FDA.reportPublic FDA data

CHLORHEXIDINE GLUCONATE

Product NDC
53462-705
11-digit product format
534620705
Labeler code
53462
Product ID
53462-705_45c31000-edfe-4387-e063-6394a90aeb61
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Sage Products LLC
Application
NDA021669
Marketing category
NDA
Marketing start
2006-02-01
Substance
CHLORHEXIDINE GLUCONATE
Active strength
500 mg/1
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE500 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-705-20CHLORHEXIDINE GLUCONATE2 in 1 PACKAGECLOTH221
53462-705-23CHLORHEXIDINE GLUCONATE6 in 1 PACKAGECLOTH621
53462-705-26CHLORHEXIDINE GLUCONATE6 in 1 PACKAGECLOTH621
53462-705-23Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System6 in 1 PACKAGECLOTH6500 mg5
53462-705-23Skin antisepsis, oral cleansing, nasal antisepsis6 in 1 PACKAGECLOTH6500 mg3
53462-705-23Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System6 in 1 PACKAGECLOTH6500 mg2
53462-705-23Skin antisepsis, oral cleansing, nasal antisepsis6 in 1 PACKAGECLOTH6500 mg1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53462-705-20EA - Each53462-70507f8a3cf-9379-4359-bae1-02cecd93793c12012-07-24
53462-705-23EA - Each53462-7053d90eac6-c72f-4444-b4d0-c4ea1b1b88f012012-07-24
53462-705-26EA - Each53462-7058ee590b2-e855-4f04-8861-4ed0d0b878fc12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
chlorhexidine gluconateACTIVE INGREDIENTMOR84MUD8ECHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
chlorhexidineACTIVE MOIETYR4KO0DY52LCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
gluconolactoneINACTIVE INGREDIENTWQ29KQ9POTCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
nonoxynol-9INACTIVE INGREDIENT48Q180SH9TCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
waterINACTIVE INGREDIENT059QF0KO0RCHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]9
chlorhexidine gluconateACTIVE INGREDIENTMOR84MUD8ESKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
chlorhexidine gluconateACTIVE INGREDIENTMOR84MUD8ESKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
chlorhexidineACTIVE MOIETYR4KO0DY52LSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
chlorhexidineACTIVE MOIETYR4KO0DY52LSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
IODINEACTIVE MOIETY9679TC07X4SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
IODINEACTIVE MOIETY9679TC07X4SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
gluconolactoneINACTIVE INGREDIENTWQ29KQ9POTSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
gluconolactoneINACTIVE INGREDIENTWQ29KQ9POTSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
LAURAMIDOPROPYLAMINE OXIDEINACTIVE INGREDIENTI6KX160QTVSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
LAURAMIDOPROPYLAMINE OXIDEINACTIVE INGREDIENTI6KX160QTVSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
nonoxynol-9INACTIVE INGREDIENT48Q180SH9TSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
nonoxynol-9INACTIVE INGREDIENT48Q180SH9TSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
PEG-40 SORBITAN DIISOSTEARATEINACTIVE INGREDIENTJL4CCU7I1GSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
SODIUM IODIDEINACTIVE INGREDIENTF5WR8N145CSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
SODIUM IODIDEINACTIVE INGREDIENTF5WR8N145CSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RSKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ESKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ESKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-705CHLORHEXIDINE GLUCONATE CLOTH [SAGE PRODUCTS LLC]19Current NDC, Legacy NDC, 3 package rows20241103_bdb6a012-37e5-4664-84a3-134bea284744.zip
53462-705SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC]5Current NDC, Legacy NDC20190725_46f82c35-88bb-4f06-abf4-5250e7173aa6.zip
