McKesson
NDC labeler code: 63739
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
- 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 |
|---|---|---|---|
| June 18, 2009 | ANDA077789 | Chlorhexidine gluconate CHLORHEXIDINE GLUCONATE | Pharmobedient |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
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April 2, 2026 · Class II · Ongoing · D-0529-2026 · Lidocaine
Lack of Assurance of Sterility
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by:
2021
-
November 30, 2021 · Class II · Ongoing · D-0296-2022 · Lidocaine
Superpotent Drug: Minimally superpotent
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging,
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November 30, 2021 · Class I · Ongoing · D-0295-2022 · Lidocaine
Superpotent Drug
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging,
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October 12, 2021 · Class II · Terminated · D-0279-2022 · Lidocaine
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blv
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