Drugplain

NAFASOLINA 50 mg/100mL

Naphazoline hydrochloride · SOLUTION/ DROPS · Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals

No Recall History
Plain English

NAFASOLINA is a solution/ drops containing naphazoline hydrochloride at 50 mg/100mL, taken nasal. Manufactured by Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals.

Key Facts

Brand Name
NAFASOLINA
Generic Name
Naphazoline hydrochloride
NDC Code (Product)
12539-146
Manufacturer
Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals
Strength
50 mg/100mL
Dosage Form
SOLUTION/ DROPS
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
03/20/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use96 reports
fatigue88 reports
drug ineffective84 reports
headache82 reports
inappropriate schedule of product administration80 reports
pain80 reports
pyrexia79 reports
rash79 reports
pain in extremity78 reports
weight decreased78 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. Helps clear nasal passages.

Dosage & Administration

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.

Warnings

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.

Frequently Asked Questions

What is NAFASOLINA used for?

NAFASOLINA contains Naphazoline hydrochloride. It is a solution/ drops taken nasal. Consult your doctor for specific uses.

Is NAFASOLINA a controlled substance?

NAFASOLINA is not classified as a controlled substance by the DEA.

What is the generic name for NAFASOLINA?

The generic name for NAFASOLINA is Naphazoline hydrochloride. There are 11 other brand versions of Naphazoline hydrochloride.

What is the NDC code for NAFASOLINA 50 mg/100mL?

The NDC (National Drug Code) for NAFASOLINA 50 mg/100mL is 12539-146, listed by Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals.