Over-the-counter medicine
Tetrahydrozoline
Tetrahydrozoline is an over-the-counter medicine. No generic is listed; pharmacies paid $0.0969 per mL (Qc eye drops 0.05%) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the tetrahydrozoline FDA label on DailyMed (effective December 30, 2025); every tetrahydrozoline label on DailyMed.
Highlights of the record
FDA label of December 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagerelieves redness of the eye due to minor eye irritations
Forms and strengths
- 0.05 g/100ml
- 0.5 mg/ml
Solution/ drops; solution; liquid.
On the market
- Generic approvals
- 1 first November 30, 1979; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0969 per mL Qc eye drops 0.05%
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest July 17, 2014; 4 more by firms not listed as its makers
- FAERS reports
- 294 through July 30, 2026
What is tetrahydrozoline used for?
From the label: indications and usagerelieves redness of the eye due to minor eye irritations
Source: FDA drug label (Foster and Thrive Original Formula Eye Drops), Strategic Sourcing Services LLC, effective December 30, 2025 (SPL set 002da62b-aec6-8e2a-e063-6294a90a5efc), via openFDA; the full label on DailyMed
Is there a generic for tetrahydrozoline?
The FDA approved the first generic tetrahydrozoline on November 30, 1979. 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.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tetrahydrozoline?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0969 per mL (Qc eye drops 0.05%), down 24% from $0.127 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.
- Qc eye drops 0.05% (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Qc eye drops 0.05% | Generic | $0.0969 per mL | n/a | -24% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tetrahydrozoline been recalled?
The FDA's Enforcement Report lists 5 recalls naming tetrahydrozoline since 2014: 0 Class I (the most serious), 4 Class II, 1 Class III; 2 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of tetrahydrozoline 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 |
|---|---|---|---|
| March 3, 2026 | Class II | K.C. Pharmaceuticals, Inc not a listed maker | Lack of Assurance of Sterility |
| June 13, 2023 | Class II | K.C. Pharmaceuticals, Inc not a listed maker | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. |
| December 4, 2014 | Class III | K C Pharmaceuticals Inc not a listed maker | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. |
| July 18, 2014 | Class II | Spectrum Laboratory Products not a listed maker | CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. |
| July 17, 2014 | Class II | SST Corporation | CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for tetrahydrozoline?
The FDA Adverse Event Reporting System holds 294 reports that list tetrahydrozoline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 65 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tetrahydrozoline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other