Home NDC 50383-720 Chlorhexidine Gluconate
Product NDC 50383-720
11-digit product format 503830720
Labeler code 50383
Product ID 50383-720_0ee39403-93d7-4f4a-95c0-0bae436c6a3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorhexidine Gluconate
Dosage form RINSE
Route ORAL
Labeler Akorn
Application ANDA074356
Marketing category ANDA
Marketing start 1996-05-07
Marketing end 0000-00-00
Substance CHLORHEXIDINE GLUCONATE
Active strength 1 mg/mL
Pharmacologic classes Decreased Cell Wall Integrity [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50383-720-15 Q2 Oral Care Kit with CHG 15 mL in 1 CUP, UNIT-DOSE RINSE 150 mL 1.2 mg in 1mL 1 50383-720-15 Q2 Oral Care Kit with CHG 10 in 1 TRAY RINSE 1.2 mg in 1mL 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORHEXIDINE GLUCONATE ACTIVE INGREDIENT MOR84MUD8E CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 CHLORHEXIDINE ACTIVE MOIETY R4KO0DY52L CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 PEG-40 SORBITAN DIISOSTEARATE INACTIVE INGREDIENT JL4CCU7I1G CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 WATER INACTIVE INGREDIENT 059QF0KO0R CHLORHEXIDINE GLUCONATE RINSE [HI-TECH PHARMACAL CO., INC.] 9 CHLORHEXIDINE GLUCONATE ACTIVE INGREDIENT MOR84MUD8E CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 Chlorhexidine Gluconate ACTIVE INGREDIENT MOR84MUD8E KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 CHLORHEXIDINE GLUCONATE ACTIVE INGREDIENT MOR84MUD8E CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 Hydrogen peroxide ACTIVE INGREDIENT BBX060AN9V KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 CHLORHEXIDINE ACTIVE MOIETY R4KO0DY52L CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 CHLORHEXIDINE ACTIVE MOIETY R4KO0DY52L CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 Chlorhexidine ACTIVE MOIETY R4KO0DY52L KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 Hydrogen peroxide ACTIVE MOIETY BBX060AN9V KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 FD&C Blue no. 1 INACTIVE INGREDIENT H3R47K3TBD KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 Mint INACTIVE INGREDIENT FV98Z8GITP KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 PEG-40 sorbitan diisostearate INACTIVE INGREDIENT JL4CCU7I1G KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 PEG-40 SORBITAN DIISOSTEARATE INACTIVE INGREDIENT JL4CCU7I1G CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 PEG-40 SORBITAN DIISOSTEARATE INACTIVE INGREDIENT JL4CCU7I1G CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 Saccharin Sodium Dihydrate INACTIVE INGREDIENT SB8ZUX40TY KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 Water INACTIVE INGREDIENT 059QF0KO0R KIMVENT ORAL CARE Q4 KIT WITH CHG (CHLORHEXIDINE GLUCONATE AND HYDROGEN PEROXIDE) KIT [HALYARD HEALTH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHLORHEXIDINE GLUCONATE RINSE [PREFERRED PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHLORHEXIDINE GLUCONATE RINSE [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-720 Q2 ORAL CARE KIT WITH CHG (HYDROGEN PEROXIDE AND CHLORHEXIDINE GLUCONATE) KIT [HALYARD HEALTH] 1 Legacy NDC 20160128_b2f446b9-9f9f-4380-b5dc-55e3a1c06fff.zip
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 50383-720-15 50383072015 15 mL in 1 CUP, UNIT-DOSE 15 ml Historical 50383-720-16 50383072016 473 mL in 1 BOTTLE, PLASTIC (50383-720-16) 473 ml 1996-05-07 0000-00-00 No No Current 50383-720-17 50383072017 4 TRAY in 1 CASE (50383-720-17) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (50383-720-15) 4 tray 2010-06-30 0000-00-00 No No Current 50383-720-19 50383072019 10 TRAY in 1 CASE (50383-720-19) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (50383-720-15) 10 tray 2010-06-30 0000-00-00 No No Current