Application 019422

Type: NDA
Sponsor: XTTRIUM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXIDINE	CHLORHEXIDINE GLUCONATE	SOLUTION;TOPICAL	2%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019422-001	DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	2%	SOLUTION / TOPICAL		RLD, RS	1985-12-17

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 2 · 42 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	N019422-001	DYNA-HEX 2	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019422-001	EXIDINE	2%	SOLUTION / TOPICAL	RLD, RS	1985-12-17	`e64feba35796…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63	2026-04-27	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 0116-1021
Bactoshield CHG	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	edfd2be7-b14b-7bd1-e053-2a95a90aa668	2025-12-08	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 0116-0038
foaming hand wash	CHLORHEXIDINE GLUCONATE	Medline Industries, LP	9b926809-65e9-4e5b-e053-2995a90add10	2025-09-08	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 53329-994
Provon Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	46dd136c-d569-0450-e054-00144ff8d46c	2025-04-30	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 0116-8500
DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6e5f9616-ddf5-19c4-e053-2991aa0a372a	2025-04-30	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 0116-1021
Dyna-Hex 2	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	0c808ebd-1bf7-175d-e063-6294a90ae7df	2025-04-30	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 0116-1022
Purell Antimicrobial Foam	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	6c7e63c2-428b-2be2-e053-2a91aa0a6af3	2024-12-21	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 21749-225
Provon Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2%	Gojo Industries, Inc.	365c3ac6-6c1f-594b-e054-00144ff88e88	2022-12-20	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 21749-850
Bactoshield CHG Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	46084e90-6ffa-4e1a-a8ff-1c1b1484fe88	2022-11-28	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 11084-038
Dyna-Hex 2	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	36e6abcb-d792-3ef4-e054-00144ff8d46c	2020-10-13	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 0116-1022
Provon Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2%	Gojo Industries, Inc.	36803a5b-3075-5d5b-e054-00144ff8d46c	2019-06-19	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 21749-850
Antimicrobial Skin Cleanser	CHLORHEXIDINE GLUCONATE 2% SOLUTION	Gojo Industries, Inc.	759beac3-6fc8-40c6-e053-2a91aa0aab57	2019-06-18	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 21749-106
Purell Antimicrobial Foam	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	6e0f3d2f-7834-68a0-e053-2991aa0ab453	2019-06-18	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 21749-225
Antimicrobial Foam Handwash	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	743021cd-38c3-3825-e053-2a91aa0aa7f2	2018-08-24	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 21749-416
Antiseptic Foam Handwash	CHLORHEXIDINE GLUCONATE 2% SOLUTION	GOJO Industries, Inc.	74317b4d-3fbf-6fd5-e053-2a91aa0ab90f	2018-08-24	Warnings	Exact identifier application applno (NDA): 019422 application number: NDA019422 ndc (product): 21749-461

