ChloraPrep Swabstick

Product NDC
54365-401
11-digit product format
543650401
Labeler code
54365
Product ID
54365-401_41609458-1100-f069-e063-6294a90a6573
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine gluconate and isopropyl alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
CareFusion 213 LLC
Application
NDA021555
Marketing category
NDA
Marketing start
2024-05-13
Substance
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Active strength
20; .7 mg/mL; mL/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ChloraPrep Swabstick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE20 mg/mL
ISOPROPYL ALCOHOL.7 mL/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E, ND2M416302
Rxcui1918214

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54365-401-28ChloraPrep Swabstick1 in 1 POUCHSOLUTION13
54365-401-28ChloraPrep Swabstick48 in 1 CARTONSOLUTION483
54365-401-29ChloraPrep Swabstick3 in 1 POUCHSOLUTION33
54365-401-29ChloraPrep Swabstick40 in 1 CARTONSOLUTION403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54365-401CHLORAPREP SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]1Current NDC, 4 package rows20240513_1666069b-38f6-bfde-e063-6394a90ad1b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1918214chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated PadPSN1666069b-38f6-bfde-e063-6394a90ad1b83
1918214chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated PadSCD1666069b-38f6-bfde-e063-6394a90ad1b83
1918214chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Medicated PadSY1666069b-38f6-bfde-e063-6394a90ad1b83
1918214chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical SwabSY1666069b-38f6-bfde-e063-6394a90ad1b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54365-401-285436504012848 POUCH in 1 CARTON (54365-401-28) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR48 pouch2024-05-13NoNoCurrent
54365-401-295436504012940 POUCH in 1 CARTON (54365-401-29) / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATOR40 pouch2024-05-13NoNoCurrent