FDA.reportPublic FDA data

Application 021555

Type
NDA
Sponsor
BECTON DICKINSON CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORAPREP ONE-STEP SEPPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL2%;70% (0.67ML)YesYes
002CHLORAPREP SINGLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL2%;70% (1.75ML)YesYes
003CHLORAPREP TRIPLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL2%;70% (5.25ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021555-001CHLORAPREP ONE-STEP SEPPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07
N021555-002CHLORAPREP SINGLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10
N021555-003CHLORAPREP TRIPLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10

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 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07782e0a99824c…
2021-12-28 21:50 UTC2021-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10782e0a99824c…
2021-12-28 21:50 UTC2021-12N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-075aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-105aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-078869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-108869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-073f01610625f2…
2019-12-14 00:12 UTC2019-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-103f01610625f2…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORAPREPCHLORAPREPHF Acquisition Co LLC, DBA HealthFirst44fe08e0-4e9c-8bd6-e063-6394a90a0e2b2025-12-02WarningsExact identifier
application applno (NDA): 021555
application number: NDA021555
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85291b2b-40b9-07fa-e053-2a91aa0a84e42025-11-04WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85416361-90b5-3efa-e053-2a91aa0af4312025-11-03WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8528a4f5-5ff4-45f3-e053-2991aa0a804c2025-11-03WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541f219-c060-399a-e053-2991aa0ab05c2025-10-24WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541a1ed-2a92-1fab-e053-2a91aa0a29d12025-10-23WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85790749-5a95-7f18-e053-2a91aa0a1a022025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85791e13-4103-19fe-e053-2991aa0a647f2025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85794f6b-d1ea-40f9-e053-2991aa0a88232025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLC1666069b-38f6-bfde-e063-6394a90ad1b82025-10-17WarningsExact identifier
application applno (NDA): 021555
application number: NDA021555
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLCf06e4f9d-6cef-b57a-e053-2a95a90a73372025-07-03WarningsExact identifier
application applno (NDA): 021555
application number: NDA021555
ndc (product): 54365-400

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent
54365-400ChloraPrep One-StepChlorhexidine gluconate and isopropyl alcoholCareFusion 213 LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75331SUPPL 2023-08-31
75330SUPPL 2023-08-31
50913SUPPL2017-12-27
49823SUPPL2017-09-21
49755SUPPL2017-09-12
37218SUPPL2014-07-31
28109SUPPL2014-07-01
37216SUPPL2014-01-15
15775SUPPL2014-01-15
37217SUPPL2013-11-20
5732SUPPL2013-10-11
5731SUPPL2012-08-17
5730SUPPL2012-08-17
5729SUPPL2010-07-23
28106SUPPL2009-06-16
37215SUPPL2007-08-14
28108SUPPL2007-08-14
28107SUPPL2006-12-28
5728SUPPL2006-01-06
5727SUPPL2005-05-17
42210ORIG2005-01-11
15774ORIG2002-10-07
5726ORIG2002-10-07