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Nasal Four
phenylephrine hydrochloride · Nasal Four is an over-the-counter drug containing phenylephrine hydrochloride, made by HyVee Inc.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Nasal
- Manufacturers
- 1
• temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies
Drug facts
- Generic name
- phenylephrine hydrochloride
- Active ingredients
- Phenylephrine Hydrochloride
- Dosage forms
- Spray
- Label holder
- HyVee Inc
- FDA application
- M012
- Label updated
- 04/01/2026
Active ingredients
Phenylephrine hydrochloride 1%
Purpose
Nasal decongestant
Uses
- Temporarily relieves nasal congestion due to:
- Common cold
- Hay fever
- Upper respiratory allergies
Directions
- Adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
- Children under 12 years: ask a doctor
- Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
Ask a doctor before use
- Heart disease
- Diabetes
- Thyroid disease
- High blood pressure
- 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
- Use only as directed
- 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. (1-800-222-1222)
Other information
- Store at 20°-25°C (68°-77°F)
Inactive ingredients
Benzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate
Questions?
1-800-289-8343
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Spray | 1 g/100mL | nasal | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 3,734 reports that list phenylephrine 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
- Off label use1,329
- Pemphigus1,039
- Joint swelling1,005
- Pain981
- Drug ineffective970
- Rheumatoid arthritis960
- Infusion related reaction953
- Systemic lupus erythematosus948
- Pericarditis944
- Maternal exposure during pregnancy940
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- HyVee IncShown hereM012 · Label 04/01/2026 · NDC 42507-648Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing05/06/2026Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03Wells Pharma of Houston LLC · cGMP deviations.
- Class IIDrugOngoing12/17/2025Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL...Fagron Compounding Services · Incorrect Product Formulation
- Class IIDrugOngoing12/10/2025Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave...Park Avenue Compounding · CGMP Deviations
- Class IIIDrug07/30/2025Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL...Imprimis NJOF, LLC · Sub-Potent Drug: Subpotent assay results during stability testing.
- Class IIDrugOngoing04/30/2025PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only...Denver Solutions, LLC DBA Leiters Health · Lack of Assurance of Sterility: Leaking/damaged syringes.
Nasal Four: common questions
- What is Nasal Four used for?
- • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies
- Is Nasal Four a prescription drug?
- No. Nasal Four is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Nasal Four?
- Yes. Other FDA-listed products with the same active ingredients include Nasal, Nasal Decongestant PE, Nasal Decongestant PE Maximum Strength, Equate Nasal.
- Who makes Nasal Four?
- HyVee Inc lists Nasal Four with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/01/2026 · Label text is shown as published by the manufacturer. Not medical advice