Prescription and over-the-counter medicine
Oxymetazoline Brand names: Rhofade, Upneeq; first approved as Ocuclear
Oxymetazoline (Upneeq) is a prescription and over-the-counter medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $0.111 per mL (Nasal decongestant 0.05% spray) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $23.47 per gram (Rhofade 1% cream).
- Generic listed
Check it at the source: the oxymetazoline FDA label on DailyMed (effective July 13, 2026); the NDA 18471 record on Drugs@FDA; every oxymetazoline label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOxymetazoline Hydrochloride Cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Forms and strengths
- 1 mg/ml
- 1 g/100g
- 10 mg/g
Cream; solution/ drops.
On the market
- Earliest approval on file
- May 30, 1986 Ocuclear, Bayer Healthcare Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first October 4, 2021; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 1 under generic applications, 3 under brand applications, repackagers included; 86 more under the over-the-counter monograph, without an application
- Last listed patent
- December 16, 2039 Upneeq solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.111 per mL Nasal decongestant 0.05% spray
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2021 0 Class I among all firms' recalls; 28 more by firms not listed as its makers
- FAERS reports
- 6,779 through July 30, 2026
What is oxymetazoline used for?
From the label: indications and usageOxymetazoline Hydrochloride Cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Oxymetazoline Hydrochloride Cream is an alpha 1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Conditions named in the indications of oxymetazoline's FDA labels, with every medicine labeled for each:
From other oxymetazoline labelsCough and cold: Uses temporarily relief of nasal congestion due to the common cold hay fever other upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely
Allergies: upper respiratory allergies
FDA pharmacologic class: Vasoconstrictor.
Source: FDA drug label (Rhofade), Mayne Pharma, effective July 13, 2026 (SPL set 34298db6-647d-480d-88a8-dc53258a5164), via openFDA; the full label on DailyMed
Is there a generic for oxymetazoline (Upneeq)?
The FDA approved the first generic oxymetazoline on October 4, 2021. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists oxymetazoline from 1 labeler under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 14 patents for Upneeq solution/drops, the last expiring on December 16, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1986 earliest approval on file
- 2021 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for oxymetazoline (Upneeq)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.111 per mL (Nasal decongestant 0.05% spray), about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nasal decongestant 0.05% spray (generic)
- Rhofade 1% cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft nasal spray 0.05% | Generic | $0.0874 per mL | n/a | -5% |
| Gnp no drip nasal mist 0.05% | Generic | $0.0997 per mL | n/a | -11% |
| Gs nasal spray 0.05% | Generic | $0.0752 per mL | n/a | +3% |
| Gs no drip 0.05% nasal spray | Generic | $0.0752 per mL | n/a | +3% |
| Nasal decongestant 0.05% spray | Generic | $0.111 per mL | n/a | -0.8% |
| Nasal spray 0.05% | Generic | $0.0752 per mL | n/a | +3% |
| Nasal spray original 0.05% | Generic | $0.0752 per mL | n/a | +3% |
| No drip 0.05% nasal spray | Generic | $0.0752 per mL | n/a | +3% |
| Qc nasal spray 0.05% | Generic | $0.0752 per mL | n/a | +3% |
| Qc no drip nasal mist 0.05% | Generic | $0.0997 per mL | n/a | -11% |
| Rhofade 1% cream | Brand | $23.47 per gram | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has oxymetazoline been recalled?
The FDA's Enforcement Report lists 28 recalls naming oxymetazoline since 2021: 0 Class I (the most serious), 27 Class II, 1 Class III; 4 still ongoing. 28 of them are by firms that FDA's NDC Directory does not list as a maker of oxymetazoline and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 24, 2024 | Class III | Neilmed Pharmaceuticals Inc not a listed maker | Sub-potent Drug |
| December 28, 2023 | Class II | Seaway Pharma Inc. not a listed maker | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. … |
| October 26, 2021 | Class II | Perrigo Company PLC not a listed maker | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for oxymetazoline?
The FDA Adverse Event Reporting System holds 6,779 reports that list oxymetazoline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 165 are coded as a death and 708 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does oxymetazoline compare with medicines for the same use?
3 side-by-side pages set oxymetazoline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other vasoconstrictors
- the pharmacologic class, with prices and generics
- Oxymetazoline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other