Quick answers
- What is Flavalta?
- Flavalta is a brand name of Lidocaine hydrochloride and epinephrine, a prescription medicine. The FDA NDC Directory lists 1 Flavalta product in 1 strength and form.
- Who makes Flavalta?
- Deproco holds the FDA application for Flavalta (NDA216564, approved March 19, 2026).
- Is there a generic or store brand of Flavalta?
- Yes. The FDA NDC Directory lists 10 other products with the same active ingredients, strength and form as a Flavalta product, 10 of them generic. Ask your pharmacist whether one is right for you.
- Has Flavalta been recalled?
- No recall linked to Flavalta products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Flavalta is
Each Flavalta 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 hydrochloride and epinephrine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| epinephrine bitartrate 0.01 mg/mL · lidocaine hydrochloride 20 mg/mL injection, solution (submucosal) | Flavalta | 10 products, 9 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lidocaine hydrochloride and epinephrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA216564 | Deproco | March 19, 2026 | 1 |
Companies that list Flavalta
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Flavalta products.
- Septodont, Inc.1 product
Recalls
No recall linked to Flavalta 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.