Chlorhexidine Gluconate Oral Rinse

Product NDC
68071-3630
11-digit product format
680713630
Labeler code
68071
Product ID
68071-3630_1b1ca163-8860-2b1c-e063-6294a90a1572
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate Oral Rinse
Dosage form
SOLUTION
Route
DENTAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075561
Marketing category
ANDA
Marketing start
2023-07-27
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 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
68071-3630-6Chlorhexidine Gluconate Oral Rinse473 mL in 1 BOTTLESOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3630CHLORHEXIDINE GLUCONATE ORAL RINSE SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240619_1b1c9dc5-bd3d-d611-e063-6294a90a245d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN1b1c9dc5-bd3d-d611-e063-6294a90a245d1
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD1b1c9dc5-bd3d-d611-e063-6294a90a245d1
834127chlorhexidine gluconate 0.12 % MouthwashSY1b1c9dc5-bd3d-d611-e063-6294a90a245d1
834127chlorhexidine gluconate 0.12 % Oral RinseSY1b1c9dc5-bd3d-d611-e063-6294a90a245d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3630-668071363006473 mL in 1 BOTTLE (68071-3630-6) 473 ml2024-06-17NoNoCurrent