ChloraPrep One-Step

Product NDC: 54365-400
11-digit product format: 543650400
Labeler code: 54365
Product ID: 54365-400_39077328-1d82-77ac-e063-6394a90a4d24
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: 2002-10-07
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 17 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54365-400		D	Discontinued by firm	2026-08-17
excluded product	product	54365-400		I	Inactivated by FDA	2026-08-17
excluded product	product	54365-400		I	Inactivated by FDA	2026-08-17
excluded product	product	54365-400		I	Inactivated by FDA	2026-08-17
excluded product	product	54365-400		I	Inactivated by FDA	2026-08-17
excluded product	product	54365-400		I	Inactivated by FDA	2026-08-17
excluded package	package	54365-400	54365-400-15	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-02	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-06	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-01	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-11	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-04	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-09	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-12	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-05	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-13	D	Discontinued by firm	2026-08-17
excluded package	package	54365-400	54365-400-14	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 127 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-11	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-14	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-12	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-09	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-13	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54365-400-06	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-11	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-14	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-12	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-09	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-13	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54365-400-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-11	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-14	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-12	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-09	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-13	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-15	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54365-400-06	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-11	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-14	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-12	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-09	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-13	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-15	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54365-400-06	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54365-400-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ChloraPrep One-Step
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858726	Internal RxNorm lookup
998282	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f06e4f9d-6cef-b57a-e053-2a95a90a7337	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
54365-400-01	2025-07-29	3b156c62-2b8f-fb37-e063-e6dba90a4e07	ChloraPrep® Clear 3mL Non-Sterile Applicator
54365-400-02	2025-07-29	3b156c62-28c1-fb37-e063-e6dba90a4e07	ChloraPrep® Frepp® Non-Sterile Solution
54365-400-04	2025-07-29	3b156c62-2885-fb37-e063-e6dba90a4e07	ChloraPrep® 10.5mL Non-Sterile Solution Applicator: Clear, Hi-Lite Orange, Scrub Teal
54365-400-05	2025-07-29	3b156c62-2caa-fb37-e063-e6dba90a4e07	ChloraPrep® 26mL Non-Sterile Solution Applicators, Clear, Hi-Lite Orange, Scrub Teal
54365-400-06	2025-07-29	3b156c62-288b-fb37-e063-e6dba90a4e07	ChloraPrep One-Step 1mL Non-sterile applicator
54365-400-09	2025-07-29	3b156c62-2885-fb37-e063-e6dba90a4e07	ChloraPrep® 10.5mL Non-Sterile Solution Applicator: Clear, Hi-Lite Orange, Scrub Teal
54365-400-11	2025-07-29	3b156c62-2b8f-fb37-e063-e6dba90a4e07	ChloraPrep® Clear 3mL Non-Sterile Applicator
54365-400-12	2025-07-29	3b156c62-2885-fb37-e063-e6dba90a4e07	ChloraPrep® 10.5mL Non-Sterile Solution Applicator: Clear, Hi-Lite Orange, Scrub Teal
54365-400-13	2025-07-29	3b156c62-2caa-fb37-e063-e6dba90a4e07	ChloraPrep® 26mL Non-Sterile Solution Applicators, Clear, Hi-Lite Orange, Scrub Teal
54365-400-14	2025-07-29	3b156c62-2caa-fb37-e063-e6dba90a4e07	ChloraPrep® 26mL Non-Sterile Solution Applicators, Clear, Hi-Lite Orange, Scrub Teal
54365-400-03	2023-01-30	f386c649-a8b8-0266-e053-dadaa90a7c1a	ChloraPrep® 0.67ml Sepp® Applicator
