DYNA-HEX 4

Product NDC: 0116-1060
11-digit product format: 001161060
Labeler code: 0116
Product ID: 0116-1060_09bfde37-90b8-1319-e063-6294a90a8ffc
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorhexidine Gluconate
Dosage form: LIQUID
Route: TOPICAL
Labeler: Xttrium Laboratories, Inc.
Application: NDA019125
Marketing category: NDA
Marketing start: 2016-01-01
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 4 g/100mL
Pharmacologic classes: Decreased Cell Wall Integrity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: DYNA-HEX 4
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORHEXIDINE GLUCONATE	4 g/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
211365	Internal RxNorm lookup
834162	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
245c41e6-a0f6-0825-e054-00144ff8d46c	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	SPL version
0116-1060-18	DYNA-HEX 4	535 mL in 1 BOTTLE, PLASTIC	LIQUID	535	4
0116-1060-32	Dyna-Hex 4	946 mL in 1 BOTTLE, PLASTIC	LIQUID	946	4
0116-1060-33	Dyna-Hex 4	946 mL in 1 BOTTLE, PLASTIC	LIQUID	946	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0116-1060-18	ML - Milliliter	0116-1060	e64401a6-a26b-4236-a170-a4909ee6a1bf	1	2018-10-11
0116-1060-32	ML - Milliliter	0116-1060	29c0bba8-fb2a-4ed9-a077-ba532ec67851	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0116-1060	DYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20231110_245c41e6-a0f6-0825-e054-00144ff8d46c.zip
0116-1060	DYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250503_0a32c299-f7ca-d15c-e063-6294a90af2c1.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 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dyna-Hex 4	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	0a32c299-f7ca-d15c-e063-6294a90af2c1	2026-04-30	Warnings	Exact identifier ndc (product): 0116-1060
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	0a32c299-f7ca-d15c-e063-6294a90af2c1	4
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	245c41e6-a0f6-0825-e054-00144ff8d46c	4
834162	DYNA-HEX 4 4 % Medicated Liquid Soap	PSN	0a32c299-f7ca-d15c-e063-6294a90af2c1	4
834162	DYNA-HEX 4 4 % Medicated Liquid Soap	PSN	245c41e6-a0f6-0825-e054-00144ff8d46c	4
834162	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Dyna-Hex]	SBD	0a32c299-f7ca-d15c-e063-6294a90af2c1	4
834162	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Dyna-Hex]	SBD	245c41e6-a0f6-0825-e054-00144ff8d46c	4
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	0a32c299-f7ca-d15c-e063-6294a90af2c1	4
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	245c41e6-a0f6-0825-e054-00144ff8d46c	4
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	0a32c299-f7ca-d15c-e063-6294a90af2c1	4
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	245c41e6-a0f6-0825-e054-00144ff8d46c	4
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	0a32c299-f7ca-d15c-e063-6294a90af2c1	4
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	245c41e6-a0f6-0825-e054-00144ff8d46c	4
834162	Dyna-Hex 4 % Medicated Liquid Soap	SY	0a32c299-f7ca-d15c-e063-6294a90af2c1	4
834162	Dyna-Hex 4 % Medicated Liquid Soap	SY	245c41e6-a0f6-0825-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0116-1060-18	00116106018	535 mL in 1 BOTTLE, PLASTIC (0116-1060-18)	535 ml	2016-01-01	0000-00-00	No	No	Current
0116-1060-32	00116106032	946 mL in 1 BOTTLE, PLASTIC (0116-1060-32)	946 ml	2023-11-15	2027-10-31	No	No	Historical
0116-1060-33	00116106033	946 mL in 1 BOTTLE, PLASTIC (0116-1060-33)	946 ml	2023-12-14		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dyna-Hex 32oz Round & Sqaure Bottle XTT COMP 32 oz Round	Xttrium Laboratories, Inc.	2026-04-30	HUMAN OTC DRUG LABEL	4
4% Dyna-Hex, 18-oz	Xttrium Laboratories, Inc.	2023-11-09	HUMAN OTC DRUG LABEL	4