Home NDC 54365-401 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021555-001 CHLORAPREP ONE-STEP SEPP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 N021555-002 CHLORAPREP SINGLE SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 N021555-003 CHLORAPREP TRIPLE SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base ChloraPrep Swabstick
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORHEXIDINE GLUCONATE 20 mg/mL ISOPROPYL ALCOHOL .7 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MOR84MUD8E Internal UNII lookup ND2M416302 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1918214 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54365-401-28 ChloraPrep Swabstick 1 in 1 POUCH SOLUTION 1 3 54365-401-28 ChloraPrep Swabstick 48 in 1 CARTON SOLUTION 48 3 54365-401-29 ChloraPrep Swabstick 3 in 1 POUCH SOLUTION 3 3 54365-401-29 ChloraPrep Swabstick 40 in 1 CARTON SOLUTION 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54365-401 CHLORAPREP SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC] 1 Current NDC, 4 package rows 20240513_1666069b-38f6-bfde-e063-6394a90ad1b8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54365-401-28 54365040128 48 POUCH in 1 CARTON (54365-401-28) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR 48 pouch 2024-05-13 No No Current 54365-401-29 54365040129 40 POUCH in 1 CARTON (54365-401-29) / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATOR 40 pouch 2024-05-13 No No Current