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 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 brand name: Chlorhexidine Gluconate 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 brand name: Chlorhexidine Gluconate 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 brand name: Chlorhexidine Gluconate 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 brand name: Chlorhexidine Gluconate 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 brand name: Chlorhexidine Gluconate generic name: CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE Lyne Laboratories, Inc. 0348006f-b818-4465-a896-bc0d42294cf4 2019-01-02 Warnings, Adverse reactions Name fallback brand name: CHLORHEXIDINE GLUCONATE 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 · 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