Chlorhexidine Gluconate

Product NDC
53329-301
11-digit product format
533290301
Labeler code
53329
Product ID
53329-301_410e373a-25a4-2b02-e063-6394a90aac25
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-301-24Chlorhexidine Gluconate15 mL in 1 BOTTLERINSE1510
53329-301-30Chlorhexidine Gluconate100 in 1 CASERINSE10010
53329-301-61Chlorhexidine Gluconate80 in 1 CASERINSE8010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-301-24ML - Milliliter53329-30160954001-3de9-4d81-a551-e3edb9b1629f12022-04-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-301CHLORHEXIDINE GLUCONATE RINSE [MEDLINE INDUSTRIES, LP]9Current NDC, Legacy NDC, 3 package rows20230817_92eddf00-7e23-4d5b-b5cd-38af99ad9e56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN92eddf00-7e23-4d5b-b5cd-38af99ad9e5610
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD92eddf00-7e23-4d5b-b5cd-38af99ad9e5610
834127chlorhexidine gluconate 0.12 % MouthwashSY92eddf00-7e23-4d5b-b5cd-38af99ad9e5610
834127chlorhexidine gluconate 0.12 % Oral RinseSY92eddf00-7e23-4d5b-b5cd-38af99ad9e5610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-301-245332903012415 mL in 1 BOTTLE (53329-301-24) 15 ml2010-08-050000-00-00NoNoCurrent
53329-301-3053329030130100 BOTTLE in 1 CASE (53329-301-30) / 15 mL in 1 BOTTLE (53329-301-24) 100 bottle2022-01-01NoNoHistorical
53329-301-615332903016180 BOTTLE in 1 CASE (53329-301-61) > 15 mL in 1 BOTTLE (53329-301-24) 80 bottle2010-08-050000-00-00NoNoCurrent