DASH Chlorhexidine Gluconate 0.12% Oral Rinse

Product NDC
69339-138
11-digit product format
693390138
Labeler code
69339
Product ID
69339-138_2e6b1725-1082-4541-9725-2fb49ae15817
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate 0.12% Oral Rinse
Dosage form
LIQUID
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA074291
Marketing category
ANDA
Marketing start
2018-04-25
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
DASH 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
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
69339-138-15DASH Chlorhexidine Gluconate 0.12% Oral Rinse15 mL in 1 CUP, UNIT-DOSELIQUID152
69339-138-17DASH Chlorhexidine Gluconate 0.12% Oral Rinse600 mL in 1 DOSE PACKLIQUID6002
69339-138-19DASH Chlorhexidine Gluconate 0.12% Oral Rinse1500 mL in 1 DOSE PACKLIQUID15002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-138-15ML - Milliliter69339-138dc111d59-4d4a-4b39-88ce-c634959b8e4e12018-05-09
69339-138-17ML - Milliliter69339-1385c0b9d71-0f46-40fa-997f-58d5e2c0d96d12018-05-09
69339-138-19ML - Milliliter69339-138734e9b9c-3125-46fb-8b8f-0fb07a2d2c2512018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-138DASH CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) LIQUID [NATCO PHARMA USA LLC]2Current NDC, Legacy NDC, 3 package rows20231031_12a11cd7-5087-4eb8-aa52-4fad402450f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN0253513c-148c-4be7-a6d5-5528f40806fa5
834127chlorhexidine gluconate 0.12 % Oral RinsePSNacc9ac8e-6f1c-4fcb-880d-dcc03d411ed35
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD0253513c-148c-4be7-a6d5-5528f40806fa5
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDacc9ac8e-6f1c-4fcb-880d-dcc03d411ed35
834127chlorhexidine gluconate 0.12 % MouthwashSY0253513c-148c-4be7-a6d5-5528f40806fa5
834127chlorhexidine gluconate 0.12 % MouthwashSYacc9ac8e-6f1c-4fcb-880d-dcc03d411ed35
834127chlorhexidine gluconate 0.12 % Oral RinseSY0253513c-148c-4be7-a6d5-5528f40806fa5
834127chlorhexidine gluconate 0.12 % Oral RinseSYacc9ac8e-6f1c-4fcb-880d-dcc03d411ed35
834127chlorhexidine gluconate 0.12 % Oral RinsePSN12a11cd7-5087-4eb8-aa52-4fad402450f72
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD12a11cd7-5087-4eb8-aa52-4fad402450f72
834127chlorhexidine gluconate 0.12 % MouthwashSY12a11cd7-5087-4eb8-aa52-4fad402450f72
834127chlorhexidine gluconate 0.12 % Oral RinseSY12a11cd7-5087-4eb8-aa52-4fad402450f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-138-156933901381515 mL in 1 CUP, UNIT-DOSE (69339-138-15) 15 ml2018-04-250000-00-00NoNoCurrent
69339-138-1769339013817600 mL in 1 DOSE PACK (69339-138-17) 600 ml2018-04-250000-00-00NoNoCurrent
69339-138-19693390138191500 mL in 1 DOSE PACK (69339-138-19) 1500 ml2018-04-250000-00-00NoNoCurrent