54365-400-08	2023-01-30	f386c649-e363-0266-e053-dadaa90a7c1a	ChloraPrep® 5.25ml Triple Swabstick Applicator

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54365-400-32	ChloraPrep One-Step	25 in 1 CARTON	SOLUTION	25		11
54365-400-32	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		11
54365-400-34	ChloraPrep One-Step	25 in 1 CARTON	SOLUTION	25		11
54365-400-34	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		11
54365-400-30	ChloraPrep One-Step	20 in 1 CARTON	SOLUTION	20		10
54365-400-30	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		10
54365-400-31	ChloraPrep One-Step	60 in 1 CARTON	SOLUTION	60		10
54365-400-31	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		10
54365-400-37	ChloraPrep One-Step	26 mL in 1 APPLICATOR	SOLUTION	26		10
54365-400-37	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		10
54365-400-33	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		8
54365-400-33	ChloraPrep One-Step	25 in 1 CARTON	SOLUTION	25		8
54365-400-35	ChloraPrep One-Step	25 in 1 CARTON	SOLUTION	25		8
54365-400-35	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		8
54365-400-36	ChloraPrep One-Step	25 in 1 CARTON	SOLUTION	25		8
54365-400-36	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		8
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
54365-400-39	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		8
54365-400-39	ChloraPrep One-Step	26 mL in 1 APPLICATOR	SOLUTION	26		8
54365-400-07	ChloraPrep One-Step	1 in 1 POUCH	SOLUTION	1		5
54365-400-07	ChloraPrep One-Step	48 in 1 CARTON	SOLUTION	48		5
54365-400-08	ChloraPrep One-Step	40 in 1 CARTON	SOLUTION	40		5
54365-400-08	ChloraPrep One-Step	3 in 1 POUCH	SOLUTION	3		5
54365-400-11	ACL11CH NERVE BLOCK	3 mL in 1 APPLICATOR	SOLUTION	3 mL	20 mg in 1mL	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	9
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	8
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	7
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A4148 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	5
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A4148 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	5
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	A4148 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	5
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	A4148 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	5
Lidocaine	ACTIVE MOIETY	98PI200987	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	A4148 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	5
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	A4148 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	5
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
LIDOCAINE	ACTIVE MOIETY	98PI200987	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
LIDOCAINE	ACTIVE MOIETY	98PI200987	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	A3873 PERIPHERAL NERVE BLOCK CATHETER INSERTION () KIT [SMITHS MEDICAL ASD, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	A4094 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	4
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
LIDOCAINE	ACTIVE MOIETY	98PI200987	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	A3742 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	3
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	PORTEX NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	2
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	PORTEX NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	2
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	PORTEX NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	2
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	PORTEX NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	2
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PORTEX NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	A3866-22 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PORTEX NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	A3848 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	A3770 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	2
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	1
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A4221-22 NERVE BLOCK 22G QUINCKE () KIT [SMITHS MEDICAL ASD, INC.]	1
