Chlorhexidine Gluconate

Product NDC
0116-0175
11-digit product format
001160175
Labeler code
0116
Product ID
0116-0175_50749dac-78e5-2cec-e063-6394a90ac90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2009-06-18
Marketing end
2028-01-31
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1.2 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorhexidine Gluconate

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
0116-0175-16Chlorhexidine Gluconate473 mL in 1 BOTTLE, PLASTICRINSE47313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0175CHLORHEXIDINE GLUCONATE RINSE [XTTRIUM LABORATORIES, INC.]12Current NDC, Legacy NDC, 1 package rows20250503_4a3a4cfe-88e0-0a10-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN4a3a4cfe-88e0-0a10-e054-00144ff88e8813
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD4a3a4cfe-88e0-0a10-e054-00144ff88e8813
834127chlorhexidine gluconate 0.12 % MouthwashSY4a3a4cfe-88e0-0a10-e054-00144ff88e8813
834127chlorhexidine gluconate 0.12 % Oral RinseSY4a3a4cfe-88e0-0a10-e054-00144ff88e8813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-0175-1600116017516473 mL in 1 BOTTLE, PLASTIC (0116-0175-16) 473 ml2009-06-182028-01-31NoNoCurrent