Chlorhexidine

Product NDC: 68071-2377
11-digit product format: 680712377
Labeler code: 68071
Product ID: 68071-2377_be5f9189-5fda-0204-e053-2a95a90aa341
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorhexidine Gluconate
Dosage form: SOLUTION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA074522
Marketing category: ANDA
Marketing start: 1995-12-15
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: 2022-12-31
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	68071-2377		U	Excluded because listing certification expired		2026-08-17
excluded package	package	68071-2377	68071-2377-6	U	Excluded because listing certification expired		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2377-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2377-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2377-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2377-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2377-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2377-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2377-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2377-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2377-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-2377-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-2377-6	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-2377-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-2377-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-2377-6	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-2377-6	`1332a3947898…`	`d4bfe170f9cd…`

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2377-6	2023-01-30	C162847	48780-1	f386c64a-10bb-0266-e053-dadaa90a7c1a	Chlorhexidine Gluconate Oral Rinse, 0.12%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2377-6	Chlorhexidine	473 mL in 1 BOTTLE	RINSE	473		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2377	CHLORHEXIDINE (CHLORHEXIDINE GLUCONATE) SOLUTION [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20210326_be5fdf87-cdcd-974a-e053-2995a90a2bba.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	be5fdf87-cdcd-974a-e053-2995a90a2bba	2
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	be5fdf87-cdcd-974a-e053-2995a90a2bba	2
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	be5fdf87-cdcd-974a-e053-2995a90a2bba	2
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	be5fdf87-cdcd-974a-e053-2995a90a2bba	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2377-6	68071237706	473 mL in 1 BOTTLE (68071-2377-6)	473 ml	2021-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorhexidine Gluconate Oral Rinse, 0.12%	NuCare Pharmaceuticals,Inc.	2024-03-25	HUMAN PRESCRIPTION DRUG LABEL	2