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A3865-18 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A4060 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A4077 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A3602 PORTEX NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	A4222 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	A3865-18 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A4221-22 NERVE BLOCK 22G QUINCKE () KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A3602 PORTEX NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A4077 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	NERVE BLOCK (REGIONAL ANESTHESIA KIT) KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A3865-18 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A4060 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	A4222 NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	A4221-22 NERVE BLOCK 22G QUINCKE () KIT [SMITHS MEDICAL ASD, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241124_8529596f-37e4-c44e-e053-2a91aa0ad014.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241124_8541a1ed-2a92-1fab-e053-2a91aa0a29d1.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20241215_85790749-5a95-7f18-e053-2a91aa0a1a02.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20241109_8528a4f5-5ff4-45f3-e053-2991aa0a804c.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20241109_85291b2b-40b9-07fa-e053-2a91aa0a84e4.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241109_85416361-90b5-3efa-e053-2a91aa0af431.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241215_85791e13-4103-19fe-e053-2991aa0a647f.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241215_85794f6b-d1ea-40f9-e053-2991aa0a8823.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241124_8541f219-c060-399a-e053-2991aa0ab05c.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241124_8578da30-a155-2505-e053-2991aa0a2c04.zip
54365-400	CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]	4	Current NDC, Legacy NDC, 4 package rows	20241116_f06e4f9d-6cef-b57a-e053-2a95a90a7337.zip
54365-400	ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]	1	Current NDC, Legacy NDC	20140415_57a2935b-5741-43ce-9833-1de31eb02011.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 · 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	11
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	8529596f-37e4-c44e-e053-2a91aa0ad014	11
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	11
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	8529596f-37e4-c44e-e053-2a91aa0ad014	11
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	11
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	8529596f-37e4-c44e-e053-2a91aa0ad014	11
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	11
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	8529596f-37e4-c44e-e053-2a91aa0ad014	11
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	11
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	8529596f-37e4-c44e-e053-2a91aa0ad014	11
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	8541a1ed-2a92-1fab-e053-2a91aa0a29d1	11
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	8529596f-37e4-c44e-e053-2a91aa0ad014	11
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	85790749-5a95-7f18-e053-2a91aa0a1a02	10
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	85291b2b-40b9-07fa-e053-2a91aa0a84e4	10
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	8528a4f5-5ff4-45f3-e053-2991aa0a804c	10
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	85291b2b-40b9-07fa-e053-2a91aa0a84e4	10
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	8528a4f5-5ff4-45f3-e053-2991aa0a804c	10
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	85790749-5a95-7f18-e053-2a91aa0a1a02	10
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	85291b2b-40b9-07fa-e053-2a91aa0a84e4	10
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	8528a4f5-5ff4-45f3-e053-2991aa0a804c	10
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	85790749-5a95-7f18-e053-2a91aa0a1a02	10
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	85291b2b-40b9-07fa-e053-2a91aa0a84e4	10
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	8528a4f5-5ff4-45f3-e053-2991aa0a804c	10
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	85790749-5a95-7f18-e053-2a91aa0a1a02	10
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	85291b2b-40b9-07fa-e053-2a91aa0a84e4	10
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	85790749-5a95-7f18-e053-2a91aa0a1a02	10
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	8528a4f5-5ff4-45f3-e053-2991aa0a804c	10
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	85291b2b-40b9-07fa-e053-2a91aa0a84e4	10
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	85790749-5a95-7f18-e053-2a91aa0a1a02	10
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	8528a4f5-5ff4-45f3-e053-2991aa0a804c	10
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	8541f219-c060-399a-e053-2991aa0ab05c	8
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	8578da30-a155-2505-e053-2991aa0a2c04	8
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	85794f6b-d1ea-40f9-e053-2991aa0a8823	8
