NUPRO Chlorhexidine Gluconate

Product NDC
0116-0800
11-digit product format
001160800
Labeler code
0116
Product ID
0116-0800_34009d15-bb1b-9b7e-e063-6294a90ae5e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE
Dosage form
RINSE
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2017-01-17
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
NUPRO 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, 1869723

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-0800-16NUPRO Chlorhexidine Gluconate473 mL in 1 BOTTLERINSE4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0800NUPRO CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE) RINSE [XTTRIUM LABORATORIES, INC.]7Current NDC, Legacy NDC, 1 package rows20250503_4a3b87bc-d913-6c88-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN4a3b87bc-d913-6c88-e054-00144ff8d46c7
1869723Nupro Chlorhexidine 0.12 % Oral RinsePSN4a3b87bc-d913-6c88-e054-00144ff8d46c7
1869723chlorhexidine gluconate 1.2 MG/ML Mouthwash [Nupro Chlorhexidine]SBD4a3b87bc-d913-6c88-e054-00144ff8d46c7
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD4a3b87bc-d913-6c88-e054-00144ff8d46c7
834127chlorhexidine gluconate 0.12 % MouthwashSY4a3b87bc-d913-6c88-e054-00144ff8d46c7
834127chlorhexidine gluconate 0.12 % Oral RinseSY4a3b87bc-d913-6c88-e054-00144ff8d46c7
1869723Nupro Chlorhexidine 0.12 % MouthwashSY4a3b87bc-d913-6c88-e054-00144ff8d46c7
1869723Nupro Chlorhexidine 1.2 MG/ML MouthwashSY4a3b87bc-d913-6c88-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-0800-1600116080016473 mL in 1 BOTTLE (0116-0800-16) 473 ml2017-01-170000-00-00NoNoCurrent