Chlorhexidine Gluconate, 0.12% Oral Rinse Solution

Product NDC: 81033-512
11-digit product format: 810330512
Labeler code: 81033
Product ID: 81033-512_2d91fb6c-a2a4-5fcf-e063-6294a90aa15c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorhexidine Gluconate, 0.12% Oral Rinse
Dosage form: SOLUTION
Route: DENTAL
Labeler: Kesin Pharma Corporation
Application: ANDA075561
Marketing category: ANDA
Marketing start: 2023-08-15
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 1.2 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 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
A075561-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT		2000-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075561-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075561-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075561-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075561-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075561-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075561-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075561-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075561-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075561-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075561-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075561-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075561-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075561-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075561-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075561-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075561-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075561-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075561-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075561-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075561-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A075561-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075561-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075561-001	AT	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075561-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075561-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075561-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075561-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075561-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075561-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075561-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075561-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075561-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075561-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075561-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075561-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075561-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075561-001	AT	1	`a50c72e98297…`

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: Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Listing expiration: 2026-12-31

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
326c15fc-90d8-48de-abd0-61e0c4165529	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
81033-512-15	Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15		4
81033-512-50	Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	100 in 1 CARTON	SOLUTION	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-512-15	ML - Milliliter	81033-512	f319a405-4bc6-4f26-824a-16c55631d9e5	1	2024-03-12
81033-512-50	ML - Milliliter	81033-512	771d5677-b180-46be-a9cb-4c22317314c9	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81033-512	CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION (CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE) SOLUTION [KESIN PHARMA CORPORATION]	4	Current NDC, 2 package rows	20250212_326c15fc-90d8-48de-abd0-61e0c4165529.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorhexidine Gluconate Oral Rinse	CHLORHEXIDINE GLUCONATE ORAL RINSE	Atlantic Biologicals Corp.	583986f1-1cce-21c3-e063-6394a90aed1f	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Safco Dental Supply LLC	0d950be9-9d25-202c-e063-6294a90ada7d	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Safco Dental Supply LLC	0d9624f6-2a0b-c30f-e063-6294a90ae717	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
Chlorhexidine Gluconate Oral Rinse	CHLORHEXIDINE GLUCONATE ORAL RINSE	Rising Pharma Holdings, Inc.	b6b45b87-aa53-4d3a-be59-f3d3b0774a7b	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
Chlorhexidine Gluconate, 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE	American Health Packaging	21002357-1780-4a5d-ad54-9936f4a9c031	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
Chlorhexidine Gluconate Oral Rinse	CHLORHEXIDINE GLUCONATE ORAL RINSE	Brisk Pharmaceuticals	2dcc3920-d9ed-bd56-e063-6294a90a0f3e	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE	Kesin Pharma Corporation	326c15fc-90d8-48de-abd0-61e0c4165529	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561 ndc (product): 81033-512
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE	A2A Integrated Pharmaceuticals, LLC	27d81483-e58c-593d-e063-6394a90a0db4	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
Chlorhexidine Gluconate Oral Rinse	CHLORHEXIDINE GLUCONATE ORAL RINSE	NuCare Pharmaceuticals,Inc.	1b1c9dc5-bd3d-d611-e063-6294a90a245d	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION	Bajaj Medical, LLC	d44f4e79-e684-a1ef-e053-2995a90a4620	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075561 application number: ANDA075561

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	326c15fc-90d8-48de-abd0-61e0c4165529	4
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	326c15fc-90d8-48de-abd0-61e0c4165529	4
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	326c15fc-90d8-48de-abd0-61e0c4165529	4
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	326c15fc-90d8-48de-abd0-61e0c4165529	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81033-512-15	81033051215	15 mL in 1 CUP, UNIT-DOSE	15 ml				Historical
81033-512-50	81033051250	100 CUP, UNIT-DOSE in 1 CARTON (81033-512-50) / 15 mL in 1 CUP, UNIT-DOSE (81033-512-15)		2023-08-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	Kesin Pharma Corporation \| Kesin Pharma	2025-02-07	HUMAN PRESCRIPTION DRUG LABEL	4