Learning Objectives
After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to:
- RECALL the history of phenylephrine’s approval and the FDA’s over-the-counter (OTC) approval process
- DESCRIBE the rise and fall of phenylephrine’s popularity
- DIFFERENTIATE oral phenylephrine from other routes of administration and their importance in practice
- DISTINGUISH alternative OTC congestion products to patients
Release Date
Release Date: March 20, 2026
Expiration Date: March 20, 2029
Course Fee
FREE
There is no funding for this CE.
ACPE UANs
Pharmacist: 0009-0000-26-019-H99-P
Pharmacy Technician: 0009-0000-26-019-H99-T
Session Codes
Pharmacist: 26POD19-YQX98
Pharmacy Technician: 26POD19-XYQ89
Accreditation Hours
0.5 hours of CE
Accreditation Statements
| The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Statements of credit for the online activity ACPE UAN 0009-0000-26-019-H99-P/T will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program. |  |
Disclosure of Discussions of Off-label and Investigational Drug Use
The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.
Faculty
Dylan Decandia PharmD
Freelance Medical Writer, Franklyn’s Pharmacy
Ho-Ho-Kus, NJ
Faculty Disclosure
In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.
Dylan Decandia PharmD has no relationships with ineligible companies.
Dylan Decandia, PharmD discusses topics in the pharmacy world with a new guest each episode. Catch the next episode on Spotify or Apple Podcasts.
DELVING BEYOND THE SHELVING PODCAST EPISODE 1
Listen on an App
Pharmacist Post Test (for viewing only)
POST TEST QUESTIONS
Pharm Fresh podcast Episode 1: Decongesting Phenylephrine Rumors
26-019 P
1. What is the formal name of the FDA’s “recipe book” for approved over-the-counter products?
a. OTC Monograph
b. FDA Approved OTCs
c. Monograph of Federal Approvals
*
2. When was Hatton and Hendeles’ first Citizens Petition for phenylephrine?
a. 2007
b. 2009
c. 2015
*
3. What was Hatton and Hendeles goal in the first Citizens Petition?
a. The FDA should remove oral phenylephrine from the market due to safety issues
b. The FDA should increase the recommended daily dose of oral phenylephrine
c. The FDA should move oral phenylephrine behind the counter with pseudoephedrine
*
4. Which law enacted in the 2000s was believed to cause increases in phenylephrine sales?
a. Family Smoking Prevention and Tobacco Control Act of 2009
b. Food and Drug Administration Amendments Act of 2007
c. Combat Methamphetamine Act of 2005
*
5. All phenylephrine routes of administration are effective in current therapies EXCEPT:
a. Ophthalmic
b. Intranasal
c. Oral
*
6. Which disease state indicates an intranasal phenylephrine product over an oral decongestant such as pseudoephedrine?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa
*
7. Which condition limits some congestion self-treatments to 3 days or less?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa
*
8. A mother presents to the pharmacy with her 9-year-old child. She states the child is congested, despite using Flonase for the last 2 months for allergies. As the pharmacist, what do you recommend to this patient?
a. Flonase Sensimist. She has exhausted the regular Flonase product and continued use might irritate the child’s nasal passages
b. Neti Pot. The patient has exhausted all Flonase products and non-pharmacological treatment may benefit this patient.
c. Recommend the patient to see their pediatrician. Over-the-counter treatment is no longer indicated in this patient.
Pharmacy Technician Post Test (for viewing only)
POST TEST QUESTIONS
Pharm Fresh podcast Episode 1: Decongesting Phenylephrine Rumors
26-019 T
1. What is the formal name of the FDA’s “recipe book” for approved over-the-counter products?
a. OTC Monograph
b. FDA Approved OTCs
c. Monograph of Federal Approvals
*
2. When was Hatton and Hendeles’ first Citizens Petition for phenylephrine?
a. 2007
b. 2009
c. 2015
*
3. What was Hatton and Hendeles goal in the first Citizens Petition?
a. The FDA should remove oral phenylephrine from the market due to safety issues
b. The FDA should increase the recommended daily dose of oral phenylephrine
c. The FDA should move oral phenylephrine behind the counter with pseudoephedrine
*
4. Which law enacted in the 2000s was believed to cause increases in phenylephrine sales?
a. Family Smoking Prevention and Tobacco Control Act of 2009
b. Food and Drug Administration Amendments Act of 2007
c. Combat Methamphetamine Act of 2005
*
5. All phenylephrine routes of administration are effective in current therapies EXCEPT:
a. Ophthalmic
b. Intranasal
c. Oral
*
6. Which disease state indicates an intranasal phenylephrine product over an oral decongestant such as pseudoephedrine?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa
*
7. Which condition limits some congestion self-treatments to 3 days or less?
a. Uncontrolled Hypertension
b. Nasal Polyps
c. Rhinitis Medicamentosa
*
8. A mother presents to the pharmacy with her 9-year-old child. She states the child is congested, despite using Flonase for the last 2 months for allergies. As the pharmacist, what do you recommend to this patient?
