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 2 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Periogard Alcohol Free	CHLORHEXIDINE GLUCONATE	ATLANTIC BIOLOGICALS CORP.	f927717e-e743-43c4-a2b3-d5b83f2403b0	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Rising Pharma Holdings, Inc.	d53a01eb-7213-4f19-b74f-acbf0fd54418	2026-02-10	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHG	CHLORHEXIDINE GLUCONATE	Xinxiang Xinda Technology Co.,Ltd	125ac9df-03db-83e9-e063-6394a90afeab	2026-01-08	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	20e79dbb-8f33-469d-a7ca-29afde16a8ee	2026-01-02	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub-Stat	CHLORHEXIDINE GLUCONATE	Ecolab Inc.	4b4b02c7-b44a-483e-8e6b-79d994037490	2025-12-31	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	Cardinal Health	7a7aeecf-ce26-5a66-e053-2991aa0ad4a2	2025-12-12	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	9f6342f7-faa3-4d23-a860-054d04cb8d42	2025-12-10	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
BD E-Z Scrub 107	CHLORHEXIDINE GLUCONATE	Becton Dickinson and Company	7c173111-11de-4585-af06-b329fe029036	2025-12-08	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Sage Products LLC	3c754532-d9a5-f876-00c4-05a4c9b21efa	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
foaming hand wash	CHLORHEXIDINE GLUCONATE	Medline Industries, LP	9b926809-65e9-4e5b-e053-2995a90add10	2025-09-08	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	5d49522f-63e5-4297-adf5-b5f3bd419d47	2025-07-09	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	da5d244d-e9c1-45a5-8f4e-ed1d3b9d02a9	2025-07-09	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a2c3c98-4e4e-1c9b-e054-00144ff88e88	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	ATLANTIC BIOLOGICALS CORP.	ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c	2025-05-12	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Atlantic Biologicals Corps.	b445d769-a9e3-f72a-fbab-d485457996d0	2025-05-12	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
NUPRO Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3b87bc-d913-6c88-e054-00144ff8d46c	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6e5f9616-ddf5-19c4-e053-2991aa0a372a	2025-04-30	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6e5e678f-3832-d201-e053-2a91aa0a5ea8	2025-04-30	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE	McKesson Medical-Surgical	626d7aa9-b8da-4254-9c57-9007ed4290d4	2025-01-16	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	NuCare Pharmaceuticals,Inc.	56e5e687-b1b5-6b43-e054-00144ff88e88	2024-12-31	Warnings, Adverse reactions	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