Bactoshield CHG

Product NDC: 11084-815
Requested package NDC: 11084-815-34
11-digit product format: 110840815
Labeler code: 11084
Product ID: 11084-815_1f33e6a6-f412-4e8c-a5be-abf96066ed07
Type: HUMAN OTC DRUG
Nonproprietary name: CHLORHEXIDINE GLUCONATE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Deb USA, Inc.
Application: NDA019125
Marketing category: NDA
Marketing start: 2018-02-01
Marketing end: 2022-01-01
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 40 mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11084-815	11084-815-34	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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N019125-001	DYNA-HEX 4	CHLORHEXIDINE GLUCONATE	4%	SOLUTION / TOPICAL			1984-12-24

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019125-001	DYNA-HEX 4	4%	SOLUTION / TOPICAL	1984-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019125-001	EXIDINE	4%	SOLUTION / TOPICAL	1984-12-24	`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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Meijer Distribution, Inc.	2821b691-0ece-0e35-e054-00144ff8d46c	2026-04-29	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a6403ad-fa5e-2b4a-e054-00144ff8d46c	2026-04-28	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Bactoshield CHG	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	ee0317ff-0988-7621-e053-2a95a90a13fe	2026-04-27	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Cardinal Health	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	4a645652-ae2f-3811-e054-00144ff8d46c	2026-04-27	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a9eda34-d85c-4b66-e054-00144ff88e88	2026-04-27	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
CliniClean	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	f8352f15-b481-ee95-e053-6294a90ac535	2026-04-27	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Solution	CHLORHEXIDINE GLUCONATE 4%	Coloplast Corp	c4e4068b-5e5e-a571-e053-2995a90a98a5	2026-03-27	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	CVS Pharmacy, Inc.	46dc074c-af71-4805-e054-00144ff8d46c	2026-03-03	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	48a814e7-bfe4-5437-e054-00144ff88e88	2026-03-03	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
BETASEPT	ANTISEPTIC SURGICAL SCRUB	Atlantis Consumer Healthcare, Inc.	7e64e7bf-e88f-4056-c9e1-b49a277daa6c	2025-12-24	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
CliniClean	CHLORHEXIDINE GLUCONATE 4%	HR Pharmaceuticals, Inc.	f7959667-6275-802a-e053-6394a90aa7f1	2025-12-16	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Foster and Thrive	CHLORHEXIDINE GLUCONATE 4%	McKesson Corporation	08b60f82-01db-3451-e063-6294a90a2bdc	2025-12-16	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Cardinal Health	7a7aeecf-ce26-5a66-e053-2991aa0ad4a2	2025-12-12	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	AmerisourceBergen Drug Corporation	12ace9af-14ed-2dea-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Topco Associates LLC	a0b7180a-0257-4a64-9d1a-6b6d824fac1c	2025-12-12	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Chain Drug Marketing Association Inc.	12234b17-fd07-6088-e054-00144ff88e88	2025-12-12	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	4aa41583-790c-2446-e054-00144ff8d46c	2025-12-10	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	9f6342f7-faa3-4d23-a860-054d04cb8d42	2025-12-10	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	4a64f7c5-829c-6184-e054-00144ff88e88	2025-12-08	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Foster and Thrive	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	0ce1b132-1f2d-d344-e063-6394a90a57d7	2025-12-08	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	Marketing end	Sample	Exclude flag	Status
11084-815-34	11084081534	473 mL in 1 BOTTLE (11084-815-34)	473 ml	2018-02-01	2021-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bactoshield ® CHG Chlorhexidine Gluconate Solution	Deb USA, Inc. \| Xttrium Laboratories, Inc.	2020-12-08	HUMAN OTC DRUG LABEL	2