What is NDC 54365-401?

54365-401 is the product NDC for ChloraPrep Swabstick, Chlorhexidine gluconate 20 mg/mL; Isopropyl alcohol .7 mL/mL solution, listed with the FDA by CareFusion 213 LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

ChloraPrep Swabstick (Chlorhexidine gluconate and isopropyl alcohol).

What is the active ingredient?

Chlorhexidine gluconate, Isopropyl alcohol.

CareFusion 213 LLC, NDC labeler code 54365. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for ChloraPrep Swabstick?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

ChloraPrep Swabstick NDC 54365-401

NDC codes

FDA NDC Directory

Product NDC (as listed)54365-401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54365-0401Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
54365-401-28	5436504012854365040128	48 POUCH in 1 CARTON (54365-401-28) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATORMarketed from May 13, 2024
54365-401-29	5436504012954365040129	40 POUCH in 1 CARTON (54365-401-29) / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATORMarketed from May 13, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): ChloraPrep Swabstick
Generic name (nonproprietary): chlorhexidine gluconate and isopropyl alcohol
Active ingredients: Chlorhexidine gluconate — 20 mg/mLIsopropyl alcohol — .7 mL/mL
Dosage form: Solution
Route: Topical
Labeler: CareFusion 213 LLCNDC labeler code 54365
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021555
Marketing start: May 13, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cell Wall Integrity (Physiologic effect)
Identifiers: Product ID 54365-401_41609458-1100-f069-e063-6294a90a6573SPL ID 41609458-1100-f069-e063-6294a90a6573SPL set ID 1666069b-38f6-bfde-e063-6394a90ad1b8RxCUI 1918214UNII MOR84MUD8E, ND2M416302

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454365040128 followed by a unit qualifier and the quantity

Package 54365-0401-28. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 17, 2025.

Indications (excerpt from the label)

Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54365-401

What is NDC 54365-401?: 54365-401 is the product NDC for ChloraPrep Swabstick, Chlorhexidine gluconate 20 mg/mL; Isopropyl alcohol .7 mL/mL solution, listed with the FDA by CareFusion 213 LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: ChloraPrep Swabstick (Chlorhexidine gluconate and isopropyl alcohol).
What is the active ingredient?: Chlorhexidine gluconate, Isopropyl alcohol.
Who is the labeler?: CareFusion 213 LLC, NDC labeler code 54365. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ChloraPrep Swabstick?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 021555

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021555
Product	Strength	Form · route	Labeler	Product NDC
Chloraprep	Isopropyl alcohol .7 mL/mL; Chlorhexidine gluconate 20 mg/mL	SolutionTopical	HF Acquisition Co LLC, DBA HealthFirst	51662-1675