Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC
0116-0003
11-digit product format
001160003
Labeler code
0116
Product ID
0116-0003_a187f677-2f93-8f95-e053-2a95a90a4c59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE
Dosage form
LIQUID
Route
BUCCAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2014-01-20
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1.2 [iU]/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 0.12% Oral Rinse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE1.2 [iU]/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
0116-0003-15Chlorhexidine Gluconate 0.12% Oral Rinse15 mL in 1 BOTTLELIQUID155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0003CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]5Current NDC, Legacy NDC, 1 package rows20200327_4a3a4cfe-88e2-0a10-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN4a3a4cfe-88e2-0a10-e054-00144ff88e885
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD4a3a4cfe-88e2-0a10-e054-00144ff88e885
834127chlorhexidine gluconate 0.12 % MouthwashSY4a3a4cfe-88e2-0a10-e054-00144ff88e885
834127chlorhexidine gluconate 0.12 % Oral RinseSY4a3a4cfe-88e2-0a10-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-0003-150011600031515 mL in 1 BOTTLE (0116-0003-15) 15 ml2014-01-200000-00-00NoNoCurrent