CHLORAPREP

Product NDC: 51662-1675
Requested package NDC: 51662-1675-1
11-digit product format: 516621675
Labeler code: 51662
Product ID: 51662-1675_44fe08e0-4e9d-8bd6-e063-6394a90a0e2b
Type: HUMAN OTC DRUG
Nonproprietary name: CHLORAPREP
Dosage form: SOLUTION
Route: TOPICAL
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA021555
Marketing category: NDA
Marketing start: 2024-05-13
Substance: ISOPROPYL ALCOHOL; CHLORHEXIDINE GLUCONATE
Active strength: .7; 20 mL/mL; mg/mL
Pharmacologic classes: Decreased Cell Wall Integrity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 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	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	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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CHLORAPREP
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOPROPYL ALCOHOL	.7 mL/mL
CHLORHEXIDINE GLUCONATE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ND2M416302	Internal UNII lookup
MOR84MUD8E	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
44fe08e0-4e9c-8bd6-e063-6394a90a0e2b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1675-1	CHLORAPREP	1.75 mL in 1 APPLICATOR	SOLUTION	1.75		1
51662-1675-1	CHLORAPREP	1 in 1 POUCH	SOLUTION	1		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

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 ndc (package): 51662-1675-1 ndc (product): 51662-1675 ndc11 (package): 51662167501
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51662-1675-1	51662167501	1 APPLICATOR in 1 POUCH (51662-1675-1) / 1.75 mL in 1 APPLICATOR	1 applicator	2024-05-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHLORAPREP - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2025-12-02	HUMAN OTC DRUG LABEL	1