Application 021555

Type: NDA
Sponsor: BECTON DICKINSON CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORAPREP ONE-STEP SEPP	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	SWAB;TOPICAL	2%;70% (0.67ML)	Yes	Yes
002	CHLORAPREP SINGLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	SWAB;TOPICAL	2%;70% (1.75ML)	Yes	Yes
003	CHLORAPREP TRIPLE SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	SWAB;TOPICAL	2%;70% (5.25ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021555-001	CHLORAPREP ONE-STEP SEPP	2%;70% (0.67ML)	SWAB / TOPICAL	RLD, RS	2002-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021555-002	CHLORAPREP SINGLE SWABSTICK	2%;70% (1.75ML)	SWAB / TOPICAL	RLD, RS	2005-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021555-003	CHLORAPREP TRIPLE SWABSTICK	2%;70% (5.25ML)	SWAB / TOPICAL	RLD, RS	2009-06-10	`caaa826d4ba7…`
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…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORAPREP	CHLORAPREP	HF Acquisition Co LLC, DBA HealthFirst	44fe08e0-4e9c-8bd6-e063-6394a90a0e2b	2025-12-02	Warnings	Exact identifier application applno (NDA): 021555 application number: NDA021555
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85291b2b-40b9-07fa-e053-2a91aa0a84e4	2025-11-04	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85416361-90b5-3efa-e053-2a91aa0af431	2025-11-03	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8528a4f5-5ff4-45f3-e053-2991aa0a804c	2025-11-03	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8529596f-37e4-c44e-e053-2a91aa0ad014	2025-10-30	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8578da30-a155-2505-e053-2991aa0a2c04	2025-10-29	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8541f219-c060-399a-e053-2991aa0ab05c	2025-10-24	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	2025-10-23	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85790749-5a95-7f18-e053-2a91aa0a1a02	2025-10-17	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85791e13-4103-19fe-e053-2991aa0a647f	2025-10-17	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85794f6b-d1ea-40f9-e053-2991aa0a8823	2025-10-17	Warnings	Exact identifier ndc (product): 54365-400
ChloraPrep Swabstick	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213 LLC	1666069b-38f6-bfde-e063-6394a90ad1b8	2025-10-17	Warnings	Exact identifier application applno (NDA): 021555 application number: NDA021555
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213 LLC	f06e4f9d-6cef-b57a-e053-2a95a90a7337	2025-07-03	Warnings	Exact identifier application applno (NDA): 021555 application number: NDA021555 ndc (product): 54365-400

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current
54365-400	ChloraPrep One-Step	Chlorhexidine gluconate and isopropyl alcohol	CareFusion 213 LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75331	SUPPL	2023-08-31
75330	SUPPL	2023-08-31
50913	SUPPL	2017-12-27
49823	SUPPL	2017-09-21
49755	SUPPL	2017-09-12
37218	SUPPL	2014-07-31
28109	SUPPL	2014-07-01
37216	SUPPL	2014-01-15
15775	SUPPL	2014-01-15
37217	SUPPL	2013-11-20
5732	SUPPL	2013-10-11
5731	SUPPL	2012-08-17
5730	SUPPL	2012-08-17
5729	SUPPL	2010-07-23
28106	SUPPL	2009-06-16
37215	SUPPL	2007-08-14
28108	SUPPL	2007-08-14
28107	SUPPL	2006-12-28
5728	SUPPL	2006-01-06
5727	SUPPL	2005-05-17
42210	ORIG	2005-01-11
15774	ORIG	2002-10-07
5726	ORIG	2002-10-07