Chlorhexidine

Product NDC: 81646-102
Requested package NDC: 81646-102-15
11-digit product format: 816460102
Labeler code: 81646
Product ID: 81646-102_88bf0894-235a-448c-bd95-a55ecb0d198f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorhexidine Gluconate
Dosage form: SOLUTION
Route: ORAL
Labeler: PINNACLE PHARMA LLC
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	81646-102	81646-102-15	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
81646-102-15	2023-01-30	C162847	48780-1	f386c64a-0e08-0266-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
81646-102-15	Chlorhexidine	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81646-102	CHLORHEXIDINE (CHLORHEXIDINE GLUCONATE) SOLUTION [PINNACLE PHARMA LLC]	3	Legacy NDC, 1 package rows	20210515_a6ebff38-0fdf-4cbf-a89a-acd487a253aa.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	a6ebff38-0fdf-4cbf-a89a-acd487a253aa	3
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	a6ebff38-0fdf-4cbf-a89a-acd487a253aa	3
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	a6ebff38-0fdf-4cbf-a89a-acd487a253aa	3
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	a6ebff38-0fdf-4cbf-a89a-acd487a253aa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81646-102-15	81646010215	15 mL in 1 CUP, UNIT-DOSE (81646-102-15)	15 ml	1995-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorhexidine Gluconate Oral Rinse, 0.12%	PINNACLE PHARMA LLC	2021-03-25	HUMAN PRESCRIPTION DRUG LABEL	3