Application 074356

Type: ANDA
Sponsor: HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORHEXIDINE GLUCONATE	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
A074356-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL			1996-05-07

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	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1996-05-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074356-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		1996-05-07	`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	A074356-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074356-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074356-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074356-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074356-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074356-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074356-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074356-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074356-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074356-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074356-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074356-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074356-001	AT	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074356-001	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 1 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	PAI Holdings, LLC dba PAI Pharma	d3c2d8a7-bad5-410f-af83-e78a45e4b93f	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: CHLORHEXIDINE GLUCONATE generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Medline Industries, LP	92eddf00-7e23-4d5b-b5cd-38af99ad9e56	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Sage Products LLC	bdb6a012-37e5-4664-84a3-134bea284744	2026-06-16	Warnings	Name fallback brand name: CHLORHEXIDINE GLUCONATE generic name: CHLORHEXIDINE GLUCONATE
Sponge with 4% w/w chlorhexidine gluconate (CHG)	CHLORHEXIDINE GLUCONATE	Xinxiang Xinda Technology Co.,Ltd	53f4dd22-e4ab-5d8a-e063-6294a90a8c39	2026-06-11	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Swab Applicator Brushes 4% w/w chlorhexidine gluconate (CHG)	CHLORHEXIDINE GLUCONATE	XINXIANG XINDA TECHNOLOGY CO.,LTD	51c1a74f-c6a8-b831-e063-6294a90a6c71	2026-05-24	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Swab Stick 2% w/w chlorhexidine gluconate (CHG)	CHLORHEXIDINE GLUCONATE	XINXIANG XINDA TECHNOLOGY CO.,LTD	51c5a926-d137-9119-e063-6294a90a8845	2026-05-24	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Dyna-Hex 4	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	0a32c299-f7ca-d15c-e063-6294a90af2c1	2026-04-30	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Major Pharmaceuticals	b48e69dc-0913-423f-e053-2a95a90a53df	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Benco Dental	21b03b2a-44ee-41c0-e054-00144ff8d46c	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a6403ad-fa5e-2b4a-e054-00144ff8d46c	2026-04-28	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3a4cfe-88e0-0a10-e054-00144ff88e88	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a9eda34-d85c-4b66-e054-00144ff88e88	2026-04-27	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3a684f-5f72-347a-e054-00144ff8d46c	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE
DYNA-HEX 2	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63	2026-04-27	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Preferred Pharmaceuticals, Inc.	1c3401ef-6a7a-485e-ab7e-52420a36f4e2	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Safco Dental Supply LLC	0d950be9-9d25-202c-e063-6294a90ada7d	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Safco Dental Supply LLC	0d9624f6-2a0b-c30f-e063-6294a90ae717	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%	CHLORHEXIDINE GLUCONATE	Henry Schein, Inc.	4b0b50ef-78e1-5595-e063-6294a90aa84d	2026-02-17	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%	CHLORHEXIDINE GLUCONATE	Henry Schein, Inc.	4b0c6bcd-2242-f734-e063-6294a90a8fbf	2026-02-17	Warnings	Name fallback generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%	CHLORHEXIDINE GLUCONATE	Henry Schein, Inc.	4b0d7b42-5757-6248-e063-6394a90a94c5	2026-02-17	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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-720	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Akorn	ANDA	Current
50383-720	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-720	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
55118-978	Kimvent	Hydrogen peroxide and Chlorhexidine Gluconate	Halyard Health	ANDA	Current
55154-9625	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Cardinal Health	ANDA	Current
63187-524	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Proficient Rx LP	ANDA	Current
63187-524	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Proficient Rx LP	ANDA	Current
68788-9426	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9426	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Preferred Pharmaceuticals, Inc.	ANDA	Current
69697-976	KIMVENT	Chlorhexidine Gluconate and Hydrogen Peroxide	Halyard Health	ANDA	Current
69697-982	Q2 Oral Care Kit with CHG	Hydrogen peroxide and Chlorhexidine Gluconate	Halyard Health	ANDA	Current