The United States Food and Drug Administration (FDA) proposed removing oral phenylephrine (PE) from over-the-counter single-agent and combination products because it is ineffective at FDA-approved doses to treat sinonasal congestion. Health care providers make thousands of recommendations per month for phenylephrine-containing over-the-counter products to treat adults and children with signs and symptoms of the common cold, specifically nasal congestion. Health care providers may feel compelled by parents to recommend over-the-counter medications to treat the common cold in children, despite resources suggesting those products may be mildly effective, ineffective, or possibly unsafe. The objective of this Pharmacotherapy Update is to suggest alternative treatments to PE in children with the common cold and nasal congestion.
ScolaroKL. . Colds and allergy. In: Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. (KrinskyDL, FerreriSP, HemstreetBA, et al. eds.) American Pharmacists Association: Washington D.C.; 2025.
3.
DykewiczMS, WallaceDV, AmrolDJ, et al.; Workgroup Contributors. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol, 2020; 146(4):721–767; doi: 10.1016/j.jaci.2020.07.007
4.
WallaceDV, DykewiczMS, BernsteinDI, et al.; Joint Council of Allergy, Asthma and Immunology. The diagnosis and management of rhinitis: An updated practice parameter. J Allergy Clin Immunol, 2008; 122(2 Suppl):S1–S84; doi: 10.1016/j.jaci.2008.06.003
5.
BiezenR, BrijnathB, GrandoD, et al.Management of respiratory tract infections in young children—A qualitative study of primary care providers’ perspectives. NPJ Prim Care Respir Med, 2017; 27(1):15; doi: 10.1038/s41533-017-0018-x
6.
TilleyDG, HouserSR, KochWJ. Adrenergic Agonists and Antagonists. McGraw Hill Medical: Philadelphia, PA; 2023.
HattonRC, HendelesL. What we have learned from trying to remove oral phenylephrine from the market. J Am Coll Clin Pharm, 2025; 8(3):214–223; doi: 10.1002/jac5.2080
DeckxL, De SutterAI, GuoL, et al.Nasal decongestants in monotherapy for the common cold. Cochrane Database Syst Rev, 2016; 10(10):CD009612; doi: 10.1002/14651858.CD009612.pub2
12.
HattonRC, HendelesL. Over-the-Counter oral phenylephrine: A placebo for nasal congestion. J Allergy Clin Immunol Pract, 2015; 3(5):709–710; doi: 10.1016/j.jaip.2015.06.014
13.
HattonRC, WintersteinAG, McKelveyRP, et al.Efficacy and safety of oral phenylephrine: Systematic review and meta-analysis. Ann Pharmacother, 2007; 41(3):381–390; doi: 10.1345/aph.1H679
14.
MeltzerEO, RatnerPH, McGrawT. Oral phenylephrine HCl for nasal congestion in seasonal allergic rhinitis: A randomized, open-label, placebo-controlled study. J Allergy Clin Immunol Pract, 2015; 3(5):702–708; doi: 10.1016/j.jaip.2015.05.007
15.
ChoSH, NandaA, KeswaniA, et al.Nasal Allergen Challenge (NAC): Practical aspects and applications from an EU/US perspective-a work group report of the AAAAI rhinitis, rhinosinusitis and ocular allergy committee. J Allergy Clin Immunol, 2023; 151(5):1215–1222.e4; doi: 10.1016/j.jaci.2023.02.014
AndersonTS, SudaKJ, GelladWF, et al.Trends in phenylephrine and pseudoephedrine sales in the US. JAMA, 2024; 331(9):796–798; doi: 10.1001/jama.2023.27932
18.
van DrielML, ScheireS, DeckxL, et al.What treatments are effective for common cold in adults and children? Bmj, 2018; 363:k3786; doi: 10.1136/bmj.k3786
De SutterAI, SaraswatA, van DrielML. Antihistamines for the common cold. Cochrane Database Syst Rev, 2015; 2015(11):CD009345; doi: 10.1002/14651858.CD009345.pub2
21.
DresslerWE, MyersT, RankellAS, et al.A system of rhinomanometry in the clinical evaluation of nasal decongestants. Ann Otol Rhinol Laryngol, 1977; 86(3 Pt 1):310–317; doi: 10.1177/000348947708600306
22.
Pediatric and Neonatal Lexi-Drugs. Wolters Kluwer Health: 2025. Available from: http://www.online.lexi.com
GelotteCK, AlbrechtHH, HynsonJ, et al.A multicenter, randomized, placebo-controlled study of pseudoephedrine for the temporary relief of nasal congestion in children with the common cold. J Clin Pharmacol, 2019; 59(12):1573–1583; doi: 10.1002/jcph.1472
25.
MinYG, YunYS, RheeCS, et al.Effects of phenylephrine on ciliary beat in human nasal respiratory epithelium: Quantitative measurement by video-computerized analysis. Laryngoscope, 1998; 108(3):418–421; doi: 10.1097/00005537-199803000-00019
26.
CruzM, RoteiaC, Marques FerreiraA, et al.Nasal irrigation with saline solution for pediatric acute upper respiratory infections: A systematic review. Cureus, 2024; 16(12):e75464; doi: 10.7759/cureus.75464
27.
SchenkelEJ, CieslaR, ShangaGM. Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: A randomized, placebo-controlled trial. Allergy Asthma Clin Immunol, 2018; 14:34; doi: 10.1186/s13223-018-0258-5
28.
ManoguerraAS, ErdmanAR, WaxPM, et al.; American Association of Poison Control Centers. Camphor Poisoning: An evidence-based practice guideline for out-of-hospital management. Clin Toxicol (Phila), 2006; 44(4):357–370; doi: 10.1080/15563650600671696
29.
PaulIM, BeilerJS, KingTS, et al.Vapor rub, petrolatum, and no treatment for children with nocturnal cough and cold symptoms. Pediatrics, 2010; 126(6):1092–1099; doi: 10.1542/peds.2010-1601