a. Flonase Sensimist. She has exhausted the regular Flonase product and continued use might irritate the child’s nasal passages
b. Neti Pot. The patient has exhausted all Flonase products and non-pharmacological treatment may benefit this patient.
c. Recommend the patient to see their pediatrician. Over-the-counter treatment is no longer indicated in this patient.
References
Full List of References
P5#. FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. U.S. Food and Drug Administration. November 07, 2024. Accessed January 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after
P8#. Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. Federal Register. November 11, 2024. Accessed January 15, 2025. https://www.federalregister.gov/d/2024-25910
P35#. OTC Drug Review Process | OTC Drug Monographs. U.S. Food and Drug Administration. October 10, 2023. Accessed January 29, 2025. https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs
P36#. FAQs About the OTC Review. Consumer Healthcare Products Association. Accessed February 10, 2025. https://www.chpa.org/about-consumer-healthcare/faqs/faqs-about-otc-review#:~:text=Each%20panel%20was%20charged%20with,of%20Federal%20Regulations%20(CFR)
P9#. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products. Federal Register. August 1, 2006. Accessed January 15, 2025. https://www.federalregister.gov/d/E6-12265
P4#. Code of Federal Regulations Title 21. National Archives. Last amended June 3, 2025. Accessed May 5, 2025. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-10/subpart-B/section-10.30
P7#. Hendeles L, Hatton R. Supplement to Oral Phenylephrine Citizen's Petition (FDA 2015-P-4131). May 2022. Accessed January 15, 2025. https://downloads.regulations.gov/FDA-2015-P-4131-0007/attachment_1.pdf
P3#. Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. U.S. Food and Drug Administration. July 14, 2025. Accessed January 12, 2025. https://www.fda.gov/drugs/information-drug-class/legal-requirements-sale-and-purchase-drug-products-containing-pseudoephedrine-ephedrine-and
P20#. Oral Phenylephrine as a Nasal Decongestant in the Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic (CCABA) OTC Monograph. 2023 Nonprescription Drugs Advisory Committee Meeting. U.S. Food and Drug Administration. September 11-12, 2024. Accessed January 18, 2025. https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-september-11-12-2023-meeting-nonprescription-drugs-advisory-committee-meeting-announcement#event-materials.
P19#. Hendeles L, Hatton R. Citizen’s petition 2015-P-4131-0001 requesting a final rule removing oral phenylephrine from the final monograph for OTC nasal decongestant products. November 4, 2015. https://downloads.regulations.gov/FDA-2015-P-4131-0001/attachment_1.pdf. Accessed May 6, 2025.
P17#. FDA Response to 2015 Citizens Petition. U.S. Food and Drug Administration. November 8, 2024. Accessed January 22, 2025.
P33#. Interim Response FDA-2015-P-4131. U.S. Food and Drug Administration. May 6, 2016. Accessed January 20, 2025. https://downloads.regulations.gov/FDA-2015-P-4131-0004/attachment_1.pdf
P1#. Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors. It’s Not Alone. October 05, 2023. Accessed January 10, 2025. https://medicine.yale.edu/news-article/phenylephrine-a-common-decongestant-is-ineffective-say-fda-advisors-its-not-alone/
P6#. Food and Drug Administration Center for Drug Evaluation and Research Final Summary Minutes of the Nonprescription Drugs Advisory Committee Meeting. October 2, 2023. Accessed January 14, 2025. https://www.fda.gov/media/172701/download
P32#. Anderson T, Suda K, Gellad W. Trends in Phenylephrine and Pseudoephedrine Sales in the US. March 5, 2024. DOI: 10.1001/jama.2023.27932.
