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Drug company (FDA labeler)

Benco Dental

NDC labeler code: 66975

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

6Products (NDC)

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
September 30, 2009ANDA088389 Lidocaine hydrochloride and epinephrine
LIGNOSPAN FORTE
Deproco
June 18, 2009ANDA077789 Chlorhexidine gluconate
CHLORHEXIDINE GLUCONATE
Pharmobedient
April 3, 2000NDA020971 Articaine hydrochloride and epinephrine
SEPTOCAINE
Deproco
January 22, 1985ANDA088390 Lidocaine hydrochloride and epinephrine
LIGNOSPAN STANDARD
Deproco
October 10, 1984ANDA088387 Mepivacaine hydrochloride
SCANDONEST PLAIN
Deproco

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2025

  1. October 31, 2025 · Class II · Ongoing · D-0232-2026 · Mepivacaine hydrochloride

    Defective container: cracked/broken cartridges

    Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 29

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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