53462-705SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS LLC]3Current NDC, Legacy NDC20190530_6ea1691d-5379-f0c0-1b37-ecf08f6dbc00.zip
53462-705SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC]2Current NDC, Legacy NDC20170207_a12eefb3-1130-4644-895e-d219613d7e41.zip
53462-705SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1Current NDC, Legacy NDC20121026_d36bf0aa-9dec-3328-cab8-8fc6748dafb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
846127chlorhexidine gluconate 2 % Medicated PadPSNbdb6a012-37e5-4664-84a3-134bea28474421
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCDbdb6a012-37e5-4664-84a3-134bea28474421
846127chlorhexidine gluconate 2 % Medicated PadSYbdb6a012-37e5-4664-84a3-134bea28474421
1251617cetylpyridinium chloride 0.05 % MouthwashPSN46f82c35-88bb-4f06-abf4-5250e7173aa65
846127chlorhexidine gluconate 2 % Medicated PadPSN46f82c35-88bb-4f06-abf4-5250e7173aa65
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD46f82c35-88bb-4f06-abf4-5250e7173aa65
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCD46f82c35-88bb-4f06-abf4-5250e7173aa65
1251617cetylpyridinium chloride 0.05 % MouthwashSY46f82c35-88bb-4f06-abf4-5250e7173aa65
846127chlorhexidine gluconate 2 % Medicated PadSY46f82c35-88bb-4f06-abf4-5250e7173aa65
834127chlorhexidine gluconate 0.12 % Oral RinsePSN6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
846127chlorhexidine gluconate 2 % Medicated PadPSN6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
252965povidone-iodine 5 % Topical SolutionPSN6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCD6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
252965povidone-iodine 50 MG/ML Topical SolutionSCD6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
834127chlorhexidine gluconate 0.12 % MouthwashSY6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
834127chlorhexidine gluconate 0.12 % Oral RinseSY6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
846127chlorhexidine gluconate 2 % Medicated PadSY6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
252965povidone-iodine 5 % (titratable iodine 0.5 % ) Topical SolutionSY6ea1691d-5379-f0c0-1b37-ecf08f6dbc003
1251617cetylpyridinium chloride 0.05 % MouthwashPSNa12eefb3-1130-4644-895e-d219613d7e412
846127chlorhexidine gluconate 2 % Medicated PadPSNa12eefb3-1130-4644-895e-d219613d7e412
252965povidone-iodine 5 % Topical SolutionPSNa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDa12eefb3-1130-4644-895e-d219613d7e412
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCDa12eefb3-1130-4644-895e-d219613d7e412
252965povidone-iodine 50 MG/ML Topical SolutionSCDa12eefb3-1130-4644-895e-d219613d7e412
1251617cetylpyridinium chloride 0.05 % MouthwashSYa12eefb3-1130-4644-895e-d219613d7e412
846127chlorhexidine gluconate 2 % Medicated PadSYa12eefb3-1130-4644-895e-d219613d7e412
252965povidone-iodine 5 % (titratable iodine 0.5 % ) Topical SolutionSYa12eefb3-1130-4644-895e-d219613d7e412
846127chlorhexidine gluconate 2 % Medicated PadPSNd36bf0aa-9dec-3328-cab8-8fc6748dafb31
252965povidone-iodine 5 % Topical SolutionPSNd36bf0aa-9dec-3328-cab8-8fc6748dafb31
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCDd36bf0aa-9dec-3328-cab8-8fc6748dafb31
252965povidone-iodine 50 MG/ML Topical SolutionSCDd36bf0aa-9dec-3328-cab8-8fc6748dafb31
846127chlorhexidine gluconate 2 % Medicated PadSYd36bf0aa-9dec-3328-cab8-8fc6748dafb31
252965povidone-iodine 5 % (titratable iodine 0.5 % ) Topical SolutionSYd36bf0aa-9dec-3328-cab8-8fc6748dafb31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53462-705-20534620705202 CLOTH in 1 PACKAGE (53462-705-20) 2 cloth2006-02-010000-00-00NoNoCurrent
53462-705-23534620705236 CLOTH in 1 PACKAGE (53462-705-23) 6 cloth2006-02-010000-00-00NoNoCurrent
53462-705-26534620705266 CLOTH in 1 PACKAGE (53462-705-26) 6 cloth2006-02-010000-00-00NoNoCurrent