoline hydrochloride
[0.05% aqueous solution (topical)]
Afrin, Neo-Synephrine-12 Hournasal decongestantSep 9, 1976
4pseudoephedrine hydrochloride
[60 mg/4 or 4-6 hours (oral) 240 mg max./24 hours]
Sudafednasal decongestantSep 9. 1976
5pseudoephedrine sulfate
[60 mg/4 or 4-6 hours (oral)]
Drixoralnasal decongestantSep 9. 1976
6xylometazoline hydrochloride
[0.01% aqueous solution (topical)]
Natru-Ventnasal decongestantSep. 9, 1976
7doxylamine succinate
[25 mg single dose only (oral)]
Unisomsleep-aidOct. 18, 1978
8hydrocortisone
[0.25 to 0.50% (topical)]
Cortaid, Lanacortanti-itchDec. 4, 1979
9hydrocortisone acetate
[0.25 to 0.50% (topical)]
Bactineanti-itchDec. 4, 1979
10acidulated phosphate fluoride rinse
[0.02% fluoride in aqueous solution]
n/adental rinseMar. 28, 1980
11sodium fluoride rinse
[0.05% aqueous solution (topical)]
Fluorigarddental rinseMar. 28, 1980
12stannous fluoride gel
[0.4% gel (topical)]
GelKam Gelanti tooth decay gelMar. 28, 1980
13stannous fluoride rinse
[0.1% aqueous solution (topical)]
n/adental rinseMar. 28, 1980
14ephedrine sulfate
[0.1 to 1.25% (topical)]
Pazo Ointmentanorectal/ vasoconstrictorMay 27, 1980
15epinephrine hydrochloride
[0.005 to 0.01% (topical)]
n/aanorectal/ vasoconstrictorMay 27, 1980
16phenylephrine hydrochloride
[0.25% (topical)]
n/aanorectal/ vasoconstrictorMay 27, 1980
17chlorpheniramine maleate
[12 mg/12 hours (oral timed-release)]
Triaminic 12antihistamineJuly 23, 1981
18phenylpropanolamine hydrochloride
[75 mg/12 hours (oral timed-release)]
n/anasal decongestantJuly 23, 1981
19diphenhydramine hydrochloride
[25 mg/4 hours (oral)]
Benylincough relief and preventionAug. 7, 1981
20haloprogin
[1.0% (topical)]
n/aantifungalMar. 23, 1982
21miconazole nitrate
[2.0% (topical)]
MicatinantifungalMar. 23, 1982
22diphenhydramine hydrochloride
[50 mg single dose only (oral)]
Sominex 2sleep-aidApr. 23, 1982
23diphenhydramine monocitrate
[76 mg single dose only (oral)]
Excedrin PMsleep-aidApr. 23, 1982
24dyclonine hydrochloride
[0.05 to 0.1% solution or suspension, 1 to 3 mg as lozenge]
Sucrets Maximum Relieforal anestheticMay 25, 1982
25dexbrompheniramine maleate
[6 mg/12 hours (oral timed-release)]
DrixoralantihistamineSep. 3, 1982
26pseudoephedrine sulfate
[120 mg/12 hours (oral timed-release)]
Afrinol Repetabsnasal decongestantSep. 3, 1982
27triprolidine hydrochloride
[2.5 mg/4-6 hours]
Actifed CapsulesantihistamineNov. 26, 1982
28ibuprofen
[200 mg/4-6 hours (oral)]
Advil, Nuprininternal pain relief /fever reducerMay 18, 1984
29dexbrompheniramine maleate
[2 mg/4-6 hours (oral)]
n/aantihistamineJan. 15, 1985
30diphenhydramine hydrochloride
[25-50 mg/4-6 hours (oral)]
BenadrylantihistamineJan. 15, 1985
31pseudoephedrine hydrochloride
[120 mg/12 hours (oral timed-release)]
Actifednasal decongestantJune 17, 1985
32triprolidine hydrochloride
[5 mg/12 hours]
Actifed 12-hour CapsulesantihistamineJune 17, 1985
33oxymetazoline hydrochloride
[0.025% solution/drops (topical)]
Ocuclearocular vasoconstrictorMay 30, 1986
34pyrantel pamoate
[11 mg/kg of body weight
maximum dose 1 g (oral)]
Pin-Xantiparasitic wormsAug. 1, 1986
35povidone iodine sponge
[10% (new dosage form)]
E-Z Scrub 241antimicrobialJan. 7, 1987
