Drugplain

oxymetazoline hcl .05 g/100mL

oxymetazoline hydrochloride · SPRAY · Padagis Israel Pharmaceuticals Ltd

10 Recalls on Record
Plain English

oxymetazoline hcl is a spray containing oxymetazoline hydrochloride at .05 g/100mL, taken nasal. Manufactured by Padagis Israel Pharmaceuticals Ltd.

Key Facts

Brand Name
oxymetazoline hcl
Generic Name
oxymetazoline hydrochloride
NDC Code (Product)
45802-410
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Strength
.05 g/100mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
12/05/2005

Recall History

10 Recalls on Record
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class I08/03/2018

Product Quest Manufacturing LLC

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Edge Pharma, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue48 reports
diarrhoea46 reports
nausea46 reports
pain43 reports
anosmia35 reports
headache34 reports
product dose omission issue34 reports
drug ineffective33 reports
pruritus32 reports
dyspnoea29 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

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: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Warnings

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 (1-800-222-1222).

Frequently Asked Questions

What is oxymetazoline hcl used for?

oxymetazoline hcl contains oxymetazoline hydrochloride. It is a spray taken nasal. Consult your doctor for specific uses.

Is oxymetazoline hcl a controlled substance?

oxymetazoline hcl is not classified as a controlled substance by the DEA.

What is the generic name for oxymetazoline hcl?

The generic name for oxymetazoline hcl is oxymetazoline hydrochloride. There are 12 other brand versions of oxymetazoline hydrochloride.

What is the NDC code for oxymetazoline hcl .05 g/100mL?

The NDC (National Drug Code) for oxymetazoline hcl .05 g/100mL is 45802-410, listed by Padagis Israel Pharmaceuticals Ltd.