Major Oral Rinse

Product NDC
55154-3573
11-digit product format
551543573
Labeler code
55154
Product ID
55154-3573_94c97345-4786-4df9-a5f1-f10c292ed76c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
0.12% Chlorhexidine Gluconate
Dosage form
RINSE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA077789
Marketing category
ANDA
Marketing start
2020-11-20
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1.2 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Major Oral Rinse
Listing expiration
2027-12-31

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
55154-3573-5Major Oral Rinse15 mL in 1 CUP, UNIT-DOSERINSE156
55154-3573-5Major Oral Rinse5 in 1 BAGRINSE56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3573MAJOR ORAL RINSE (0.12% CHLORHEXIDINE GLUCONATE) RINSE [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20240928_772889a1-fc68-4400-9612-6fa51d0b6878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN772889a1-fc68-4400-9612-6fa51d0b68786
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD772889a1-fc68-4400-9612-6fa51d0b68786
834127chlorhexidine gluconate 0.12 % MouthwashSY772889a1-fc68-4400-9612-6fa51d0b68786
834127chlorhexidine gluconate 0.12 % Oral RinseSY772889a1-fc68-4400-9612-6fa51d0b68786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-3573-5551543573055 CUP, UNIT-DOSE in 1 BAG (55154-3573-5) / 15 mL in 1 CUP, UNIT-DOSE2020-11-200000-00-00NoNoCurrent