P10#. CVS Health to no longer sell decongestants with phenylephrine as the only active ingredient. NBC News. October 19, 2023. Accessed January 15, 2025.
https://www.nbcnews.com/business/consumer/cvs-health-pull-decongestants-phenylephrine-shelves-rcna121310
P37#. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. U.S. Food and Drug Administration. April 1, 2020. Accessed February 8, 2025. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
P11#. Phenylephrine Nasal Spray. MedlinePlus. November 15, 2016. Accessed January 16, 2025. https://medlineplus.gov/druginfo/meds/a616049.html#:~:text=Phenylephrine%20comes%20as%20a%200.125,to%2012%20years%20of%20age.
P16#. Phenylephrine (Topical). Memorial Sloan Kettering Cancer Center. December 12, 2022. Access January 17, 2025. https://www.mskcc.org/cancer-care/patient-education/medications/adult/phenylephrine-topical
P12#. Phenylephrine (ophthalmic route). Mayo Clinic. Accessed January 16, 2025.
https://www.mayoclinic.org/drugs-supplements/phenylephrine-ophthalmic-route/description/drg-20067902
P13#. Phenylephrine (intravenous route). Mayo Clinic. Accessed January 16, 2025.
https://www.mayoclinic.org/drugs-supplements/phenylephrine-intravenous-route/description/drg-20110237
P14#. Morelli A, Ertmer C, Rehberg S, Lange M. Phenylephrine versus norepinephrine for initial hemodynamic support of patients with septic shock: a randomized, controlled trial. November 18, 2008. Accessed January 16. 2025. https://ccforum.biomedcentral.com/articles/10.1186/cc7121.
P15#. Cooper B. Review and update on inotropes and vasopressors. January 2008. Accessed January 17, 2025. DOI: 10.1097/01.AACN.0000310743.32298.1d
P24#. Johnson D, Hricik J. The pharmacology of Alpha-Adrenergic Decongestants. Pharmacotherapy. November-December 1993. Accessed January 20, 2025. https://pubmed.ncbi.nlm.nih.gov/7507588/
P25#. Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. American Heart Association. November 13, 2017. Accessed January 20, 2025. https://www.ahajournals.org/doi/10.1161/hyp.0000000000000065
P26#. Label: SUDAFED SINUS CONGESTION 24 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release. DailyMed. Last updated March 20, 2023. Accessed January 20, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d389347d-eaa3-4571-9b84-21e662db622d
P27#. Is Rinsing Your Sinuses With Neti Pots Safe? U.S. Food and Drug Administration. Last updated April 28, 2025. Accessed March 5, 2025.
https://www.fda.gov/consumers/consumer-updates/rinsing-your-sinuses-neti-pots-safe#:~:text=Some%20children%20are%20diagnosed%20with,might%20not%20tolerate%20the%20procedure
P28#. Rhinocort (budesonide) Nasal Spray Label. U.S. Food and Drug Administration. December 28, 2010. Accessed March 5, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf
P23#. Pseudoephedrine Capsules and Tablets. Cleveland Clinic. Last reviewed February 2024. Accessed January 20, 2025.
https://my.clevelandclinic.org/health/drugs/20768-pseudoephedrine-capsules-and-tablets
P29#. Label: NASACORT ALLERGY 24HR- triamcinolone acetonide spray, metered. DailyMed. Last updated July 1, 2024. Accessed March 5, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bff57a5-cce0-401c-a0fe-23c65c1b7ddc
P30#. FLONASE (fluticasone propionate) nasal spray label. U.S. Food and Drug Administration. December 28, 2010. Accessed March 5, 2025.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020121s045lbl.pdf
P31#. Label: FLONASE SENSIMIST ALLERGY RELIEF- fluticasone furoate spray, metered. Updated December 19, 2024. Accessed March 5, 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=107100af-7ca2-44e8-b067-c0ab0a19a6dc
P21#. Hermelingmeier K, Weber R, Hellmich M. Nasal irrigation as an adjunctive treatment in allergic rhinitis: A systematic review and meta-analysis. September-October 2012. Accessed May 5, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC3904042/
P22#. Reinikainen L, Jaakkola J. Significance of humidity and temperature on skin and upper airway symptoms. December 13, 2003. DOI: 10.1111/j.1600-0668.2003.00155.x.
P34#. Hatton R, Hendeles L. What we have learned from trying to remove oral phenylephrine from the market. January 29, 2025. Accessed March 5, 2025. https://doi.org/10.1002/jac5.2080
P35# Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Overthe-Counter Human Use. November 7, 2024. Accessed August 3, 2025. https://www.regulations.gov/document/FDA-2024-N-4734-0001.