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 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 brand name: Chlorhexidine Gluconate 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 brand name: Chlorhexidine Gluconate 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 · 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