FDA.reportPublic FDA data

Chlorhexidine Gluconate

Product NDC
17856-2001
11-digit product format
178562001
Labeler code
17856
Product ID
17856-2001_34f38b12-df79-8be0-e063-6394a90a330c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
ORAL
Labeler
Atlantic Biologicals Corps.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2009-08-01
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
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-2001-32025-05-02C16284748780-19d75b9d1-27de-f424-e053-dadaa90a57ceCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE
17856-2001-52025-05-02C16284748780-19d75b9d1-27de-f424-e053-dadaa90a57ceCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE
17856-2001-32020-01-31C16284748780-19d75b9d1-27de-f424-e053-dadaa90a57ceCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE
17856-2001-52020-01-31C16284748780-19d75b9d1-27de-f424-e053-dadaa90a57ceCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-2001-3Chlorhexidine Gluconate10 mL in 1 CUPRINSE104
17856-2001-5Chlorhexidine Gluconate5 mL in 1 CUPRINSE54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-2001-3ML - Milliliter17856-200107345558-f4be-4565-87e6-42a31d12896f12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1
WATERINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-2001CHLORHEXIDINE GLUCONATE RINSE [ATLANTIC BIOLOGICALS CORPS.]4Current NDC, Legacy NDC, 2 package rows20250514_b445d769-a9e3-f72a-fbab-d485457996d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSNb445d769-a9e3-f72a-fbab-d485457996d04
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCDb445d769-a9e3-f72a-fbab-d485457996d04
834127chlorhexidine gluconate 0.12 % MouthwashSYb445d769-a9e3-f72a-fbab-d485457996d04
834127chlorhexidine gluconate 0.12 % Oral RinseSYb445d769-a9e3-f72a-fbab-d485457996d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-2001-31785620010310 mL in 1 CUP (17856-2001-3) 10 ml2016-07-22NoNoHistorical
17856-2001-5178562001055 mL in 1 CUP (17856-2001-5) 5 ml2016-07-22NoNoHistorical