Dyna-Hex 2

Product NDC: 0116-1022
11-digit product format: 001161022
Labeler code: 0116
Product ID: 0116-1022_3400ba9f-d027-b3f7-e063-6394a90ac53a
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorhexidine Gluconate 2%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Xttrium Laboratories, Inc.
Application: NDA019422
Marketing category: NDA
Marketing start: 2023-12-14
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 20 mg/mL
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dyna-Hex 2
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORHEXIDINE GLUCONATE	20 mg/mL

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
834160	Internal RxNorm lookup
1245230	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
0c808ebd-1bf7-175d-e063-6294a90ae7df	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
0116-1022-18	Dyna-Hex 2	535 mL in 1 BOTTLE	SOLUTION	535		3
0116-1022-32	Dyna-Hex 2	946 mL in 1 BOTTLE	SOLUTION	946		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0116-1022	DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20201014_36e6abcb-d792-3ef4-e054-00144ff8d46c.zip
0116-1022	DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20250503_0c808ebd-1bf7-175d-e063-6294a90ae7df.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 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
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
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
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
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
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
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
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
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
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
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
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
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

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
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	PSN	36e6abcb-d792-3ef4-e054-00144ff8d46c	3
834160	DYNA-HEX 2 2 % Medicated Liquid Soap	PSN	36e6abcb-d792-3ef4-e054-00144ff8d46c	3
834160	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]	SBD	36e6abcb-d792-3ef4-e054-00144ff8d46c	3
1245230	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap	SCD	36e6abcb-d792-3ef4-e054-00144ff8d46c	3
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	SY	36e6abcb-d792-3ef4-e054-00144ff8d46c	3
834160	Dyna-Hex 2 % Medicated Liquid Soap	SY	36e6abcb-d792-3ef4-e054-00144ff8d46c	3
834160	Dyna-Hex 20 MG/ML Medicated Liquid Soap	SY	36e6abcb-d792-3ef4-e054-00144ff8d46c	3
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	PSN	0c808ebd-1bf7-175d-e063-6294a90ae7df	2
834160	DYNA-HEX 2 2 % Medicated Liquid Soap	PSN	0c808ebd-1bf7-175d-e063-6294a90ae7df	2
834160	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]	SBD	0c808ebd-1bf7-175d-e063-6294a90ae7df	2
1245230	chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap	SCD	0c808ebd-1bf7-175d-e063-6294a90ae7df	2
1245230	chlorhexidine gluconate 2 % Medicated Liquid Soap	SY	0c808ebd-1bf7-175d-e063-6294a90ae7df	2
834160	Dyna-Hex 2 % Medicated Liquid Soap	SY	0c808ebd-1bf7-175d-e063-6294a90ae7df	2
834160	Dyna-Hex 20 MG/ML Medicated Liquid Soap	SY	0c808ebd-1bf7-175d-e063-6294a90ae7df	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0116-1022-18	00116102218	535 mL in 1 BOTTLE (0116-1022-18)	535 ml	2016-01-29	0000-00-00	No	No	Current
0116-1022-32	00116102232	946 mL in 1 BOTTLE (0116-1022-32)	946 ml	2023-12-14		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dyna-Hex 2% Square	Xttrium Laboratories, Inc.	2025-04-30	HUMAN OTC DRUG LABEL	2
2% Dyna-Hex, 18-oz	Xttrium Laboratories, Inc.	2020-10-13	HUMAN OTC DRUG LABEL	3