Application 076434

Type: ANDA
Sponsor: SUNSTAR AMERICAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAROEX	CHLORHEXIDINE GLUCONATE	SOLUTION;DENTAL	0.12%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076434-001	PAROEX	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL			2005-11-29

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 · 43 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
2026-09-14 22:38:34	2026-08	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL	AT	2005-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076434-001	PAROEX	0.12%	SOLUTION / DENTAL		2005-11-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076434-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076434-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076434-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076434-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076434-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076434-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076434-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076434-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076434-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076434-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076434-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076434-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076434-001	AT	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A076434-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076434-001	AT	1	`cb3db0bc1861…`

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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUPRO Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"	d9d25abd-c3b4-4713-91c7-538f98e8fb70	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	29b547bf-c08e-14c2-e054-00144ff88e88	2024-12-23	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	4275eb53-1a7e-4a91-aac1-1085f40fac88	2024-12-23	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Hibiclens	CHLORHEXIDINE GLUCONATE	Molnlycke Health Care	8b37a721-79bb-4051-95a7-fcb4edebfcb7	2024-12-23	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Hibiclens	CHLORHEXIDINE GLUCONATE	Asclemed USA, Inc.	c7363108-0b4e-4d8a-9ec8-ea048604ecb2	2024-10-05	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	b4444803-034c-4e22-9a21-9e07207df36e	2024-10-03	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	c126e473-e9ae-4749-a5e9-07191ec8c1fb	2024-10-03	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Halyard Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Owens & Minor, Inc.	240c5de0-dc33-1bb8-e063-6394a90ac701	2024-09-04	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Halyard Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Owens & Minor, Inc.	262e1975-bf99-cd3f-e063-6394a90a0a5b	2024-09-04	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	1f1eebef-9aac-b847-e063-6394a90a26cc	2024-08-07	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Peridex	CHLORHEXIDINE GLUCONATE	Solventum US LLC	3fcd41c4-875a-4e54-b533-261f198011af	2024-08-01	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	A-S Medication Solutions	b589dcb9-883a-4f80-8f66-7a6c2051bf2a	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e3c8e79-230e-4dd3-e054-00144ff88e88	2024-05-02	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	34d15e72-8770-49dc-a514-d44ae4468a1e	2023-12-20	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
DYNA-HEX 4	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	245c41e6-a0f6-0825-e054-00144ff8d46c	2023-11-09	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e398787-7003-6502-e054-00144ff88e88	2023-11-03	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e3d67c6-180c-1d9c-e054-00144ff8d46c	2023-11-03	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	42b0a0a9-6c5e-45c7-e054-00144ff88e88	2023-11-03	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	3e3bcbd1-de23-4d86-e054-00144ff8d46c	2023-11-03	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	43401362-8e54-1f5d-e054-00144ff8d46c	2023-11-03	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0210	PAROEX	Chlorhexidine Gluconate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0210	PAROEX	Chlorhexidine Gluconate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0210	PAROEX	Chlorhexidine Gluconate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
52376-021	PAROEX	chlorhexidine gluconate	Sunstar Americas, Inc.	ANDA	Current
52376-021	PAROEX	chlorhexidine gluconate	Sunstar Americas, Inc.	ANDA	Current
68094-028	Paroex Chlorhexidine Gluconate	Chlorhexidine Gluconate	Precision Dose, Inc.	ANDA	Current
68094-028	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Precision Dose, Inc.	ANDA	Current
70166-027	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Lohxa	ANDA	Current
70166-027	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Lohxa	ANDA	Current