Chlorhexidine Gluconate, 0.12% Oral Rinse Solution

Product NDC
81033-512
11-digit product format
810330512
Labeler code
81033
Product ID
81033-512_2d91fb6c-a2a4-5fcf-e063-6294a90aa15c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate, 0.12% Oral Rinse
Dosage form
SOLUTION
Route
DENTAL
Labeler
Kesin Pharma Corporation
Application
ANDA075561
Marketing category
ANDA
Marketing start
2023-08-15
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, 0.12% Oral Rinse Solution
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
81033-512-15Chlorhexidine Gluconate, 0.12% Oral Rinse Solution15 mL in 1 CUP, UNIT-DOSESOLUTION154
81033-512-50Chlorhexidine Gluconate, 0.12% Oral Rinse Solution100 in 1 CARTONSOLUTION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-512-15ML - Milliliter81033-512f319a405-4bc6-4f26-824a-16c55631d9e512024-03-12
81033-512-50ML - Milliliter81033-512771d5677-b180-46be-a9cb-4c22317314c912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-512CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION (CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE) SOLUTION [KESIN PHARMA CORPORATION]4Current NDC, 2 package rows20250212_326c15fc-90d8-48de-abd0-61e0c4165529.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % MouthwashSY326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % Oral RinseSY326c15fc-90d8-48de-abd0-61e0c41655294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-512-158103305121515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
81033-512-5081033051250100 CUP, UNIT-DOSE in 1 CARTON (81033-512-50) / 15 mL in 1 CUP, UNIT-DOSE (81033-512-15) 2023-08-15NoNoHistorical