FDA.reportPublic FDA data

Skin antisepsis, oral cleansing, nasal antisepsis

Product NDC
53462-008
11-digit product format
534620008
Labeler code
53462
Product ID
53462-008_d36bf0aa-9dec-3328-cab8-8fc6748dafb3
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE
Dosage form
KIT
Labeler
Sage Products, Inc.
Application
NDA021669
Marketing category
NDA
Marketing start
2012-02-06
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-008-282020-01-31C16284748780-19d75b9d0-6748-f424-e053-dadaa90a57ce2% Chlorhexidine Gluconate Cloth and 3M Skin and Nasal Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17518-060-04Skin antisepsis, oral cleansing, nasal antisepsis4 mL in 1 BOTTLESOLUTION4 mL5 mg in 1mL1
53462-008-28Skin antisepsis, oral cleansing, nasal antisepsis1 in 1 KITKIT11
53462-705-23Skin antisepsis, oral cleansing, nasal antisepsis6 in 1 PACKAGECLOTH6500 mg1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
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
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
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
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
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
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSKIN 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
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
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-008SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.]1Legacy NDC, 3 package rows20121026_d36bf0aa-9dec-3328-cab8-8fc6748dafb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsStatus
17518-060-04175180060044 mL in 1 BOTTLE4 mlHistorical
53462-008-28534620008281 in 1 KITHistorical
53462-705-23534620705236 in 1 PACKAGEHistorical