Home NDC 0904-7035 Chlorhexidine Gluconate
Product NDC 0904-7035
11-digit product format 009047035
Labeler code 0904
Product ID 0904-7035_4ffb1fdb-d485-22f8-e063-6394a90ad365
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorhexidine Gluconate
Dosage form RINSE
Route DENTAL
Labeler Major Pharmaceuticals
Application ANDA077789
Marketing category ANDA
Marketing start 2020-11-20
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 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 0904-7035-80 Major Oral Rinse 1500 mL in 1 PACKAGE RINSE 1500 4 0904-7035-87 Major Oral Rinse 600 mL in 1 PACKAGE RINSE 600 4 0904-7035-88 Major Oral Rinse 15 mL in 1 CUP, UNIT-DOSE RINSE 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7035 MAJOR ORAL RINSE (0.12% CHLORHEXIDINE GLUCONATE) RINSE [MAJOR PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 3 package rows 20221221_b48e69dc-0913-423f-e053-2a95a90a53df.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 0904-7035-80 00904703580 10 TRAY in 1 CASE (0904-7035-80) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0904-7035-88) 10 tray 2020-11-20 0000-00-00 No No Current 0904-7035-87 00904703587 4 TRAY in 1 CASE (0904-7035-87) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0904-7035-88) 4 tray 2020-11-20 0000-00-00 No No Current 0904-7035-88 00904703588 15 mL in 1 CUP, UNIT-DOSE (0904-7035-88) 15 ml 2020-11-20 0000-00-00 No No Current