DASH Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC: 69339-138
11-digit product format: 693390138
Labeler code: 69339
Product ID: 69339-138_2e6b1725-1082-4541-9725-2fb49ae15817
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form: LIQUID
Route: ORAL
Labeler: Natco Pharma USA LLC
Application: ANDA074291
Marketing category: ANDA
Marketing start: 2018-04-25
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
A074291-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT		1995-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074291-001	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	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074291-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-28	`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	A074291-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074291-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074291-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074291-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074291-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074291-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074291-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074291-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074291-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074291-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074291-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074291-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074291-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074291-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074291-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074291-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074291-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074291-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074291-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074291-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074291-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074291-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074291-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074291-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074291-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074291-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074291-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074291-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074291-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074291-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074291-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074291-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074291-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074291-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074291-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074291-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074291-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074291-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074291-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074291-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: DASH Chlorhexidine Gluconate 0.12% Oral Rinse
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
12a11cd7-5087-4eb8-aa52-4fad402450f7	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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	SPL version
69339-138-15	DASH Chlorhexidine Gluconate 0.12% Oral Rinse	15 mL in 1 CUP, UNIT-DOSE	LIQUID	15	2
69339-138-17	DASH Chlorhexidine Gluconate 0.12% Oral Rinse	600 mL in 1 DOSE PACK	LIQUID	600	2
69339-138-19	DASH Chlorhexidine Gluconate 0.12% Oral Rinse	1500 mL in 1 DOSE PACK	LIQUID	1500	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69339-138-15	ML - Milliliter	69339-138	dc111d59-4d4a-4b39-88ce-c634959b8e4e	1	2018-05-09
69339-138-17	ML - Milliliter	69339-138	5c0b9d71-0f46-40fa-997f-58d5e2c0d96d	1	2018-05-09
69339-138-19	ML - Milliliter	69339-138	734e9b9c-3125-46fb-8b8f-0fb07a2d2c25	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69339-138	DASH CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [NATCO PHARMA USA LLC]	2	Current NDC, Legacy NDC, 3 package rows	20231031_12a11cd7-5087-4eb8-aa52-4fad402450f7.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DASH Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Cardinal Health 107, LLC	acc9ac8e-6f1c-4fcb-880d-dcc03d411ed3	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074291 application number: ANDA074291
DASH Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Cardinal Health 107, LLC	0253513c-148c-4be7-a6d5-5528f40806fa	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074291 application number: ANDA074291
DASH Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Natco Pharma USA LLC	12a11cd7-5087-4eb8-aa52-4fad402450f7	2023-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074291 application number: ANDA074291 ndc (product): 69339-138
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Lyne Laboratories, Inc.	0348006f-b818-4465-a896-bc0d42294cf4	2019-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074291 application number: ANDA074291

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	0253513c-148c-4be7-a6d5-5528f40806fa	5
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	acc9ac8e-6f1c-4fcb-880d-dcc03d411ed3	5
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	0253513c-148c-4be7-a6d5-5528f40806fa	5
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	acc9ac8e-6f1c-4fcb-880d-dcc03d411ed3	5
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	0253513c-148c-4be7-a6d5-5528f40806fa	5
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	acc9ac8e-6f1c-4fcb-880d-dcc03d411ed3	5
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	0253513c-148c-4be7-a6d5-5528f40806fa	5
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	acc9ac8e-6f1c-4fcb-880d-dcc03d411ed3	5
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	12a11cd7-5087-4eb8-aa52-4fad402450f7	2
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	12a11cd7-5087-4eb8-aa52-4fad402450f7	2
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	12a11cd7-5087-4eb8-aa52-4fad402450f7	2
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	12a11cd7-5087-4eb8-aa52-4fad402450f7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69339-138-15	69339013815	15 mL in 1 CUP, UNIT-DOSE (69339-138-15)	15 ml	2018-04-25	0000-00-00	No	No	Current
69339-138-17	69339013817	600 mL in 1 DOSE PACK (69339-138-17)	600 ml	2018-04-25	0000-00-00	No	No	Current
69339-138-19	69339013819	1500 mL in 1 DOSE PACK (69339-138-19)	1500 ml	2018-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorhexidine Gluconate Oral Rinse USP 0.12%	Cardinal Health 107, LLC	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	5
Chlorhexidine Gluconate Oral Rinse USP 0.12%	Cardinal Health 107, LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
Chlorhexidine Gluconate Oral Rinse USP 0.12%	Natco Pharma USA LLC \| Lyne Laboratories, Inc.	2023-08-04	HUMAN PRESCRIPTION DRUG LABEL	2