Home NDC 53329-301 Chlorhexidine Gluconate
Product NDC 53329-301
11-digit product format 533290301
Labeler code 53329
Product ID 53329-301_596cf04b-565a-df10-e063-6294a90aef32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorhexidine Gluconate
Dosage form RINSE
Route ORAL
Labeler Medline Industries, LP
Application ANDA077789
Marketing category ANDA
Marketing start 2010-08-05
Substance CHLORHEXIDINE GLUCONATE
Active strength 1.2 mg/mL
Pharmacologic classes Decreased Cell Wall Integrity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-301-24 Chlorhexidine Gluconate 15 mL in 1 BOTTLE RINSE 15 10 53329-301-30 Chlorhexidine Gluconate 100 in 1 CASE RINSE 100 10 53329-301-61 Chlorhexidine Gluconate 80 in 1 CASE RINSE 80 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORHEXIDINE GLUCONATE ACTIVE INGREDIENT MOR84MUD8E CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2 CHLORHEXIDINE ACTIVE MOIETY R4KO0DY52L CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2 PEG-40 SORBITAN DIISOSTEARATE INACTIVE INGREDIENT JL4CCU7I1G CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-301 CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, LP] 9 Current NDC, Legacy NDC, 3 package rows 20230817_92eddf00-7e23-4d5b-b5cd-38af99ad9e56.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 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Marketing end Sample Exclude flag Status 53329-301-24 53329030124 15 mL in 1 BOTTLE (53329-301-24) 15 ml 2010-08-05 0000-00-00 No No Current 53329-301-30 53329030130 100 BOTTLE in 1 CASE (53329-301-30) / 15 mL in 1 BOTTLE (53329-301-24) 100 bottle 2022-01-01 No No Current 53329-301-61 53329030161 80 BOTTLE in 1 CASE (53329-301-61) > 15 mL in 1 BOTTLE (53329-301-24) 80 bottle 2010-08-05 0000-00-00 No No Current