Over-the-counter medicine
Naphazoline and pheniramine Brand names: Eye, Opcon-A, Naphcon, Visine
Naphazoline and pheniramine (Eye) is an over-the-counter medicine with an FDA approval on record since 1994. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $0.557 per mL (Naphcon-a eye drops).
- Generic approved
- Over the counter
Check it at the source: the naphazoline and pheniramine FDA label on DailyMed (effective March 20, 2026, Bausch & Lomb Incorporated); the NDA 20065 record on Drugs@FDA; every naphazoline and pheniramine label on DailyMed.
Highlights of the record
FDA label of March 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetemporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander
Forms and strengths
- 0.25 mg/ml / 3 mg/ml
- 0.2675 mg/ml / 3.15 mg/ml
- 0.27 mg/ml / 3.15 mg/ml
Solution/ drops.
On the market
- Earliest approval on file
- June 8, 1994 Opcon-A, Bausch And Lomb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first September 27, 2010; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 1 under generic applications, 9 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.557 per mL Naphcon-a eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest June 29, 2022
- FAERS reports
- 1,943 through July 30, 2026
What is naphazoline and pheniramine used for?
From the label: indications and usagetemporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander
Source: FDA drug label (Opcon-A), Bausch & Lomb Incorporated, effective March 20, 2026 (SPL set 2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5), via openFDA; the full label on DailyMed
Is there a generic for naphazoline and pheniramine (Eye)?
The FDA approved the first generic naphazoline and pheniramine on September 27, 2010. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists naphazoline and pheniramine from 1 labeler under a generic (ANDA) application and from 9 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
- 1994 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for naphazoline and pheniramine (Eye)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.557 per mL (Naphcon-a eye drops), about the same as a year earlier. 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.
- Naphcon-a eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Naphcon-a eye drops | Brand | $0.557 per mL | n/a | +0.6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has naphazoline and pheniramine been recalled?
The FDA's Enforcement Report lists 1 recall naming naphazoline and pheniramine since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 29, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | CGMP Deviations: products were stored outside the drug label specifications. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for naphazoline and pheniramine?
The FDA Adverse Event Reporting System holds 1,943 reports that list naphazoline and pheniramine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 29 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
What next?
- Naphazoline and pheniramine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other