Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System

Product NDC
53462-110
11-digit product format
534620110
Labeler code
53462
Product ID
53462-110_47f315d7-002d-0030-e054-00144ff8d46c
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
E
Listing certified through
2018-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-110-292020-01-31C16284748780-19d75b9d0-f4c0-f424-e053-dadaa90a57ceNose to Toes: Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-110-29Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System1 in 1 KITKIT12
53462-375-60Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System7 mL in 1 PACKETRINSE7 mL0.5 mg in 1mL2
53462-375-60Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System1 in 1 KITRINSE0.5 mg in 1mL2
53462-705-23Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System6 in 1 PACKAGECLOTH6500 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-110SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC]2Legacy NDC, 4 package rows20170207_a12eefb3-1130-4644-895e-d219613d7e41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53462-110-29534620110291 in 1 KITHistorical
53462-375-60534620375607 mL in 1 PACKET7 mlHistorical
53462-705-23534620705236 in 1 PACKAGEHistorical