Naphazoline

Mechanism-of-action class: Adrenergic alpha-Agonists.

• Naphazoline hydrochloride 0.05% nasal drops are indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis. Temporarily relieves a stuffy nose.ICD-10: J00, J32.9

Adults and children 12 years of age and over: 1 or 2 drops in each nostril not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.

Do not exceed recommended dosage. This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection. Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use this product in children under 12 years of age because it may cause sedation if swallowed. When using this product avoid contact with the eyes.

• Jun 8, 1994NDANDA020226Alcon
• Jun 8, 1994NDANDA020065Bausch And Lomb
• Jan 31, 1996NDANDA020485Kenvue Brands
• Sep 27, 2010ANDAANDA078208Altaire Pharms Inc

1. 1Eye Irritation50322%
2. 2Mydriasis47221%
3. 3Drug Ineffective41218%
4. 4Vision Blurred23710%
5. 5Eye Pain1998.8%
6. 6Ocular Hyperaemia1838.1%
7. 7Condition Aggravated1536.8%
8. 8Off Label Use1416.2%
9. 9Headache1325.8%
10. 10Pain1175.2%
11. 11Fatigue1094.8%
12. 12Instillation Site Pain1064.7%
13. 13Product Use In Unapproved Indication934.1%
14. 14Rash914.0%
15. 15Medication Error883.9%

Recent PubMed references pinned to Naphazoline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Spectroscopic and Chemometric Evaluation of the Stability of Timolol, Naphazoline, and Diflunisal in the Presence of Reactive Excipients Under Forced Degradation Conditions.
  Molecules (Basel, Switzerland) · 2025 · Gumieniczek A, Wesolowski M, Berecka-Rycerz A, et al.
  PMID 41011699DOI 10.3390/molecules30183807
• Naphazoline eye drops for the treatment of Horner syndrome following radical thyroid cancer surgery: A case report.
  The Journal of international medical research · 2025 · Li Z, Liu Y, Yin H, et al.
  PMID 40832951DOI 10.1177/03000605251359467
• Two Small Molecule Drugs with Topical Applications, Diflunisal and Naphazoline, and Their Potentially Toxic Photodegradants: Analysis by Chemical and Biological Methods.
  Molecules (Basel, Switzerland) · 2024 · Lejwoda K, Gumieniczek A, Filip A, et al.
  PMID 39274970DOI 10.3390/molecules29174122
• Naphazoline intoxication managed with minimally invasive cardiac output monitoring.
  The American journal of emergency medicine · 2024 · Oishi T, Kashiura M, Yasuda H, et al.
  PMID 38155033DOI 10.1016/j.ajem.2023.12.034
• Application of multivariate chemometrics tools for spectrophotometric determination of naphazoline HCl, pheniramine maleate and three official impurities in their eye drops.
  Scientific reports · 2023 · Kelani KM, Hegazy MA, Hassan AM, et al.
  PMID 37952008DOI 10.1038/s41598-023-46940-0
• Green Easily Implemented Spectrophotometric Methods for Concurrent Determination of Ephedrine Hydrochloride and Naphazoline Nitrate in Nasal Preparations Containing Methylparaben.
  Journal of AOAC International · 2023 · Abdelfatah RM, Magdy MA
  PMID 37140554DOI 10.1093/jaoacint/qsad050
• The early history of the knee-jerk reflex in neurology.
  Journal of the history of the neurosciences · 2022 · Lazar JW
  PMID 34995173DOI 10.1080/0964704X.2021.1980965
• Evaluation of Gingival Displacement with Aluminum Chloride and Naphazoline Hydrochloride: A Randomized Controlled Trial.
  The European journal of prosthodontics and restorative dentistry · 2021 · de Carvalho WF, Junior LCV, Junior HFB, et al.
  PMID 33026719DOI 10.1922/EJPRD_2066Junior10

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Naphazoline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• QOL Improvement After Cardioversion of Persistent AF (QOL-CAFRCT)
  Recruiting · Interventional · 100 enrolled · Ottawa Heart Institute Research Corporation
  NCT05136131updated 2025-12-15
• Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
  Completed · Phase 1 · Interventional · 34 enrolled · Sanofi
  NCT03324113updated 2025-08-05
• Safety and Tolerability of PRO-185
  Completed · Phase 1 · Interventional · 22 enrolled · Laboratorios Sophia S.A de C.V.
  NCT05470868updated 2025-07-17
• Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
  Completed · Phase 3 · Interventional · 144 enrolled · Bausch & Lomb Incorporated
  NCT00769886updated 2024-04-03
• Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease
  Not yet recruiting · Interventional · 96 enrolled · University Hospital, Montpellier
  NCT05998356updated 2023-09-21
• Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
  Completed · Phase 3 · Interventional · 141 enrolled · Bausch & Lomb Incorporated
  NCT00770133updated 2020-10-27
• Efficacy and Safety of Pediatric Drugs in Nasal Congestion
  Completed · Phase 3 · Interventional · 292 enrolled · EMS
  NCT02601235updated 2019-10-16
• Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
  Completed · Phase 3 · Interventional · 132 enrolled · EMS
  NCT01533220updated 2019-01-25
• Comparison of Tolerability Between Two Allergy Drops
  Unknown · Phase 4 · Interventional · 48 enrolled · Hom, Milton M., OD, FAAO
  NCT01390961updated 2011-07-11
• Comparison of CL Wear Between Two Allergy Drops
  Withdrawn · Phase 4 · Interventional · 25 enrolled · Hom, Milton M., OD, FAAO
  NCT00489398updated 2010-10-07

Frequently asked questions

How does Naphazoline work?

Mechanism-of-action class: Adrenergic alpha-Agonists.

What is Naphazoline used for?

According to FDA labeling, Naphazoline carries indications including: Naphazoline hydrochloride 0.05% nasal drops are indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis. Temporarily relieves a stuffy nose.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Naphazoline?

Naphazoline is classified as Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics, plain, Sympathomimetics used as decongestants, Adrenergic alpha-Agonists, Conjunctival Arterial Vasoconstriction, Decreased Nasal and Sinus Secretions.

What are the brand names for Naphazoline?

Naphazoline is marketed under brand names including AK-Con, Advanced Eye Relief Redness Instant Relief, All Clear, Naphcon A, Opcon-A, Privine.