OTC - ACTIVE INGREDIENT SECTION
Naphazoline hydrochloride 0.05% v/v. Purpose: Nasal decongestant
NAFASOLINA
- Manufacturer
- Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | DEXTRUM LABORATORIES INC.
- Effective date
- 2025-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:26:06
Label at a glance#
ProductNAFASOLINA
Active ingredientNAPHAZOLINE HYDROCHLORIDE
Label structure10 sections
Label contents#
Full prescribing information#
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Stop using this product after 3 days.
If symptoms persist, stop, and consult a doctor.
INACTIVE INGREDIENT SECTION
Benzalkonium chloride, purified water, sodium bisulfite, sodium chloride, and sodium citrate.
OTC - PURPOSE SECTION
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.
OTC - WHEN USING SECTION
Use for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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.
OTC - DO NOT USE SECTION
If you are pregnant or breast-feeding consult a health care professional before using this product.
Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2
weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.
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.
Do not use this product in a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.
This product is for nasal use only.
When using this product avoid contact with the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
INDICATIONS & USAGE SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
0.5 FL. OZ NDC: 12539-146-02
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| e18001c8-33ae-5f66-9cdc-a39724bd4573 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12539-146-01 | NAFASOLINA | 14.7868 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 14.7868 | 2 | |
| 12539-146-02 | NAFASOLINA | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 2 |
Products#
Every source-derived product name is available through these pages.
- NAFASOLINA
- Naphazoline hydrochloride
- WATER
- NAPHAZOLINE
- SODIUM BISULFITE
- BENZALKONIUM CHLORIDE
- SODIUM CITRATE
- SODIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 12539-146 | 12539-146-01, 12539-146-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| NAPHAZOLINE HYDROCHLORIDE | MZ1131787D | ACTIB |
| SODIUM BISULFITE | TZX5469Z6I | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NAFASOLINA | NAPHAZOLINE HYDROCHLORIDE | Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | 30cade3d-208f-8594-e063-6394a90ad2a0 | 2025-12-18 | Warnings | 12539-146-01 12539-146-02 12539-146 12539014602 12539014601 463c40c9-6e49-e804-e063-6394a90a3db8 30cade3d-208f-8594-e063-6394a90ad2a0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.