Akten is a brand name of Lidocaine, a prescription medicine. The FDA NDC Directory lists 1 Akten product in 1 strength and form.

Thea Pharma holds the FDA application for Akten (NDA022221, approved October 7, 2008).

Is there a generic or store brand of Akten?

Other products of Lidocaine are listed with the FDA, but none in exactly the same strength and form as a Akten product.

Akten (Lidocaine): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Akten?: Akten is a brand name of Lidocaine, a prescription medicine. The FDA NDC Directory lists 1 Akten product in 1 strength and form.
Who makes Akten?: Thea Pharma holds the FDA application for Akten (NDA022221, approved October 7, 2008).
Is there a generic or store brand of Akten?: Other products of Lidocaine are listed with the FDA, but none in exactly the same strength and form as a Akten product.
Has Akten been recalled?: No recall linked to Akten products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Akten is

Each Akten 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.

Lidocaine · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
lidocaine hydrochloride anhydrous 35 mg/mL gel (ophthalmic)	Akten	None listed	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lidocaine →

FDA approval

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

FDA applications of Akten products (Drugs@FDA)
Application	Holder	First approved	Products
NDA022221	Thea Pharma	October 7, 2008	1

Companies that list Akten

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Akten products.

Thea Pharma Inc.1 product

Recalls

No recall linked to Akten products (by their NDC code or label) appears in the FDA enforcement reports.

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.

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Akten