Home NDC 0121-0893 CHLORHEXIDINE GLUCONATE
Product NDC 0121-0893
11-digit product format 001210893
Labeler code 0121
Product ID 0121-0893_0b2578ba-9a50-4316-a225-196ff2fac285
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORHEXIDINE GLUCONATE
Dosage form RINSE
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA074522
Marketing category ANDA
Marketing start 1995-12-15
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074522-001 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074522-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074522-001 CHLORHEXIDINE GLUCONATE 0.12% SOLUTION / DENTAL AT 1995-12-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-0893-00 CHLORHEXIDINE GLUCONATE 10 in 1 TRAY RINSE 10 10 0121-0893-00 CHLORHEXIDINE GLUCONATE 10 in 1 CASE RINSE 10 10 0121-0893-15 CHLORHEXIDINE GLUCONATE 15 mL in 1 CUP, UNIT-DOSE RINSE 15 10 0121-0893-16 CHLORHEXIDINE GLUCONATE 473 mL in 1 BOTTLE RINSE 473 10 0121-0893-40 CHLORHEXIDINE GLUCONATE 10 in 1 TRAY RINSE 10 10 0121-0893-40 CHLORHEXIDINE GLUCONATE 4 in 1 CASE RINSE 4 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0893 CHLORHEXIDINE GLUCONATE RINSE [PAI HOLDINGS, LLC DBA PAI PHARMA] 8 Current NDC, Legacy NDC, 6 package rows 20240517_d3c2d8a7-bad5-410f-af83-e78a45e4b93f.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 1 of 1 · 1 matching rows.
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 0121-0893-00 00121089300 10 TRAY in 1 CASE (0121-0893-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15) 10 tray 2020-09-18 0000-00-00 No No Current 0121-0893-04 00121089304 118 mL in 1 BOTTLE (0121-0893-04) 118 ml 2020-09-18 0000-00-00 No No Current 0121-0893-15 00121089315 15 mL in 1 CUP, UNIT-DOSE 15 ml Historical 0121-0893-16 00121089316 473 mL in 1 BOTTLE (0121-0893-16) 473 ml 2020-09-18 0000-00-00 No No Current 0121-0893-40 00121089340 4 TRAY in 1 CASE (0121-0893-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15) 4 tray 2020-09-18 0000-00-00 No No Current