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 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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2026-08-01 22:54:32	2026-06	A075561-001	AT	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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

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

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