Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC: 0404-4075
11-digit product format: 004044075
Labeler code: 0404
Product ID: 0404-4075_50b128ed-5377-d42f-e063-6394a90a5f9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form: LIQUID
Route: ORAL
Labeler: Henry Schein, Inc.
Application: ANDA077789
Marketing category: ANDA
Marketing start: 2009-10-01
Marketing end: 2026-09-30
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 1.2 mg/mL
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 1.

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
A077789-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT		2009-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077789-001	AT

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077789-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077789-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077789-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077789-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077789-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077789-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077789-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077789-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077789-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077789-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077789-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077789-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077789-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077789-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077789-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077789-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077789-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077789-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077789-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077789-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077789-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077789-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077789-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077789-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077789-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077789-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077789-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077789-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077789-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077789-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077789-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077789-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077789-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077789-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077789-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077789-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077789-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077789-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077789-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077789-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORHEXIDINE GLUCONATE	1.2 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834127	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
0829509a-1b9b-5d8a-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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
0404-4075-01	Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	473 mL in 1 BOTTLE	LIQUID	473		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2
PEG-40 SORBITAN DIISOSTEARATE	INACTIVE INGREDIENT	JL4CCU7I1G	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-4075	ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [HENRY SCHEIN, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20220915_0829509a-1b9b-5d8a-e054-00144ff8d46c.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 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Major Oral Rinse	0.12% CHLORHEXIDINE GLUCONATE	Cardinal Health 107, LLC	baad6ebb-ba44-4abe-8882-f2391d17d816	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Major Oral Rinse	0.12% CHLORHEXIDINE GLUCONATE	Cardinal Health 107, LLC	772889a1-fc68-4400-9612-6fa51d0b6878	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Henry Schein, Inc.	0829509a-1b9b-5d8a-e054-00144ff8d46c	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789 ndc (product): 0404-4075
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Benco Dental	21b03b2a-44ee-41c0-e054-00144ff8d46c	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3a4cfe-88e0-0a10-e054-00144ff88e88	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3a684f-5f72-347a-e054-00144ff8d46c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Preferred Pharmaceuticals, Inc.	1c3401ef-6a7a-485e-ab7e-52420a36f4e2	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Major Oral Rinse	0.12% CHLORHEXIDINE GLUCONATE	Major Pharmaceuticals	b48e69dc-0913-423f-e053-2a95a90a53df	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Sage Products LLC	3c754532-d9a5-f876-00c4-05a4c9b21efa	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Medline Industries, LP	92eddf00-7e23-4d5b-b5cd-38af99ad9e56	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	REMEDYREPACK INC.	7e3862b9-3786-4cfe-bfad-c992a7038eca	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a2c3c98-4e4e-1c9b-e054-00144ff88e88	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Xttrium Laboratories, Inc.	4a2a6bb8-85b0-6c36-e054-00144ff8d46c	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	ATLANTIC BIOLOGICALS CORP.	ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Atlantic Biologicals Corps.	b445d769-a9e3-f72a-fbab-d485457996d0	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
NUPRO Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3b87bc-d913-6c88-e054-00144ff8d46c	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Xttrium Laboratories, Inc.	4a2bd280-918d-0e26-e054-00144ff88e88	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	NuCare Pharmaceuticals,Inc.	56e5e687-b1b5-6b43-e054-00144ff88e88	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
NUPRO Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"	d9d25abd-c3b4-4713-91c7-538f98e8fb70	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	A-S Medication Solutions	b589dcb9-883a-4f80-8f66-7a6c2051bf2a	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789

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
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	0829509a-1b9b-5d8a-e054-00144ff8d46c	12
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	0829509a-1b9b-5d8a-e054-00144ff8d46c	12
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	0829509a-1b9b-5d8a-e054-00144ff8d46c	12
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	0829509a-1b9b-5d8a-e054-00144ff8d46c	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-4075-01	00404407501	473 mL in 1 BOTTLE (0404-4075-01)	473 ml	2009-10-01	2026-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COMP Henry Schein Acclean Chlorhexidine Gluconate 0.12% Oral Rinse, USP	Henry Schein, Inc. \| Xttrium Laboratories, Inc.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	12