Zicam Intense Sinus Relief

OXYMETAZOLINE HYDROCHLORIDE NASAL HUMAN OTC DRUG

Zicam Intense Sinus Relief is an FDA drug label for the active ingredient OXYMETAZOLINE HYDROCHLORIDE manufactured by Church & Dwight Co., Inc. administered by NASAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260831.

Generic name
OXYMETAZOLINE HYDROCHLORIDE
Manufacturer
Church & Dwight Co., Inc.
Product type
HUMAN OTC DRUG
Route
NASAL
Dosage form
N/A
NDC
10237-471
Application
M012
Label effective
20260831

About this product

Zicam Intense Sinus Relief is an FDA-registered drug product whose active ingredient is OXYMETAZOLINE HYDROCHLORIDE. It is labelled by Church & Dwight Co., Inc. taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 10237-471, application M012, label effective 20260831. It is one of 44 FDA drug label records sharing the active ingredient OXYMETAZOLINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing OXYMETAZOLINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, nasal congestion, common cold, hay fever, upper respiratory, pressure helps, passages shrinks, swollen membranes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Oxymetazoline hydrochloride 0.05%

Indications & Usage

Uses temporarily relieves nasal congestion due to: the common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure helps clear nasal passages shrinks swollen membranes

Dosage & Administration

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 use pump: to open, hold the actuator to squeeze and turn cap hold with thumb at bottom of bottle and nozzle between fingers before using the first time, prime pump by depressing several times place tip of nozzle just past nasal opening (approximately 1/8") pump 2 or 3 times in each nostril without tilting your head. Sniff deeply. wipe nozzle clean after use to close, turn cap until it 'clicks'

Warnings

Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes 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 result 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.

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OXYMETAZOLINE HYDROCHLORIDE

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How products containing OXYMETAZOLINE HYDROCHLORIDE compare

FDA lists 44 drug label records with OXYMETAZOLINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — BEST CHOICE (VALU MERCHANDISERS COMPANY) 5
— — CVS PHARMACY, INC. 3
— — Procter & Gamble Manufacturing GmbH 3
— — WinCo FOODS, LLC 3
— — AMERISOURCE BERGEN 2

Recall and safety notices

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0790-2026 Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205. Church & Dwight Co., Inc. Class II Ongoing 20260902
D-0095-2026 ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 Church & Dwight Co., Inc. Class II Ongoing 20251029

Frequently asked questions

What is Zicam Intense Sinus Relief used for?
Uses temporarily relieves nasal congestion due to: the common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure helps clear nasal passages shrinks swollen membranes

Who makes Zicam Intense Sinus Relief?
Church & Dwight Co., Inc. is the labeler of record for Zicam Intense Sinus Relief. 44 FDA label records share the active ingredient OXYMETAZOLINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Zicam Intense Sinus Relief come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Zicam Intense Sinus Relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing OXYMETAZOLINE HYDROCHLORIDE?
Yes. 44 FDA drug label records list OXYMETAZOLINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Zicam Intense Sinus Relief been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.