Home DailyMed 85791e13-4103-19fe-e053-2991aa0a647f BD ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator with Sterile Solution Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer CareFusion 213, LLC | Becton, Dickinson and Company
Effective date 2025-10-17
Label type HUMAN OTC DRUG LABEL
Version 8
Source full-release
Hydrated at 2026-06-01 01:40:19 Label at a glance# Product ChloraPrep One-Step
Active ingredient CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL
Label structure 15 sections
Dosage and administration • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns • use in a well ventilated area • maximal treatment area for one applicator is approximately 13.2 in. x 13.2 in. (1126 cm 2 ). Do not use 26-mL applicator for area smaller than 8.4 in. x 8.4 in . Use a smaller applicator instead. • do not use 26-mL applicator for head and neck surgery • remo...
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 998282 ChloraPrep 2 % / 70 % Topical Solution PSN 8 858726 chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution PSN 8 998282 chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep] SBD 8 858726 chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution SCD 8 998282 ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution SY 8 858726 chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution SY 8
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54365-400-38 ChloraPrep One-Step 1 in 1 POUCH SOLUTION 1 8 54365-400-38 ChloraPrep One-Step 26 mL in 1 APPLICATOR SOLUTION 26 8
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 7 matching rows.
ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol WATER CHLORHEXIDINE GLUCONATE CHLORHEXIDINE ISOPROPYL ALCOHOL FD&C YELLOW NO. 6 Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 4 matching rows.
Older Hydrated Versions# Version, Effective date, Source table Version Effective date Source Hydrated 7 2025-07-02 full-release 2026-06-01 01:06:23
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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-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 · 129 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 2026-09-14 22:38:34 2026-08 N021555-001 CHLORAPREP ONE-STEP SEPP 2%;70% (0.67ML) SWAB / TOPICAL RLD, RS 2002-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021555-002 CHLORAPREP SINGLE SWABSTICK 2%;70% (1.75ML) SWAB / TOPICAL RLD, RS 2005-05-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021555-003 CHLORAPREP TRIPLE SWABSTICK 2%;70% (5.25ML) SWAB / TOPICAL RLD, RS 2009-06-10 84e616aacf4f…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…
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 · 11 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 (package): 54365-400-38 ndc (product): 54365-400 ndc11 (package): 54365040038 spl id: 415fe396-0d2b-40a9-e063-6294a90a8462 spl set id: 85791e13-4103-19fe-e053-2991aa0a647f 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 One-Step CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL CareFusion 213 LLC f06e4f9d-6cef-b57a-e053-2a95a90a7337 2025-07-03 Warnings Exact identifier ndc (product): 54365-400
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.