Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC
0116-6720
11-digit product format
001166720
Labeler code
0116
Product ID
0116-6720_340158b9-5070-ed62-e063-6394a90aa4df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form
LIQUID
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2013-02-01
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
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse
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
0116-6720-04Acclean Chlorhexidine Gluconate 0.12% Oral Rinse118 mL in 1 BOTTLELIQUID11817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-6720ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [XTTRIUM LABORATORIES, INC.]16Current NDC, Legacy NDC, 1 package rows20220915_4a2a6bb8-85b0-6c36-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN4a2a6bb8-85b0-6c36-e054-00144ff8d46c17
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD4a2a6bb8-85b0-6c36-e054-00144ff8d46c17
834127chlorhexidine gluconate 0.12 % MouthwashSY4a2a6bb8-85b0-6c36-e054-00144ff8d46c17
834127chlorhexidine gluconate 0.12 % Oral RinseSY4a2a6bb8-85b0-6c36-e054-00144ff8d46c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-6720-0400116672004118 mL in 1 BOTTLE (0116-6720-04) 118 ml2016-08-220000-00-00NoNoCurrent