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	85416361-90b5-3efa-e053-2a91aa0af431	8
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	85791e13-4103-19fe-e053-2991aa0a647f	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	85416361-90b5-3efa-e053-2a91aa0af431	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	8541f219-c060-399a-e053-2991aa0ab05c	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	85791e13-4103-19fe-e053-2991aa0a647f	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	85794f6b-d1ea-40f9-e053-2991aa0a8823	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	8578da30-a155-2505-e053-2991aa0a2c04	8
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	85416361-90b5-3efa-e053-2a91aa0af431	8
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	85791e13-4103-19fe-e053-2991aa0a647f	8
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	8541f219-c060-399a-e053-2991aa0ab05c	8
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	85794f6b-d1ea-40f9-e053-2991aa0a8823	8
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	8578da30-a155-2505-e053-2991aa0a2c04	8
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	85791e13-4103-19fe-e053-2991aa0a647f	8
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	85794f6b-d1ea-40f9-e053-2991aa0a8823	8
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	8578da30-a155-2505-e053-2991aa0a2c04	8
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	8541f219-c060-399a-e053-2991aa0ab05c	8
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	85416361-90b5-3efa-e053-2a91aa0af431	8
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	8541f219-c060-399a-e053-2991aa0ab05c	8
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	85416361-90b5-3efa-e053-2a91aa0af431	8
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	8578da30-a155-2505-e053-2991aa0a2c04	8
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	85791e13-4103-19fe-e053-2991aa0a647f	8
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	85794f6b-d1ea-40f9-e053-2991aa0a8823	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	8578da30-a155-2505-e053-2991aa0a2c04	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	8541f219-c060-399a-e053-2991aa0ab05c	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	85416361-90b5-3efa-e053-2a91aa0af431	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	85791e13-4103-19fe-e053-2991aa0a647f	8
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	85794f6b-d1ea-40f9-e053-2991aa0a8823	8
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	f06e4f9d-6cef-b57a-e053-2a95a90a7337	5
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	f06e4f9d-6cef-b57a-e053-2a95a90a7337	5
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	f06e4f9d-6cef-b57a-e053-2a95a90a7337	5
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	f06e4f9d-6cef-b57a-e053-2a95a90a7337	5
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	f06e4f9d-6cef-b57a-e053-2a95a90a7337	5
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	f06e4f9d-6cef-b57a-e053-2a95a90a7337	5
998282	ChloraPrep 2 % / 70 % Topical Solution	PSN	57a2935b-5741-43ce-9833-1de31eb02011	1
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	PSN	57a2935b-5741-43ce-9833-1de31eb02011	1
998282	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [ChloraPrep]	SBD	57a2935b-5741-43ce-9833-1de31eb02011	1
858726	chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	57a2935b-5741-43ce-9833-1de31eb02011	1
998282	ChloraPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical Solution	SY	57a2935b-5741-43ce-9833-1de31eb02011	1
858726	chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical Solution	SY	57a2935b-5741-43ce-9833-1de31eb02011	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54365-400-01	54365040001	25 POUCH in 1 CARTON (54365-400-01) > 1 APPLICATOR in 1 POUCH > 3 mL in 1 APPLICATOR	25 pouch	2000-07-14	0000-00-00	No	No	Current
54365-400-02	54365040002	20 POUCH in 1 CARTON (54365-400-02) > 1 APPLICATOR in 1 POUCH > 1.5 mL in 1 APPLICATOR	20 pouch	2002-04-26	0000-00-00	No	No	Current
54365-400-03	54365040003	200 POUCH in 1 CARTON (54365-400-03) > 1 APPLICATOR in 1 POUCH > .67 mL in 1 APPLICATOR	200 pouch	2002-10-07	0000-00-00	No	No	Current
54365-400-04	54365040004	25 POUCH in 1 CARTON (54365-400-04) > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR	25 pouch	2000-07-14	0000-00-00	No	No	Current
54365-400-05	54365040005	1 APPLICATOR in 1 POUCH (54365-400-05) > 26 mL in 1 APPLICATOR	1 applicator	2002-04-26	0000-00-00	No	No	Current
54365-400-06	54365040006	60 POUCH in 1 CARTON (54365-400-06) > 1 APPLICATOR in 1 POUCH > 1 mL in 1 APPLICATOR	60 pouch	2014-07-23	0000-00-00	No	No	Current
