Application 019258

Type: NDA
Sponsor: ECOLAB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIDA-STAT	CHLORHEXIDINE GLUCONATE	SOLUTION;TOPICAL	2%	No	No
002	CHG SCRUB	CHLORHEXIDINE GLUCONATE	SOLUTION;TOPICAL	4%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019258-001	CIDA-STAT	CHLORHEXIDINE GLUCONATE	2%	SOLUTION / TOPICAL			1986-07-22
N019258-002	CHG SCRUB	CHLORHEXIDINE GLUCONATE	4%	SOLUTION / TOPICAL			1986-07-22

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019258-001	CIDA-STAT	2%	SOLUTION / TOPICAL	1986-07-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019258-002	CHG SCRUB	4%	SOLUTION / TOPICAL	1986-07-22	`782e0a99824c…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%	CHLORHEXIDINE GLUCONATE	Henry Schein, Inc.	4b0b50ef-78e1-5595-e063-6294a90aa84d	2026-02-17	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%	CHLORHEXIDINE GLUCONATE	Henry Schein, Inc.	4b0c6bcd-2242-f734-e063-6294a90a8fbf	2026-02-17	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%	CHLORHEXIDINE GLUCONATE	Henry Schein, Inc.	4b0d7b42-5757-6248-e063-6394a90a94c5	2026-02-17	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Rising Pharma Holdings, Inc.	d53a01eb-7213-4f19-b74f-acbf0fd54418	2026-02-10	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	20e79dbb-8f33-469d-a7ca-29afde16a8ee	2026-01-02	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 47593-463
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	4b4b02c7-b44a-483e-8e6b-79d994037490	2025-12-31	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 47593-467
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	5d49522f-63e5-4297-adf5-b5f3bd419d47	2025-07-09	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 11084-128
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	da5d244d-e9c1-45a5-8f4e-ed1d3b9d02a9	2025-07-09	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 11084-126
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	b4444803-034c-4e22-9a21-9e07207df36e	2024-10-03	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 47593-464
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	c126e473-e9ae-4749-a5e9-07191ec8c1fb	2024-10-03	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 47593-468
Halyard Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Owens & Minor, Inc.	240c5de0-dc33-1bb8-e063-6394a90ac701	2024-09-04	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258
Halyard Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Owens & Minor, Inc.	262e1975-bf99-cd3f-e063-6394a90a0a5b	2024-09-04	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	1f1eebef-9aac-b847-e063-6394a90a26cc	2024-08-07	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-125
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e3c8e79-230e-4dd3-e054-00144ff88e88	2024-05-02	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-128
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e398787-7003-6502-e054-00144ff88e88	2023-11-03	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-127
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e3d67c6-180c-1d9c-e054-00144ff8d46c	2023-11-03	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-125
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	42b0a0a9-6c5e-45c7-e054-00144ff88e88	2023-11-03	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-124
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e3bcbd1-de23-4d86-e054-00144ff8d46c	2023-11-03	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-124
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	43401362-8e54-1f5d-e054-00144ff8d46c	2023-11-03	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-125
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	9dc6d487-b51b-985b-e053-2995a90a8823	2022-12-26	Warnings	Exact identifier application applno (NDA): 019258 application number: NDA019258 ndc (product): 42939-127

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11084-126	Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	NDA	Current
11084-126	Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	NDA	Current
11084-128	Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	NDA	Current
11084-128	Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-124	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-125	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-127	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-127	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-127	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-127	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-127	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-127	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-128	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-128	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-128	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-128	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-128	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
42939-128	Scrub, Scrub-Stat, Foam Safe, Micro-Guard	Chlorhexidine gluconate	AVA, Inc.	NDA	Current
47593-265	Endure 400 Scrub-Stat 4	Chlorhexidine gluconate	Ecolab Inc.	NDA	Current
47593-303	Endure 420 Cida-Stat	Chlorhexidine gluconate	Ecolab Inc.	NDA	Current
47593-463	Scrub-Stat	Chlorhexidine gluconate	Ecolab Inc.	NDA	Current
47593-464	Scrub-Stat	Chlorhexidine gluconate	Ecolab Inc.	NDA	Current
47593-467	Scrub-Stat	Chlorhexidine gluconate	Ecolab Inc.	NDA	Current
47593-468	Scrub-Stat	Chlorhexidine gluconate	Ecolab Inc.	NDA	Current
61037-421	Scrub, Scrub-Stat	Chlorhexidine gluconate	Bajaj Medical, LLC	NDA	Current
81657-002	Dr. Dean	Chlorhexidine Gluconate Liquid Solution 2%	USA Medical Supply LLC	NDA	Current
81657-003	Dr. Dean	Chlorhexidine Gluconate Liquid Solution 4%	USA Medical Supply LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
51077	SUPPL	2018-01-17
51030	SUPPL	2018-01-11
33712	SUPPL	2016-01-15
17339	SUPPL	2016-01-15
17338	SUPPL	2015-08-10
17337	SUPPL	2012-05-21
1265	SUPPL	2010-04-28
1264	SUPPL	2006-04-07
1263	SUPPL	2005-02-17