Bactoshield CHG

Product NDC: 0116-0039
11-digit product format: 001160039
Labeler code: 0116
Product ID: 0116-0039_45771aee-e7f8-d9a5-e063-6294a90aa15c
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorhexidine Gluconate 4%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Xttrium Laboratories, Inc.
Application: NDA019125
Marketing category: NDA
Marketing start: 2022-11-22
Marketing end: 2027-11-30
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 2 mg/100mL
Pharmacologic classes: Decreased Cell Wall Integrity [PE]
NDC exclude flag: No
Current FDA listing: 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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bactoshield CHG

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORHEXIDINE GLUCONATE	2 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
ee13e824-9202-c504-e053-2a95a90a7a7f	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
0116-0039-03	Bactoshield CHG	118 mL in 1 BOTTLE	SOLUTION	118		4
0116-0039-24	Bactoshield CHG	946 mL in 1 BOTTLE	SOLUTION	946		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0116-0039	BACTOSHIELD CHG (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250503_ee13e824-9202-c504-e053-2a95a90a7a7f.zip
0116-0039	BACTOSHIELD CHG (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250503_ee0317ff-0988-7621-e053-2a95a90a13fe.zip

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 ndc (product): 0116-0039
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
0116-0039-03	00116003903	118 mL in 1 BOTTLE (0116-0039-03)	118 ml	2022-11-21	2027-12-31	No	No	Current
0116-0039-24	00116003924	946 mL in 1 BOTTLE (0116-0039-24)	946 ml	2022-11-22	2027-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XTT COMP SCJ 4oz 4% CHG Bactoshield	Xttrium Laboratories, Inc.	2026-04-27	HUMAN OTC DRUG LABEL	4
XTT COMP SCJ 32oz 4% CHG Bactoshield	Xttrium Laboratories, Inc.	2025-12-08	HUMAN OTC DRUG LABEL	4