Quick answers
- What is TheraTears?
- TheraTears is a brand name of Carboxymethylcellulose, an over-the-counter medicine. The FDA NDC Directory lists 6 TheraTears products in 5 strengths and forms.
- Who makes TheraTears?
- Medtech Products Inc lists 6 of the 6 TheraTears products in the FDA NDC Directory.
- Is there a generic or store brand of TheraTears?
- Yes. The FDA NDC Directory lists 14 other products with the same active ingredients, strength and form as a TheraTears product, 14 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has TheraTears been recalled?
- FDA enforcement reports list 1 recall of TheraTears products; the newest started September 8, 2021. A recall usually concerns specific lots, not every product.
What TheraTears is
Each TheraTears product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Carboxymethylcellulose · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| carboxymethylcellulose sodium 2.5 mg/mL solution/ drops (ophthalmic) | TheraTears Lubricant | None listed | DailyMed |
| carboxymethylcellulose sodium 5 mg/mL solution/ drops (ophthalmic) | TheraTears Dry and Tired | 14 products, 11 companies | DailyMed |
| carboxymethylcellulose sodium, unspecified 2.5 mg/mL solution/ drops (ophthalmic) | TheraTears Extra | None listed | — |
| carboxymethylcellulose sodium, unspecified form 10 mg/mL gel (ophthalmic) | TheraTears | None listed | DailyMed |
| carboxymethylcellulose sodium, unspecified form 2.5 mg/mL solution/ drops (ophthalmic) | TheraTears Extra, TheraTears Lubricant | None listed | — |
Its page quotes the Drug Facts label and lists every brand and store brand: Carboxymethylcellulose →
FDA approval
TheraTears products are sold under an FDA over-the-counter monograph: rules that set the allowed active ingredients, strengths and label wording, so these products do not need an individual FDA approval.
Companies that list TheraTears
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of TheraTears products.
- Medtech Products Inc6 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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September 8, 2021 · Class II · Terminated · D-0717-2022
Lack of Assurance of Sterility
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30 — Akorn, Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.