54365-400-07	54365040007	48 POUCH in 1 CARTON (54365-400-07) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR	48 pouch	2005-05-10	0000-00-00	No	No	Current
54365-400-08	54365040008	40 POUCH in 1 CARTON (54365-400-08) / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR	40 pouch	2009-06-10	0000-00-00	No	No	Current
54365-400-09	54365040009	25 POUCH in 1 CARTON (54365-400-09) > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR	25 pouch	2002-04-26	0000-00-00	No	No	Current
54365-400-11	54365040011	25 POUCH in 1 CARTON (54365-400-11) > 1 APPLICATOR in 1 POUCH > 3 mL in 1 APPLICATOR	25 pouch	2006-08-18	0000-00-00	No	No	Current
54365-400-12	54365040012	25 POUCH in 1 CARTON (54365-400-12) > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR	25 pouch	2006-08-18	0000-00-00	No	No	Current
54365-400-13	54365040013	1 APPLICATOR in 1 POUCH (54365-400-13) > 26 mL in 1 APPLICATOR	1 applicator	2006-08-18	0000-00-00	No	No	Current
54365-400-14	54365040014	1 APPLICATOR in 1 POUCH (54365-400-14) > 26 mL in 1 APPLICATOR	1 applicator	2000-07-14	0000-00-00	No	No	Current
54365-400-30	54365040030	20 POUCH in 1 CARTON (54365-400-30) / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR	20 pouch	2019-05-24	0000-00-00	No	No	Current
54365-400-31	54365040031	60 POUCH in 1 CARTON (54365-400-31) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR	60 pouch	2019-05-24	0000-00-00	No	No	Current
54365-400-32	54365040032	25 POUCH in 1 CARTON (54365-400-32) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR	25 pouch	2019-05-24	0000-00-00	No	No	Current
54365-400-33	54365040033	25 POUCH in 1 CARTON (54365-400-33) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR	25 pouch	2019-05-24	0000-00-00	No	No	Current
54365-400-34	54365040034	25 POUCH in 1 CARTON (54365-400-34) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR	25 pouch	2019-05-24	0000-00-00	No	No	Current
54365-400-35	54365040035	25 POUCH in 1 CARTON (54365-400-35) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR	25 pouch	2019-05-24	0000-00-00	No	No	Current
54365-400-36	54365040036	25 POUCH in 1 CARTON (54365-400-36) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR	25 pouch	2019-05-24	0000-00-00	No	No	Current
54365-400-37	54365040037	1 APPLICATOR in 1 POUCH (54365-400-37) / 26 mL in 1 APPLICATOR	1 applicator	2019-05-24	0000-00-00	No	No	Current
54365-400-38	54365040038	1 APPLICATOR in 1 POUCH (54365-400-38) / 26 mL in 1 APPLICATOR	1 applicator	2019-05-24	0000-00-00	No	No	Current
54365-400-39	54365040039	1 APPLICATOR in 1 POUCH (54365-400-39) / 26 mL in 1 APPLICATOR	1 applicator	2019-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BD ChloraPrep™ Clear 1 mL Applicators Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-11-04	HUMAN OTC DRUG LABEL	10
BD ChloraPrep™ FREPP™ Clear 1.5mL Applicators Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-11-03	HUMAN OTC DRUG LABEL	10
BD ChloraPrep™ Hi-Lite Orange™ 3 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Compay	2025-11-03	HUMAN OTC DRUG LABEL	8
BD ChloraPrep™ Clear 3 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-10-30	HUMAN OTC DRUG LABEL	11
BD ChloraPrep™ Scrub Teal 10.5 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-10-29	HUMAN OTC DRUG LABEL	8
BD ChloraPrep™ Hi-Lite Orange™ 10.5 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-10-24	HUMAN OTC DRUG LABEL	8
BD ChloraPrep™ Clear 10.5 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-10-23	HUMAN OTC DRUG LABEL	11
BD ChloraPrep™ Clear 26 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-10-17	HUMAN OTC DRUG LABEL	10
BD ChloraPrep™ Scrub Teal™ 26 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-10-17	HUMAN OTC DRUG LABEL	8
BD ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator with Sterile Solution	CareFusion 213, LLC \| Becton, Dickinson and Company	2025-10-17	HUMAN OTC DRUG LABEL	8
ChloraPrep® Swabsticks	CareFusion 213 LLC \| Becton, Dickinson and Company	2025-07-03	HUMAN OTC DRUG LABEL	5
ChloraPrep® 26mL Non-Sterile Solution Applicators, Clear, Hi-Lite Orange, Scrub Teal	CareFusion 213 LLC \| Becton, Dickinson and Company	2024-12-13	HUMAN OTC DRUG LABEL	20
ChloraPrep® 10.5mL Non-Sterile Solution Applicator: Clear, Hi-Lite Orange, Scrub Teal	CareFusion 213 LLC \| Becton, Dickinson and Company	2024-12-13	HUMAN OTC DRUG LABEL	18
ChloraPrep® Clear 3mL Non-Sterile Applicator	CareFusion 213 LLC \| Becton, Dickinson and Company	2024-12-13	HUMAN OTC DRUG LABEL	17
ChloraPrep® Frepp® Non-Sterile Solution	CareFusion 213 LLC \| Becton, Dickinson and Company	2024-12-13	HUMAN OTC DRUG LABEL	16
ChloraPrep One-Step 1mL Non-sterile applicator	CareFusion 213 LLC \| Becton, Dickinson and Company	2024-12-13	HUMAN OTC DRUG LABEL	11
Betalido-C - Asclemed USA, Inc.	Asclemed USA, Inc.	2024-07-03	HUMAN PRESCRIPTION DRUG LABEL	1