Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System

Product NDC
53462-009
11-digit product format
534620009
Labeler code
53462
Product ID
53462-009_8e71bf01-8708-1ddb-e053-2995a90abe6a
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE
Dosage form
KIT
Labeler
Sage Products, LLC
Application
NDA021669
Marketing category
NDA
Marketing start
2016-12-28
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-009-242021-01-29C16284748780-1ba0f9c33-2749-a910-e053-dadaa90a0b85Nose to Toes: Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-009-24Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System1 in 1 KITKIT15
53462-375-60Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System7 mL in 1 PACKETRINSE7 mL0.5 mg in 1mL5
53462-705-23Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System6 in 1 PACKAGECLOTH6500 mg5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-009SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC]5Legacy NDC, 3 package rows20190725_46f82c35-88bb-4f06-abf4-5250e7173aa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53462-009-24534620009241 in 1 KITHistorical
53462-375-60534620375607 mL in 1 PACKET7 mlHistorical
53462-705-23534620705236 in 1 PACKAGEHistorical