Prescription medicine
Epinastine First approved as Elestat
Epinastine (Elestat) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $14.33 per mL (Epinastine HCl 0.05% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the epinastine FDA label on DailyMed (effective March 22, 2025, Somerset Therapeutics, LLC); the NDA 21565 record on Drugs@FDA; every epinastine label on DailyMed.
Highlights of the record
FDA label of March 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageEpinastine HCl ophthalmic solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
Forms and strengths
- 0.5 mg/ml
Solution/ drops.
On the market
- Earliest approval on file
- October 16, 2003 Elestat, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first March 14, 2011; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $14.33 per mL Epinastine HCl 0.05% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,128 through July 30, 2026
What is epinastine used for?
From the label: indications and usageEpinastine HCl ophthalmic solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
FDA pharmacologic class: Adrenergic Receptor Agonist and Histamine-1 Receptor Inhibitor.
Source: FDA drug label (EPINASTINE HYDROCHLORIDE), Somerset Therapeutics, LLC, effective March 22, 2025 (SPL set 0d4ee45c-e58f-4b7c-b389-898f5c27f54d), via openFDA; the full label on DailyMed
Is there a generic for epinastine (Elestat)?
The FDA approved the first generic epinastine on March 14, 2011. 6 generic applications are approved; 1 of them 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 epinastine from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2011 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for epinastine (Elestat)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $14.33 per mL (Epinastine HCl 0.05% eye drops), up 6% from $13.52 on October 8, 2025. 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.
- Epinastine HCl 0.05% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Epinastine HCl 0.05% eye drops | Generic | $14.33 per mL | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the epinastine label say about other medicines?
The epinastine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Benzalkonium | warnings and precautions | The preservative in epinastine HCl, benzalkonium chloride, may be absorbed by soft contact lenses. |
Source: FDA drug label (EPINASTINE HYDROCHLORIDE), Somerset Therapeutics, LLC, effective March 22, 2025 (SPL set 0d4ee45c-e58f-4b7c-b389-898f5c27f54d), via openFDA; the full label on DailyMed
What do FAERS reports show for epinastine?
The FDA Adverse Event Reporting System holds 1,128 reports that list epinastine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 106 are coded as a death and 443 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?
- Other histamine-1 receptor inhibitors
- the pharmacologic class, with prices and generics
- Epinastine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other