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0116-0038	Bactoshield CHG	Chlorhexidine Gluconate 2%	Xttrium Laboratories, Inc.	NDA	Current
0116-0113	Cardinal Health Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	NDA	Current
0116-0506	BD E-Z Scrub	chlorhexidine gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-0506	BD E-Z Scrub	chlorhexidine gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-0722	Scrub Care	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-0722	Scrub Care	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-0722	Scrub Care	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-1021	DYNA-HEX	Chlorhexidine gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-1021	DYNA-HEX	Chlorhexidine Gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-1021	DYNA-HEX	Chlorhexidine gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-1021	DYNA-HEX	Chlorhexidine Gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-1021	DYNA-HEX	Chlorhexidine gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-1021	DYNA-HEX	Chlorhexidine Gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-1022	Dyna-Hex 2	Chlorhexidine Gluconate 2%	Xttrium Laboratories, Inc.	NDA	Current
0116-1022	Dyna-Hex 2	Chlorhexidine Gluconate 2%	Xttrium Laboratories, Inc.	NDA	Current
0116-1022	Dyna-Hex 2	Chlorhexidine Gluconate 2%	Xttrium Laboratories, Inc.	NDA	Current
0116-1130	Cardinal Health Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	NDA	Current
0116-1130	Cardinal Health Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 2%	Xttrium Laboratories, Inc.	NDA	Current
0116-1322	Bactoshield CHG	Chlorhexidine Gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-1919	Aplicare Chlorhexidine Gluconate 2% Solution	Chlorhexidine Gluconate	Xttrium Laboratories, Inc.	NDA	Current
0116-2800	Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-2800	Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-2800	Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-2992	Scrub Care	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-2992	Scrub Care	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-4242	Scrub Care	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-4242	Scrub Care	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	NDA	Current
0116-8500	Provon Antimicrobial Foam Handwash	Chlorhexidine Gluconate 2%	Xttrium Laboratories, Inc.	NDA	Current
11084-038	Bactoshield CHG	Chlorhexidine Gluconate	SC Johnson Professional USA, Inc.	NDA	Current
11084-814	Bactoshield CHG	Chlorhexidine Gluconate	Deb USA, Inc.	NDA	Current
11084-814	Bactoshield CHG	Chlorhexidine Gluconate	Deb USA, Inc.	NDA	Current
17271-506	BD E-Z Scrub	chlorhexidine gluconate	Becton Dickinson and Company	NDA	Current
17271-506	BD E-Z Scrub	chlorhexidine gluconate	Becton Dickinson and Company	NDA	Current
21749-106	Antimicrobial Skin Cleanser	Chlorhexidine Gluconate 2% Solution	Gojo Industries, Inc.	NDA	Current
21749-106	Antimicrobial Skin Cleanser	Chlorhexidine Gluconate 2% Solution	Gojo Industries, Inc.	NDA	Current
21749-225	Purell Antimicrobial Foam	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-225	Purell Antimicrobial Foam	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-225	Purell Antimicrobial Foam	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-225	Purell Antimicrobial Foam	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-225	Purell Antimicrobial Foam	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-226	Purell CS Foam Handwash 2% CHG	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-416	Antimicrobial Foam Handwash	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-461	Antiseptic Foam Handwash	Chlorhexidine Gluconate 2% Solution	GOJO Industries, Inc.	NDA	Current
21749-850	Provon Antimicrobial Foam Handwash	Chlorhexidine Gluconate 2%	Gojo Industries, Inc.	NDA	Current
21749-850	Provon Antimicrobial Foam Handwash	Chlorhexidine Gluconate 2%	Gojo Industries, Inc.	NDA	Current
21749-850	Provon Antimicrobial Foam Handwash	Chlorhexidine Gluconate 2%	Gojo Industries, Inc.	NDA	Current
21749-850	Provon Antimicrobial Foam Handwash	Chlorhexidine Gluconate 2%	Gojo Industries, Inc.	NDA	Current
46122-659	Antiseptic Skin Cleanser	2% Chlorhexidine Gluconate Solution	AmerisourceBergen Drug Corporation	NDA	Current
52380-1274	Aplicare Antiseptic Chlorhexidine Gluconate	Chlorhexidine Gluconate	Aplicare, Inc.	NDA	Current
52380-1919	Aplicare Chlorhexidine Gluconate 2% Solution	Chlorhexidine Gluconate	Aplicare, Inc.	NDA	Current
52380-1919	Aplicare Chlorhexidine Gluconate 2% Solution	Chlorhexidine Gluconate	Aplicare Products, LLC.	NDA	Current
53329-994	foaming hand wash	chlorhexidine gluconate	Medline Industries, Inc.	NDA	Current
53329-994	foaming hand wash	chlorhexidine gluconate	Medline Industries, lP	NDA	Current
53329-994	foaming hand wash	chlorhexidine gluconate	Medline Industries, LP	NDA	Current
53329-994	foaming hand wash	chlorhexidine gluconate	Medline Industries, LP	NDA	Current
59779-722	Scrub Care	CHLORHEXIDINE GLUCONATE	CVS Pharmacy, Inc.	NDA	Current
59779-722	Scrub Care	CHLORHEXIDINE GLUCONATE	CVS Pharmacy, Inc.	NDA	Current
59779-722	Scrub Care	CHLORHEXIDINE GLUCONATE	CVS Pharmacy, Inc.	NDA	Current
59779-722	Scrub Care	CHLORHEXIDINE GLUCONATE	CVS Pharmacy, Inc.	NDA	Current
63517-113	Cardinal Health Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 2%	Cardinal Health	NDA	Current
63517-113	Cardinal Health Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 2%	Cardinal Health	NDA	Current
63868-280	Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Quality Choice	NDA	Current
63868-280	Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Quality Choice	NDA	Current
63868-280	Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Quality Choice	NDA	Current
67659-901	Dyna-Hex	CHLORHEXIDINE GLUCONATE	Team Technologies, Inc	NDA	Current
67659-901	Dyna-Hex	CHLORHEXIDINE GLUCONATE	Team Technologies, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84911	SUPPL	2026-02-05
84910	SUPPL	2026-02-05
57510	SUPPL	2019-02-13
57457	SUPPL	2019-02-06
49785	SUPPL	2017-09-19
33740	SUPPL	2014-01-14
1322	SUPPL	2012-12-18
1321	SUPPL	2009-02-27
1320	SUPPL	2009-02-27
40910	SUPPL	2007-07-09
1319	SUPPL	2004-12-30
17389	SUPPL	2003-12-23