Chlorhexidine Gluconate, 0.12% Oral Rinse Solution

Product NDC
61037-469
11-digit product format
610370469
Labeler code
61037
Product ID
61037-469_0dfd551e-3e6f-769f-e063-6294a90ad610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Dosage form
SOLUTION
Route
DENTAL
Labeler
Bajaj Medical, LLC
Application
ANDA075561
Marketing category
ANDA
Marketing start
2021-11-17
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
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
61037-469-02Chlorhexidine Gluconate, 0.12% Oral Rinse Solution118 mL in 1 BOTTLESOLUTION1184
61037-469-03Chlorhexidine Gluconate, 0.12% Oral Rinse Solution473 mL in 1 BOTTLESOLUTION4734
61037-469-05Chlorhexidine Gluconate, 0.12% Oral Rinse Solution1893 mL in 1 JUGSOLUTION18934
61037-469-07Chlorhexidine Gluconate, 0.12% Oral Rinse Solution15 mL in 1 CUP, UNIT-DOSESOLUTION154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61037-469CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION SOLUTION [BAJAJ MEDICAL, LLC]4Current NDC, Legacy NDC, 4 package rows20240103_d44f4e79-e684-a1ef-e053-2995a90a4620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % Oral RinsePSNd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 0.12 % MouthwashSY326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % MouthwashSYd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 0.12 % Oral RinseSY326c15fc-90d8-48de-abd0-61e0c41655294
834127chlorhexidine gluconate 0.12 % Oral RinseSYd44f4e79-e684-a1ef-e053-2995a90a46204
834127chlorhexidine gluconate 0.12 % Oral RinsePSN21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 0.12 % Oral RinsePSN27d81483-e58c-593d-e063-6394a90a0db43
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD27d81483-e58c-593d-e063-6394a90a0db43
834127chlorhexidine gluconate 0.12 % MouthwashSY21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 0.12 % MouthwashSY27d81483-e58c-593d-e063-6394a90a0db43
834127chlorhexidine gluconate 0.12 % Oral RinseSY21002357-1780-4a5d-ad54-9936f4a9c0313
834127chlorhexidine gluconate 0.12 % Oral RinseSY27d81483-e58c-593d-e063-6394a90a0db43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61037-469-0261037046902118 mL in 1 BOTTLE (61037-469-02) 118 ml2021-11-170000-00-00NoNoCurrent
61037-469-0361037046903473 mL in 1 BOTTLE (61037-469-03) 473 ml2021-11-170000-00-00NoNoCurrent
61037-469-05610370469051893 mL in 1 JUG (61037-469-05) 1893 ml2021-11-170000-00-00NoNoCurrent
61037-469-076103704690715 mL in 1 CUP, UNIT-DOSE (61037-469-07) 15 ml2021-11-170000-00-00NoNoCurrent