Darby Dental Supply, LLC
NDC labeler code: 66467
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.
Prescription medicines
- Lidocaine hydrochloride and epinephrineXylocaine, Lignospan Standard, Flavalta · 2 products
- Mepivacaine hydrochloridePolocaine, Polocaine-Mpf, Carbocaine · 1 product
- Chlorhexidine gluconatePeriogard Alcohol Free, Dash Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate 0.12% Oral Rinse · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 30, 2009 | ANDA088389 | Lidocaine hydrochloride and epinephrine LIGNOSPAN FORTE | Deproco |
| June 18, 2009 | ANDA077789 | Chlorhexidine gluconate CHLORHEXIDINE GLUCONATE | Pharmobedient |
| January 22, 1985 | ANDA088390 | Lidocaine hydrochloride and epinephrine LIGNOSPAN STANDARD | Deproco |
| October 10, 1984 | ANDA088387 | Mepivacaine hydrochloride SCANDONEST PLAIN | Deproco |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
October 31, 2025 · Class II · Ongoing · D-0231-2026 · Mepivacaine hydrochloride
Defective container: cracked/broken cartridges
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmac
2013
-
August 14, 2013 · Class II · Terminated · D-923-2013 · Lidocaine hydrochloride and epinephrine
Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO
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
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026