CHLORHEXIDINE GLUCONATE

Product NDC
0374-5080
11-digit product format
003745080
Labeler code
0374
Product ID
0374-5080_7e7b458d-c301-5055-e053-2a91aa0aa93b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorhexidine gluconate
Dosage form
RINSE
Route
ORAL
Labeler
Lyne Laboratories, Inc.
Application
ANDA074291
Marketing category
ANDA
Marketing start
2017-11-01
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
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0374-5080-01CHLORHEXIDINE GLUCONATE15 mL in 1 CUP, UNIT-DOSERINSE154
0374-5080-02CHLORHEXIDINE GLUCONATE473 mL in 1 BOTTLERINSE4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0374-5080CHLORHEXIDINE GLUCONATE RINSE [LYNE LABORATORIES, INC.]4Current NDC, Legacy NDC, 2 package rows20190103_0348006f-b818-4465-a896-bc0d42294cf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN0348006f-b818-4465-a896-bc0d42294cf44
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD0348006f-b818-4465-a896-bc0d42294cf44
834127chlorhexidine gluconate 0.12 % MouthwashSY0348006f-b818-4465-a896-bc0d42294cf44
834127chlorhexidine gluconate 0.12 % Oral RinseSY0348006f-b818-4465-a896-bc0d42294cf44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0374-5080-010037450800115 mL in 1 CUP, UNIT-DOSE (0374-5080-01) 15 ml2017-11-010000-00-00NoNoCurrent
0374-5080-0200374508002473 mL in 1 BOTTLE (0374-5080-02) 473 ml2017-11-010000-00-00NoNoCurrent