Application 021524

Type: NDA
Sponsor: PROF DSPLS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREVANTICS SWAB	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	SWAB;TOPICAL	3.15%;70% (1ML)	Yes	Yes
002	PREVANTICS SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	SWAB;TOPICAL	3.15%;70% (1.6ML)	Yes	Yes
003	PREVANTICS MAXI SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	SWAB;TOPICAL	3.15%;70% (5.1ML)	Yes	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
N021524-001	PREVANTICS SWAB	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03
N021524-002	PREVANTICS SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03
N021524-003	PREVANTICS MAXI SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03

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	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`301d65b070ca…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021524-001	M-221	2021-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021524-002	M-221	2021-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021524-003	M-221	2021-02-14	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021524-001	M-221	2021-02-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021524-002	M-221	2021-02-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021524-003	M-221	2021-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021524-001	M-221	2021-02-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021524-002	M-221	2021-02-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021524-003	M-221	2021-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021524-001	M-221	2021-02-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021524-002	M-221	2021-02-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021524-003	M-221	2021-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021524-001	M-221	2021-02-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021524-002	M-221	2021-02-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021524-003	M-221	2021-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021524-001	M-221	2021-02-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021524-002	M-221	2021-02-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021524-003	M-221	2021-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021524-001	M-221	2021-02-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021524-002	M-221	2021-02-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021524-003	M-221	2021-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021524-001	M-221	2021-02-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021524-002	M-221	2021-02-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021524-003	M-221	2021-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021524-001	M-221	2021-02-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021524-002	M-221	2021-02-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021524-003	M-221	2021-02-14	`ea99ee380514…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prevantics Swabstick	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	Professional Disposables International, Inc.	9841200b-d4c6-b40c-e053-2995a90a5596	2025-02-10	Warnings	Exact identifier application applno (NDA): 021524 application number: NDA021524 ndc (product): 10819-4077
Prevantics Swab	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	Professional Disposables International, Inc.	ff999b50-0b6b-404e-b4f1-c6694fe47a9b	2023-10-13	Warnings	Exact identifier application applno (NDA): 021524 application number: NDA021524 ndc (product): 10819-1080
Prevantics Swab	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	Professional Disposables International, Inc.	db61e7fd-c421-4e3c-bc88-0343230273de	2023-10-13	Warnings	Exact identifier application applno (NDA): 021524 application number: NDA021524 ndc (product): 10819-1080
Prevantics Maxi Swabstick	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	Professional Disposables International, Inc.	93ca3c07-40b4-3a91-e053-2995a90a0afd	2023-06-30	Warnings	Exact identifier application applno (NDA): 021524 application number: NDA021524 ndc (product): 10819-4076

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10819-1080	Prevantics Swab	Chlorhexidine Gluconate and Isopropyl Alcohol	Professional Disposables International, Inc.	NDA	Current
10819-1080	Prevantics Swab	Chlorhexidine Gluconate and Isopropyl Alcohol	Professional Disposables International, Inc.	NDA	Current
10819-1080	Prevantics Swab	Chlorhexidine Gluconate and Isopropyl Alcohol	Professional Disposables International, Inc.	NDA	Current
10819-1080	Prevantics Swab	Chlorhexidine Gluconate and Isopropyl Alcohol	Professional Disposables International, Inc.	NDA	Current
10819-1080	Prevantics Swab	Chlorhexidine Gluconate and Isopropyl Alcohol	Professional Disposables International, Inc.	NDA	Current
10819-1080	Prevantics Swab	Chlorhexidine Gluconate and Isopropyl Alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4075	Prevantics swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4076	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4076	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4076	Prevantics Maxi Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4077	Prevantics Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current
10819-4077	Prevantics Swabstick	chlorhexidine gluconate and isopropyl alcohol	Professional Disposables International, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69811	SUPPL	2022-01-05
68687	SUPPL	2021-09-21
57308	SUPPL	2019-01-22
57293	SUPPL	2019-01-22
52641	SUPPL	2018-02-14
49810	SUPPL	2017-09-20
49726	SUPPL	2017-09-13
37150	SUPPL	2014-07-29
5636	SUPPL	2014-07-28
15683	SUPPL	2014-03-26
5635	SUPPL	2014-03-26
5634	SUPPL	2012-05-18
5633	SUPPL	2012-03-05
37149	SUPPL	2007-10-22
28022	SUPPL	2007-10-22
21713	ORIG	2007-07-18
15682	SUPPL	2007-03-23
5632	SUPPL	2007-03-23
15681	ORIG	2005-06-07
5631	ORIG	2005-06-07