Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC
68999-650
11-digit product format
689990650
Labeler code
68999
Product ID
68999-650_47f94c38-483e-2001-e063-6394a90a9d05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorhexidine Gluconate 0.12% 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-650-24Chlorhexidine Gluconate 0.12% Oral Rinse10 in 1 TRAYSOLUTION101
68999-650-24Chlorhexidine Gluconate 0.12% Oral Rinse2 in 1 BOXSOLUTION21
68999-650-51Chlorhexidine Gluconate 0.12% Oral Rinse15 mL in 1 CUPSOLUTION151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-650-24ML - Milliliter68999-6501a9f0326-98cc-4bba-9c10-3c1245b8e82812026-04-20
68999-650-51ML - Milliliter68999-650ce895da7-340b-4882-a45f-95eeb13bf63b12026-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-650-24689990650242 TRAY in 1 BOX (68999-650-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-650-51) 2 tray2026-01-08NoNoHistorical
68999-650-516899906505115 mL in 1 CUP15 mlHistorical