CliniClean

Product NDC: 69464-901
11-digit product format: 694640901
Labeler code: 69464
Product ID: 69464-901_461403d2-2038-2ff8-e063-6394a90a7d59
Type: HUMAN OTC DRUG
Nonproprietary name: CHLORHEXIDINE GLUCONATE 4%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: HR Pharmaceuticals, Inc.
Application: NDA019125
Marketing category: NDA
Marketing start: 2023-03-23
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

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69464-901		D	Discontinued by firm	2026-10-05
excluded product	product	69464-901		D	Discontinued by firm	2026-10-05
excluded package	package	69464-901	69464-901-05	D	Discontinued by firm	2026-10-05
excluded package	package	69464-901	69464-901-08	D	Discontinued by firm	2026-10-05
excluded package	package	69464-901	69464-901-04	D	Discontinued by firm	2026-10-05
excluded package	package	69464-901	69464-901-15	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019125-001	DYNA-HEX 4	4%	SOLUTION / TOPICAL	1984-12-24	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: CliniClean
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
211365	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
f7959667-6275-802a-e053-6394a90aa7f1	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
69464-901-08	CliniClean	237 mL in 1 BOTTLE	SOLUTION	237	3
69464-901-16	CliniClean	473 mL in 1 BOTTLE	SOLUTION	473	3
69464-901-32	CliniClean	946 mL in 1 BOTTLE	SOLUTION	946	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69464-901	CLINICLEAN (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [HR PHARMACEUTICALS, INC.]	3	Current NDC	20231220_f6f66215-afa6-2ca3-e053-6394a90a0aa4.zip
69464-901	CLINICLEAN (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [HR PHARMACEUTICALS, INC.]	2	Current NDC, 3 package rows	20231220_f7959667-6275-802a-e053-6394a90aa7f1.zip
69464-901	CLINICLEAN (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [HR PHARMACEUTICALS, INC.]	1	Current NDC	20230328_f7984baf-99e8-94a2-e053-6294a90ac22d.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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactoshield CHG	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	ee13e824-9202-c504-e053-2a95a90a7a7f	2025-12-08	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	4a68456e-4183-5371-e054-00144ff88e88	2025-11-21	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Xttrium Laboratories, Inc.	4ab2cfc2-7adb-20c4-e054-00144ff8d46c	2025-04-30	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
BETASEPT	ANTISEPTIC SURGICAL SCRUB	Xttrium Laboratories, Inc.	4a6451d7-b347-37ac-e054-00144ff8d46c	2025-04-30	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6e5e678f-3832-d201-e053-2a91aa0a5ea8	2025-04-30	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	McKesson Medical-Surgical	626d7aa9-b8da-4254-9c57-9007ed4290d4	2025-01-16	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Walgreen Co.	12aff7f5-c41e-5760-e054-00144ff8d46c	2024-11-08	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Rite Aid	bff185e2-b66f-9fa2-e053-2a95a90ab738	2023-11-09	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
DYNA-HEX 4	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	245c41e6-a0f6-0825-e054-00144ff8d46c	2023-11-09	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Rite Aid Corporation	12c4ced7-2ec7-3b07-e054-00144ff88e88	2023-11-06	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	4c133721-ad9a-4807-8ad5-c3efdff1ec52	2022-11-28	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	Rite Aid	be5df410-f893-a68f-e053-2995a90a1858	2021-03-25	Warnings	Exact identifier application applno (NDA): 019125 application number: NDA019125
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6e62eb50-ebaa-361e-e053-2991aa0aba6f	2018-06-11	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	f7959667-6275-802a-e053-6394a90aa7f1	3
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	f7959667-6275-802a-e053-6394a90aa7f1	3
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	f7959667-6275-802a-e053-6394a90aa7f1	3
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	f7959667-6275-802a-e053-6394a90aa7f1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69464-901-08	69464090108	237 mL in 1 BOTTLE	237 ml				Historical
69464-901-16	69464090116	473 mL in 1 BOTTLE (69464-901-16)	473 ml	2023-03-23	No	No	Current
69464-901-32	69464090132	946 mL in 1 BOTTLE (69464-901-32)	946 ml	2023-03-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
4% HR Pharma 16oz, & 32oz COMP 8oz	HR Pharmaceuticals, Inc. \| Xttrium Laboratories, Inc.	2025-12-16	HUMAN OTC DRUG LABEL	3
4% HR Pharma 15 mL Packets, 15mL Carton, COMP 4oz	HR Pharmaceuticals, Inc. \| Xttrium Laboratories, Inc. \| Xttrium Laboratories, Inc	2025-12-16	HUMAN OTC DRUG LABEL	2
4% HR Pharma 4-oz Foamer	HR Pharmaceuticals, Inc. \| Xttrium Laboratories, Inc. \| Xttrium Laboratories, Inc	2023-12-18	HUMAN OTC DRUG LABEL	3