Home NDC 17856-2001 Chlorhexidine Gluconate
Product NDC 17856-2001
11-digit product format 178562001
Labeler code 17856
Product ID 17856-2001_34f38b12-df79-8be0-e063-6394a90a330c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorhexidine Gluconate
Dosage form RINSE
Route ORAL
Labeler Atlantic Biologicals Corps.
Application ANDA077789
Marketing category ANDA
Marketing start 2009-08-01
Substance CHLORHEXIDINE GLUCONATE
Active strength 1.2 mg/mL
Pharmacologic classes Decreased Cell Wall Integrity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17856-2001-5 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17856-2001-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17856-2001-5 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17856-2001-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-2001-5 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-2001-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-2001-5 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-2001-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-2001-5 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-2001-3 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-2001-5 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-2001-3 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-2001-5 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-2001-3 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17856-2001-5 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17856-2001-3 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17856-2001-5 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17856-2001-3 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17856-2001-5 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17856-2001-3 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17856-2001-5 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17856-2001-3 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-2001-5 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-2001-3 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-2001-5 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-2001-3 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-2001-5 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-2001-3 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-2001-5 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-2001-3 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-2001-5 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-2001-3 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-2001-5 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-2001-3 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-2001-5 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-2001-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-2001-5 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-2001-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 17856-2001-3 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 17856-2001-5 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A077789-001 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077789-001 AT
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 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077789-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 2009-06-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Chlorhexidine Gluconate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORHEXIDINE GLUCONATE 1.2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MOR84MUD8E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 834127 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-2001-3 Chlorhexidine Gluconate 10 mL in 1 CUP RINSE 10 4 17856-2001-5 Chlorhexidine Gluconate 5 mL in 1 CUP RINSE 5 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-2001 CHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS.] 4 Current NDC, Legacy NDC, 2 package rows 20250514_b445d769-a9e3-f72a-fbab-d485457996d0.zip
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 2 · 26 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 Exact identifier application applno (ANDA): 077789 application number: ANDA077789 Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE Darby Dental Supply, LLC 0f8bc307-3069-45f2-aa03-8a4178d562a9 2023-01-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077789 application number: ANDA077789 Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE Proficient Rx LP 504735e2-b13b-41c4-b2ed-5991f53b6fb6 2022-12-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077789 application number: ANDA077789 Sky Oral Rinse CHLORHEXIDINE GLUCONATE McKesson b479c166-899b-0565-e053-2995a90a2094 2022-09-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077789 application number: ANDA077789 Chlorhexidine Gluconate 0.12% Oral Rinse CHLORHEXIDINE GLUCONATE Xttrium Laboratories, Inc. 4a3a4cfe-88e2-0a10-e054-00144ff88e88 2020-03-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077789 application number: ANDA077789 Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE Xttrium Laboratories, Inc. 47057d87-e142-222a-e054-00144ff8d46c 2020-03-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077789 application number: ANDA077789
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 17856-2001-3 17856200103 10 mL in 1 CUP (17856-2001-3) 10 ml 2016-07-22 No No Current 17856-2001-5 17856200105 5 mL in 1 CUP (17856-2001-5) 5 ml 2016-07-22 No No Current