Prescription to Nonprescription Switch List
This list only includes nonprescription drug products that have undergone a prescription-to-nonprescription (Rx-to-NonRx) switch in marketing status — just one of several ways to bring a nonprescription drug to market in the US. The list includes both full and partial switches from prescription to nonprescription marketing status.
For information on available nonprescription drug products brought to market via an NDA or ANDA drug application pathway, visit either Drugs@FDA or the Orange Book.
A large proportion of nonprescription drug products are brought to market through the OTC drug monograph pathway. To identify drug products reported by manufacturers to be in the OTC drug monograph marketing category, visit the FDA Online Label Repository, which can be searched by monograph ID.
Prescription to Nonprescription Switch List
| NDA Number | Drug Name | Purpose | Approval Date |
|---|---|---|---|
| NDA 208969/S-002 | Rextovy (naloxone hydrochloride) nasal spray, 4 mg/0.25 ml | Treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression | 6/16/2026 |
| NDA 220736 | Differin Epiduo Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5% gel) | Topical treatment of acne in adults and children ages 12 years and older | 5/22/2026 |
| NDA 17031/S-041 | Opill (norgestrel) tablet, 0.075 mg | Prevention of pregnancy | 7/13/2023 |
| NDA 208411/S-006 | Narcan (naloxone hydrochloride, 4 mg) nasal spray | Treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression | 3/29/2023 |
| NDA 215712 | Nasonex 24HR Allergy (mometasone furoate) nasal spray, 50 mcg/spray, metered | Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose | 3/17/2022 |
| NDA 22134/S-008 | Lastacaft (alcaftadine ophthalmic solution), 0.25% | Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander | 12/10/2021 |
| NDA 213872 | Astepro Allergy and Children’s Astepro Allergy (azelastine hydrochloride) nasal spray, 0.15% | Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose | 6/17/2021 |
| NDA 202736/S-006 | Sklice (ivermectin) lotion, 0.5% | Treats head lice infestation | 10/27/2020 |
| NDA 206276/S-005 | Pataday Once Daily Relief (olopatadine hydrochloride, 0.7%) | Temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, or dander | 7/13/2020 |
| NDA 22122/S-014 | Voltaren Arthritis Pain (diclofenac sodium) | Temporary relief of arthritis pain | 2/14/2020 |
| NDA 20688/S-032 | Pataday Twice Daily Relief (olopatadine hydrochloride, 0.1%) | Temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander | 2/14/2020 |
| NDA 21545/S-022 | Pataday Once Daily Relief (olopatadine hydrochloride, 0.2%) | Temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, or dander | 2/14/2020 |
| NDA 209089 | Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose; sneezing; itching of nose or throat; itchy, watery eyes (allergic rhinitis) | 1/31/2017 |
| NDA 209090 | Xyzal Allergy 24HR (levocetirizine dihydrochloride) solution | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose; sneezing; itching of nose or throat; itchy, watery eyes (allergic rhinitis) | 1/31/2017 |
| NDA 22051/S-013 | Flonase® Sensimist Allergy Relief (fluticasone furoate) | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose; itchy, watery eyes (allergic rhinitis) | 8/2/2016 |
| NDA 20380/S-010 | Differin Gel® (adapalene), 0.1% | Anti Acne | 7/8/2016 |
| NDA 20746/S-032 | Rhinocort Allergy Spray (budesonide) | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose (allergic rhinitis) | 3/23/2015 |
| NDA 2046551 | Nexium 24 HR (esomeprazole magnesium) | Frequent heartburn | 3/28/2014 |
| NDA 205434 | Flonase Allergy Relief (fluticasone proprionate) | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose; itchy, watery eyes (allergic rhinitis) | 7/23/2014 |
| NDA 202211 | Oxytrol for Women | Overactive bladder | 1/25/2013 |
| NDA 20468/S-035 | Nasacort Allergy 24HR (nasal spray) | Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose (allergic rhinitis) | 10/11/2013 |
| NDA 222831 | Zegerid OTC (omeprazole, 20mg and sodium bicarbonate, 1680 mg) powder for oral suspension | Frequent heartburn | 6/17/2013 |
| NDA 20786/S-027 | Allegra D 12 hr | Antihistamine | 1/24/2011 |
| NDA 21704/S-008 | Allegra 24 hr | Antihistamine | 1/24/2011 |
| NDA 20872/S-023 | Allegra | Antihistamine | 1/24/2011 |
| NDA 201373 | Allegra | Antihistamine | 1/24/2011 |
| NDA 21909/S-003 | Allegra | Antihistamine | 1/24/2011 |
| NDA 223271 | Prevacid 24 HR | Acid reducer/PPI | 5/18/2009 |
| NDA 222811 | Zegerid OTC | Acid reducer/PPI | 12/1/2009 |
| NDA 21150/S-007 | Zyrtec-D | Antihistamine and Nasal Decongestant | 11/9/2007 |
| NDA 22155 | Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (solution) | Antihistamine | 11/16/2007 |
| NDA 21621/S-005 | Children’s Zyrtec Allergy and Children’s Zyrtec Hives Relief (chewable tablets) | Antihistamine | 11/16/2007 |
| NDA 19835/S-022 | Zyrtec Allergy and Zyrtec Hives Relief (tablets) | Antihistamine | 11/16/2007 |
| NDA 21958 | Lamisil Derm Gel | Topical Antifungal | 7/24/2006 |
| NDA 21045/S-011 | Plan B | Emergency Contraceptive | 8/24/2006 |
| NDA 22015 | MiraLax | Laxative | 10/6/2006 |
| NDA 21066/S-011 | Zaditor | Antihistamine Eye Drop | 10/19/2006 |
| NDA 19658/S-020 | Claritin Hives Relief Tablets, Reditabs and Solution | Antihistamine | 11/19/2003 |
| NDA 20704/S-009 | Claritin Hives Relief Tablets, Reditabs and Solution | Antihistamine | 11/19/2003 |
| NDA 20641/S-011 | Claritin Hives Relief Tablets, Reditabs and Solution | Antihistamine | 11/19/2003 |
| NDA 20150/S-011 | Nicotrol TD | Smoking Cessation | 3/21/2002 |
| NDA 19658/S-018 | Claritin Tablets, Reditabs and Solution | Antihistamine | 11/27/2002 |
| NDA 20704/S-008 | Claritin Tablets, Reditabs and Solution | Antihistamine | 11/27/2002 |
| NDA 20641/S-009 | Claritin Tablets, Reditabs and Solution | Antihistamine | 11/27/2002 |
| NDA 19670/S-018 | Claritin-D | Antihistamine/Decongestant | 11/27/2002 |
| NDA 20470/S-016 | Claritin-D 24-hour | Antihistamine/ Decongestant | 11/27/2002 |
| NDA 21307 | Lotrimin Ultra | Topical Antifungal | 12/7/2001 |
1. These NDAs are not true switches since the conditions of use were not marketed as a prescription product under an approved NDA prior to being approved for marketing OTC.