Checked
Afrin
oxymetazoline hydrochloride · Afrin is an over-the-counter drug containing oxymetazoline hydrochloride, made by Navajo Manufacturing Company Inc..
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
- + 1 repackager labels
temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIIDrugOngoing07/03/2024SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to...Neilmed Pharmaceuticals Inc · Sub-potent Drug
- Class IIDrugOngoing01/10/2024Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle...Seaway Pharma Inc. · 3 products · CGMP Deviations: Firm reported possible microbial contamination in...
- Class IIDrug10/25/2023Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx...Pine Pharmaceuticals, LLC · Lack of Assurance of Sterility
- Class IIDrugOngoing08/31/2022AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dollar Stores 04/30/2022 through...Family Dollar Stores, Llc. · CGMP Deviations: product held outside appropriate storage...
- Class IIDrug03/02/2022Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30...Perrigo Company PLC · 27 products · CGMP Deviations: Products were manufactured with contaminated...
Active ingredients
Oxymetazoline hydrochloride 0.05% Purpose Nasal decongestant
Purpose
Nasal decongestant
Uses
Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely
Directions
Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: ask a doctor. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Warnings
Ask a doctor before use if you have
- Heart disease
- High blood pressure
- Diabetes
- Thyroid disease
- Trouble urinating due to an enlarged prostate gland When using this product do not use more than directed do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Ask a doctor before use
- Heart disease
- High blood pressure
- Diabetes
- Thyroid disease
- Trouble urinating due to an enlarged prostate gland
When using this product
Do not use more than directed do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur use of this container by more than one person may spread infection
Stop use and ask a doctor
Symptoms persist
Pregnancy or breastfeeding
Ask a health professional before use.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive ingredients
Benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic
Questions?
Call 1-800-317-2165, M-F 8am-5pm
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Spray | .05 g/100mL | topical | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 5,039 reports that list oxymetazoline hydrochloride, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug dependence1,129
- Drug ineffective375
- Anosmia285
- Dyspnea262
- Headache206
- Product use issue202
- Fatigue186
- Nausea184
- Ageusia182
- Diarrhea158
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label · 1 from repackagers
Repackager labels (1)
- Navajo Manufacturing Company Inc.10/02/2024
Afrin: common questions
- What is Afrin used for?
- temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely
- Is Afrin a prescription drug?
- No. Afrin is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Afrin?
- Yes. Other FDA-listed products with the same active ingredients include nasal, Oxymetazoline Hydrochloride, No Drip Nasal Mist, 12 Hour Original Nasal Decongestant.
- Who makes Afrin?
- Navajo Manufacturing Company Inc. lists Afrin with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 10/02/2024 · Label text is shown as published by the manufacturer. Not medical advice