36diphenhydramine hydrochloride
[25-50 mg/4-6 hours (oral)]
n/aanti-vomiting and nauseaApr. 30, 1987
37dexbrompheniramine maleate
[3 mg/6-8 hours (oral)]
Drixoral PlusantihistamineMay 22, 1987
38chlophedianol hydrochloride
[25 mg/6-8 hours (oral)]
n/aprevention or relief of coughAug. 12, 1987
39doxylamine succinate
[7.5 mg - 12.5 mg./4-6 hours (oral)]
NyquilantihistamineAug. 24, 1987
40loperamide
[4 mg, then 2 mg, 8 mg/day (oral)]
Imodium A-DantidiarrhealMar. 3, 1988
41hydrogenated soybean oil and lecithin
[12.4 g powder in 2-3 oz water; 20 minutes before gall bladder x-rays]
Lipospersegallbladder emptying drugFeb. 28, 1989
42clotrimazole
[1% lotion and cream/2 times daily]
Lotrimin AFantifungalOct. 23, 1989
43permethrin
[1% cream rinse]
Nixlice killerMay 5, 1990
44clotrimazole
[1% cream & 100 mg inserts]
Gyne-LotriminanticandidalNov. 30, 1990
45miconazole nitrate
[2.0% cream and 100 mg inserts]
Monistat 7anticandidalMar. 13, 1991
46hydrocortisone+
[Above 0.50% to 1.0%]
n/aanti-itchAug. 30, 1991
47hydrocortisone acetate+
[Above 0.50% to 1.0%]
n/aanti-itchAug. 30, 1991
48clemastine fumarate
[1.34 mg/12 hours]
Tavist-1antihistamineAug. 21, 1992
49clemastine fumarate (in combination with phenylpropanolamine HCl
[1.34 mg/12 hours]
Tavist-Dantihistamine/ decongestantAug. 21, 1992
50dexchlorpheniramine maleate
[2 mg/4-6 hours (oral)]
n/aantihistamineDec. 9, 1992
51naproxen sodium
[220 mg/4-6 hours (oral)]
Aleveinternal pain relief /fever reducerJan. 11, 1994
52pheniramine maleate
with naphazoline HCl
[0.3%; 0.025% in solution]
Naphcon A, Opcon A, Ocuhistophthalmic antihistamine/
decongestant
June 8, 1994
53antazoline phosphate
with naphazoline HCl
[0.5%; 0.05% in solution]
Vasacon Aophthalmic antihistamine/
decongestant
July 11, 1994
54famotidine
[10 mg, up to 20 mg/day]
Pepcid ACacid reducerApr. 28, 1995
55ibuprofen suspension [100mg/5ml
for pediatric use
7.5 mg/kg up to 4 times a day]
Children's Motrininternal pain relief /fever reducerJune 16, 1995
56cimetidine
[200 mg up to twice per day]
Tagamet HBacid reducerJune 16, 1995
57ketoprofen
[12.5 mg every 4 to 6 hours]
Orudis KTinternal pain reliefOct. 6, 1995
58ranitidine
[75 mg up to twice per day]
Zantac 75acid reducerDec. 19, 1995
59butoconazole nitrate
[2.0% cream and applicators (3 days)]
Femstat 3anticandidalDec. 26, 1995
60minoxidil
[2.0% topical solution]
Rogainehair growerFeb. 9, 1996
61nicotine polacrilex
[2 mg and 4 mg gum]
Nicorettesmoking cessationFeb. 9, 1996
62nizatidine
[75 mg up to twice daily]
AXID ARacid reducerMay 9, 1996
63miconazole nitrate
[2.0% cream and 200-mg inserts]
Monistat 3anticandidalApr. 16, 1996
64nicotine transdermal system
[15 mg. patch]
Nicotrolsmoking cessationJuly 3, 1996
65nicotine transdermal system
[21, 14, & 7 mg patch]
Nicoderm CQ, Habitrolsmoking cessationAug. 2, 1996
66cromolyn sodium
[4% nasal solution]
Nasalcromallergy prevention & treatmentAug. 2, 1996
67tioconazole
[6.5% vaginal ointment]
Vagistat-1, Monistat 1anticandidalFeb. 11, 1997
68ketoconazole
[1% shampoo]
Nizoraldandruff shampooOct. 10, 1997
69terbinafine hydrochloride
[1.0% cream]
Lamisil ATantifungalMar. 9, 1999
70butenafine hydrochloride
[1.0% cream]
Lotrimin Ultraathlete's foot, jock itch, ringwormDec. 7, 2001
