CHLORHEXIDINE GLUCONATE

Product NDC: 68788-8173
11-digit product format: 687888173
Labeler code: 68788
Product ID: 68788-8173_4680dfee-0622-4ae8-9a19-8155d3f0a8de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORHEXIDINE GLUCONATE
Dosage form: RINSE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA074522
Marketing category: ANDA
Marketing start: 2022-04-27
Marketing end: 0000-00-00
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 1 mg/mL
Pharmacologic classes: Decreased Cell Wall Integrity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-8173		D	Discontinued by firm		2026-08-17
excluded package	package	68788-8173	68788-8173-4	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074522-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT		1995-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074522-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074522-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074522-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074522-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074522-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074522-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074522-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074522-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074522-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074522-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074522-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074522-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074522-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074522-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074522-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074522-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074522-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074522-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074522-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074522-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074522-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074522-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074522-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074522-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074522-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074522-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074522-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074522-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074522-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074522-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074522-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074522-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074522-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074522-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074522-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074522-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074522-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074522-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074522-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074522-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074522-001	AT	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8173-4	ML - Milliliter	68788-8173	1fb7db05-f8e8-4d07-afe0-bd3879ecc174	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8173	CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20250302_4680dfee-0622-4ae8-9a19-8155d3f0a8de.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	PAI Holdings, LLC dba PAI Pharma	d3c2d8a7-bad5-410f-af83-e78a45e4b93f	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074522 application number: ANDA074522

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8173-4	68788817304	473 mL in 1 BOTTLE (68788-8173-4)	473 ml	2022-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorhexidine Gluconate Oral Rinse USP, 0.12%	Preferred Pharmaceuticals Inc.	2025-02-27	HUMAN PRESCRIPTION DRUG LABEL	4