chloraprep swabstick

Generic: chlorhexidine gluconate and isopropyl alcohol

Labeler: carefusion 213 llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name chloraprep swabstick
Generic Name chlorhexidine gluconate and isopropyl alcohol
Labeler carefusion 213 llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

chlorhexidine gluconate 20 mg/mL, isopropyl alcohol .7 mL/mL

Manufacturer
CareFusion 213 LLC

Identifiers & Regulatory

Product NDC 54365-401
Product ID 54365-401_41609458-1100-f069-e063-6294a90a6573
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021555
Listing Expiration 2026-12-31
Marketing Start 2024-05-13

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54365401
Hyphenated Format 54365-401

Supplemental Identifiers

RxCUI
1918214
UNII
MOR84MUD8E ND2M416302

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name chloraprep swabstick (source: ndc)
Generic Name chlorhexidine gluconate and isopropyl alcohol (source: ndc)
Application Number NDA021555 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • .7 mL/mL
source: ndc
Packaging
  • 48 POUCH in 1 CARTON (54365-401-28) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR
  • 40 POUCH in 1 CARTON (54365-401-29) / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATOR
source: ndc

Packages (2)

54365-401-28 48 POUCH in 1 CARTON (54365-401-28) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR 54365-401-29 40 POUCH in 1 CARTON (54365-401-29) / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATOR

Ingredients (2)

chlorhexidine gluconate (20 mg/mL) isopropyl alcohol (.7 mL/mL)

Linked Drug Pages (1)

ChloraPrep Swabstick ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "41609458-1100-f069-e063-6294a90a6573", "openfda": {"unii": ["MOR84MUD8E", "ND2M416302"], "rxcui": ["1918214"], "spl_set_id": ["1666069b-38f6-bfde-e063-6394a90ad1b8"], "manufacturer_name": ["CareFusion 213 LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "48 POUCH in 1 CARTON (54365-401-28)  / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR", "package_ndc": "54365-401-28", "marketing_start_date": "20240513"}, {"sample": false, "description": "40 POUCH in 1 CARTON (54365-401-29)  / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATOR", "package_ndc": "54365-401-29", "marketing_start_date": "20240513"}], "brand_name": "ChloraPrep Swabstick", "product_id": "54365-401_41609458-1100-f069-e063-6294a90a6573", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "54365-401", "generic_name": "Chlorhexidine gluconate and isopropyl alcohol", "labeler_name": "CareFusion 213 LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ChloraPrep Swabstick", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "20 mg/mL"}, {"name": "ISOPROPYL ALCOHOL", "strength": ".7 mL/mL"}], "application_number": "NDA021555", "marketing_category": "NDA", "marketing_start_date": "20240513", "listing_expiration_date": "20261231"}