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 4 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Den-mat Holdings, Llc	a2d2d555-89a5-42d7-81d5-50fd7e741f83	2023-02-09	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Darby Dental Supply, LLC	0f8bc307-3069-45f2-aa03-8a4178d562a9	2023-01-12	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	9dc6d487-b51b-985b-e053-2995a90a8823	2022-12-26	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	9dc69556-aebe-1270-e053-2a95a90a69a9	2022-12-26	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	9dc6d545-f831-9692-e053-2995a90adec5	2022-12-26	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Scrub, Scrub-Stat, Foam Safe, Micro-Guard	CHLORHEXIDINE GLUCONATE	AVA, Inc.	9dc60323-ed7c-199a-e053-2995a90a74b8	2022-12-26	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Proficient Rx LP	504735e2-b13b-41c4-b2ed-5991f53b6fb6	2022-12-01	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	4c133721-ad9a-4807-8ad5-c3efdff1ec52	2022-11-28	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHG Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	SC Johnson Professional USA, Inc.	46084e90-6ffa-4e1a-a8ff-1c1b1484fe88	2022-11-28	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Sky Oral Rinse	CHLORHEXIDINE GLUCONATE	McKesson	b479c166-899b-0565-e053-2995a90a2094	2022-09-26	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	VistaPharm, LLC	7fb18b56-a76d-4f15-9438-c941def76fdb	2022-01-19	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Periogard Alcohol Free	CHLORHEXIDINE GLUCONATE	Colgate Oral Pharmaceuticals, Inc.	4993fc4a-bbe2-5ccb-de4d-44d73d484d39	2021-10-14	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Periogard Alcohol Free	CHLORHEXIDINE GLUCONATE	Colgate Oral Pharmaceuticals, Inc.	1aaad8d7-b6be-43a2-b3a2-12501a2fcdca	2020-11-18	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3a4cfe-88e2-0a10-e054-00144ff88e88	2020-03-23	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	47057d87-e142-222a-e054-00144ff8d46c	2020-03-23	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Lyne Laboratories, Inc.	0348006f-b818-4465-a896-bc0d42294cf4	2019-01-02	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6e62eb50-ebaa-361e-e053-2991aa0aba6f	2018-06-11	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