FDA.reportPublic FDA data

3M Skin and Nasal Antiseptic

Product NDC
17518-060
11-digit product format
175180060
Labeler code
17518
Product ID
17518-060_6d533c62-2530-4a3c-91e7-e17fecd9b074
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Solventum US LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-07-01
Substance
POVIDONE-IODINE
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
3M Skin and Nasal Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui252965

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
17518-060-043M Skin and Nasal Antiseptic1 in 1 POUCHSOLUTION110
17518-060-043M Skin and Nasal Antiseptic12 in 1 CARTONSOLUTION1210
17518-060-04Skin antisepsis, oral cleansing, nasal antisepsis4 mL in 1 BOTTLESOLUTION4 mL5 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17518-060-04EA - Each17518-06087da09da-00f8-4da0-aca0-5f3802b38dbc12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Povidone-IodineACTIVE INGREDIENT85H0HZU99M3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
IodineACTIVE MOIETY9679TC07X43M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
lactic acidINACTIVE INGREDIENT33X04XA5AT3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
Lauramidopropylamine OxideINACTIVE INGREDIENTI6KX160QTV3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
malic acidINACTIVE INGREDIENT817L1N4CKP3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32I3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
sodium iodideINACTIVE INGREDIENTF5WR8N145C3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
steareth-100INACTIVE INGREDIENT4OH5W9UM873M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
waterINACTIVE INGREDIENT059QF0KO0R3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
xylitolINACTIVE INGREDIENTVCQ006KQ1E3M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [3M HEALTH CARE]2
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
17518-0603M SKIN AND NASAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [SOLVENTUM US LLC]9Current NDC, Legacy NDC, 2 package rows20240808_1a94494d-7dd3-4f32-bc42-81c199fe233e.zip
17518-060SKIN ANTISEPSIS, ORAL CLEANSING AND NASAL ANTISEPSIS SYSTEM (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, LLC]2Current NDC, Legacy NDC20170207_a12eefb3-1130-4644-895e-d219613d7e41.zip
17518-060SKIN 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
252965povidone-iodine 5 % Topical SolutionPSN1a94494d-7dd3-4f32-bc42-81c199fe233e10
252965povidone-iodine 50 MG/ML Topical SolutionSCD1a94494d-7dd3-4f32-bc42-81c199fe233e10
252965povidone-iodine 5 % (titratable iodine 0.5 % ) Topical SolutionSY1a94494d-7dd3-4f32-bc42-81c199fe233e10
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
17518-060-041751800600412 POUCH in 1 CARTON (17518-060-04) / 1 BOTTLE in 1 POUCH / 4 mL in 1 BOTTLE12 pouch2009-07-010000-00-00NoNoCurrent