Chlorhexidine Gluconate

Product NDC
66689-106
11-digit product format
666890106
Labeler code
66689
Product ID
66689-106_5674e1f6-64de-4e08-990e-d3e7cbcd3070
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
BUCCAL
Labeler
VistaPharm, LLC
Application
ANDA203212
Marketing category
ANDA
Marketing start
2022-01-24
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

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorhexidine Gluconate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE1.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E
Rxcui834127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-106-502024-01-30C16284748780-11030e365-04cf-111a-e063-dadaa90a10e2Chlorhexidine Gluconate Oral Rinse USP, 0.12%
66689-106-992024-01-30C16284748780-11030e365-04cf-111a-e063-dadaa90a10e2Chlorhexidine Gluconate Oral Rinse USP, 0.12%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66689-106-01Chlorhexidine Gluconate15 mL in 1 CUP, UNIT-DOSERINSE153
66689-106-50Chlorhexidine Gluconate50 in 1 CASERINSE503
66689-106-99Chlorhexidine Gluconate100 in 1 CASERINSE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-106-01ML - Milliliter66689-106a6207d48-959f-4124-aadc-5218e715ea1e12022-02-07
66689-106-50ML - Milliliter66689-106bbafd471-e81f-4fc8-8edd-2d81717d651c12022-02-07
66689-106-99ML - Milliliter66689-10636820dce-441a-4043-8288-89de9506d7f112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-106CHLORHEXIDINE GLUCONATE RINSE [VISTAPHARM, LLC]3Current NDC, Legacy NDC, 3 package rows20240209_7fb18b56-a76d-4f15-9438-c941def76fdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN7fb18b56-a76d-4f15-9438-c941def76fdb3
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD7fb18b56-a76d-4f15-9438-c941def76fdb3
834127chlorhexidine gluconate 0.12 % MouthwashSY7fb18b56-a76d-4f15-9438-c941def76fdb3
834127chlorhexidine gluconate 0.12 % Oral RinseSY7fb18b56-a76d-4f15-9438-c941def76fdb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-106-016668901060115 mL in 1 CUP, UNIT-DOSE15 mlHistorical
66689-106-506668901065050 CUP, UNIT-DOSE in 1 CASE (66689-106-50) / 15 mL in 1 CUP, UNIT-DOSE (66689-106-01) 2022-01-240000-00-00NoNoCurrent
66689-106-9966689010699100 CUP, UNIT-DOSE in 1 CASE (66689-106-99) / 15 mL in 1 CUP, UNIT-DOSE (66689-106-01) 2022-01-240000-00-00NoNoCurrent