Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC
62135-650
11-digit product format
621350650
Labeler code
62135
Product ID
62135-650_1935dfbf-e5dc-bc64-e063-6394a90ad2a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075006
Marketing category
ANDA
Marketing start
2004-03-03
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
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
62135-650-24Chlorhexidine Gluconate 0.12% Oral Rinse10 in 1 TRAYSOLUTION103
62135-650-24Chlorhexidine Gluconate 0.12% Oral Rinse2 in 1 BOXSOLUTION23
62135-650-51Chlorhexidine Gluconate 0.12% Oral Rinse15 mL in 1 CUPSOLUTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-650-24ML - Milliliter62135-6508662c2e0-010b-45ee-8487-1200a0fad93212024-09-09
62135-650-51ML - Milliliter62135-650449997c2-da78-4daf-9c7c-6d044d16881512024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-650CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE SOLUTION [CHARTWELL RX, LLC]3Current NDC, 3 package rows20240531_923e22b1-0fa2-4a3c-900d-2d2eb63f841c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN923e22b1-0fa2-4a3c-900d-2d2eb63f841c3
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD923e22b1-0fa2-4a3c-900d-2d2eb63f841c3
834127chlorhexidine gluconate 0.12 % MouthwashSY923e22b1-0fa2-4a3c-900d-2d2eb63f841c3
834127chlorhexidine gluconate 0.12 % Oral RinseSY923e22b1-0fa2-4a3c-900d-2d2eb63f841c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-650-24621350650242 TRAY in 1 BOX (62135-650-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-650-51) 2 tray2024-05-23NoNoCurrent
62135-650-516213506505115 mL in 1 CUP15 mlHistorical