71guaifenesin extended-release tablet
[600 or 1200 mg once or twice a day]
MucinexexpectorantJuly 12, 2002
72loratadine
[10 mg/day]
Claritin Tablets, Claritin RediTabs, Claritin SyrupantihistamineNov. 27, 2002
73loratadine, pseudoephedrine sulfate
[10 mg loratadine, 240 mg pseudoephedrine sulfate
Daily]
Claritin -D 12 Hour Extended Release Tablets, Claritin-D 24 Hour Extended Release Tabletsantihistamine/
decongestant
Nov. 27, 2002
74omeprazole magnesium
[20 mg/day]
Prilosec OTCacid reducer to treat frequent heartburnJune 20, 2003
75levonorgestrel
[Two 0.75-mg tablets, with the second one taken 12 hours after the first]
Plan BcontraceptiveAug. 24, 2006
76polyethylene glycol 3350
[17 g (scoopful) of powder per day in 8 oz of water]
MiraLAXlaxativeOct. 6, 2006
77ketotifen
[0.025% ophthalmic solution]
Zaditorantihistamine eye dropsOct. 19, 2006
78orlistat
[60 mg; 180 mg daily max]
alliweight loss aidFeb. 7, 2007
79cetirizine HCl & pseudoephedrine HCl
[5 mg cetirizine and 120 mg pseudoephedrine]
Zyrtec-Dantihistamine/
decongestant
Nov. 9, 2007
80cetirizine HCl
[1 mg/ml (children’s syrup), 5 mg and 10 mg (tablets and chewable tablets)]
Zyrtecantihistamine, hives reliefNov. 16, 2007
81lansoprazole
[15 mg/day]
Prevacid 24 HRacid reducer to treat frequent heartburnMay 18, 2009
82levonorgestrel
[1.5 mg]
Plan B One StepcontraceptiveJuly 10, 2009
83omeprazole and sodium
bicarbonate
[20 mg omeprazole and 1100 mg sodium bicarbonate]
Zegerid OTCacid reducer to treat frequent heartburnDec. 1, 2009
84ibuprofen and phenylephrine HCl
[200 mg ibuprofen and 10 mg phenylephrine HCl]
Advil Congestion Reliefpain reducer/
decongestant
May 27, 2010
85fexofenadine hydrochloride
[30 mg; 60 mg; 180 mg
30 mg/5 mL]
AllegraantihistamineJan. 24, 2011
86fexofenadine hydrochloride and pseudoephedrine HCl
[60 mg; 120 mg]
Allegra D 12-Hourantihistamine/
decongestant
Jan. 24, 2011
87fexofenadine hydrochloride and pseudoephedrine HCl
[180 mg; 240 mg]
Allegra D 24-Hourantihistamine/
decongestant
Jan. 24, 2011
88oxybutynin
[3.9 mg]
Oxytrol for Womenoveractive bladderJan. 25, 2013
89triamcinolone acetonide
[55 mcg/spray, aqueous suspension]
Nasacort Allergy 24HRintranasal steroid for allergic stuffy noseOct. 11, 2013
90esomeprazole magnesium
[20 mg/day]
Nexium 24HRacid reducer to treat
frequent heartburn
Mar. 28, 2014
91fluticasone propionate
[50 mcg/spray]
Flonase Allergy Reliefintranasal steroid for upper respiratory allergiesJuly 23, 2014
92budesonide
[32 mcg/spray]
Rhinocort Allergy Sprayintranasal steroid for
allergic stuffy nose
Mar. 23, 2015
93adapalene (sNDA)
[0.1% gel, once daily]
Differin GelacneJuly 8, 2016
94fluticasone furoate (sNDA)
[27.5 mcg/spray]
Flonase Sensimist Allergy Reliefintranasal steroid for upper respiratory allergiesAug. 2, 2016
95levocetirizine dihydrochloride
[5 mg]
Xyzal Allergy 24 AllergyantihistamineJan. 31, 2017
96brimonidine tartrate
[0.025% ophthalmic solution]
Lumifyrelief of redness of the eye due to minor eye irritationsDec. 22, 2017

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 Oct. 25, 2018)

Drugs.com, “OcuClear Drops,” drugs.com (accessed Nov. 16, 2018)

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)