DrugDashboards

ChloraPrep One-Step

chlorhexidine gluconate and isopropyl alcohol · CHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mL · Solution · Topical · CareFusion 213, LLC

NDC 54365-0400-30 · 20 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. 3 Class II recalls hit this product in the past year (CareFusion 213, LLC).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Regulatory

Application
NDA020832
TE code
—
Approval date
Jul 14, 2000
Patents / exclusivity
3 patents, 0 exclusivities
TypeNumber / codeExpires
patent7422388Apr 25, 2027
patent7422388Apr 25, 2027
patent7422388Apr 25, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJun 11, 2026
    CareFusion 213, LLC — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
  • Class II · OngoingMay 28, 2026
    CareFusion 213, LLC — Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
  • Class I · OngoingMay 28, 2026
    CareFusion 213, LLC — Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Manufacturers of chlorhexidine gluconate and isopropyl alcohol (Solution)

LabelerStrengthFirst seenLast seen
CareFusion 213, LLCCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Sep 3, 2026
Professional Disposables International, Inc.CHLORHEXIDINE GLUCONATE 31.5 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Sep 3, 2026
C.R. BardCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Sep 2, 2026
CareFusion 213, LLCISOPROPYL ALCOHOL .7 mL/mL; CHLORHEXIDINE GLUCONATE 20 mg/mLAug 26, 2026Sep 2, 2026
CareFusion 213 LLCCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Aug 31, 2026
Solventum US LLCCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Aug 28, 2026
CareFusion 213, LLCISOPROPYL ALCOHOL 20 mg/mL; CHLORHEXIDINE GLUCONATE .7 mL/mLJul 22, 2026Aug 19, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "ChloraPrep One-Step — NDC 54365-0400-30," retrieved September 3, 2026, https://drugdashboards.com/drug/54365040030.

Free to cite with attribution — see how the data is put together.