Home Applications 074356 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 RLD / RS 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# 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 brand name: CHLORHEXIDINE GLUCONATE 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 brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE ATLANTIC BIOLOGICALS CORP. ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c 2025-05-12 Warnings, Adverse reactions Name fallback brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE Atlantic Biologicals Corps. b445d769-a9e3-f72a-fbab-d485457996d0 2025-05-12 Warnings, Adverse reactions Name fallback brand name: Chlorhexidine Gluconate 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 brand name: Chlorhexidine Gluconate 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