FDA.reportPublic FDA data

3M DuraPrep Surgical

Product NDC
17518-011
11-digit product format
175180011
Labeler code
17518
Product ID
17518-011_6f88810b-2554-4c4f-8604-25fe4b695a2d
Type
HUMAN OTC DRUG
Nonproprietary name
Iodine Povacrylex and Isopropyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Solventum US LLC
Application
NDA021586
Marketing category
NDA
Marketing start
2006-09-29
Substance
IODINE POVACRYLEX; ISOPROPYL ALCOHOL
Active strength
6.02; 636.4 mg/mL; 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 DuraPrep Surgical
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODINE POVACRYLEX6.02 mg/mL
ISOPROPYL ALCOHOL636.4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E43AWY083, ND2M416302
Rxcui692866, 1090522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17518-011-072024-01-30C16284748780-11030e365-3819-111a-e063-dadaa90a10e222a10a54-6a04-48b3-9ec4-b26526183daf
17518-011-082024-01-30C16284748780-11030e365-1bb7-111a-e063-dadaa90a10e2c951336f-9cb2-40cc-98f3-b5c4d9f5e27d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17518-011-073M DuraPrep Surgical6 mL in 1 APPLICATORSOLUTION613
17518-011-073M DuraPrep Surgical1 in 1 CASESOLUTION113
17518-011-083M DuraPrep Surgical26 mL in 1 APPLICATORSOLUTION2613
17518-011-083M DuraPrep Surgical1 in 1 CASESOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17518-011-07ML - Milliliter17518-0118194a988-b389-48ca-868b-d294b1be4feb12015-10-02
17518-011-08ML - Milliliter17518-011cebc176f-bd3a-4bea-8b7e-3b62f9db762b12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Iodine povacrylexACTIVE INGREDIENT6E43AWY0833M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE ]1
Isopropyl alcoholACTIVE INGREDIENTND2M4163023M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE ]1
IodineACTIVE MOIETY9679TC07X43M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE ]1
Isopropyl alcoholACTIVE MOIETYND2M4163023M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE ]1
alcoholINACTIVE INGREDIENT3K9958V90M3M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE ]1
waterINACTIVE INGREDIENT059QF0KO0R3M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17518-0113M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [SOLVENTUM US LLC]11Current NDC, Legacy NDC, 4 package rows20250223_22a10a54-6a04-48b3-9ec4-b26526183daf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090522DuraPrep 0.7 % / 74 % Topical SolutionPSN22a10a54-6a04-48b3-9ec4-b26526183daf13
692866iodine povacrylex 0.7 % / isopropyl alcohol 74 % Topical SolutionPSN22a10a54-6a04-48b3-9ec4-b26526183daf13
1090522iodine povacrylex 7 MG/ML / isopropyl alcohol 0.74 ML/ML Topical Solution [DuraPrep]SBD22a10a54-6a04-48b3-9ec4-b26526183daf13
692866iodine povacrylex 7 MG/ML / isopropyl alcohol 0.74 ML/ML Topical SolutionSCD22a10a54-6a04-48b3-9ec4-b26526183daf13
1090522DuraPrep (iodine 0.7 % / isopropyl alcohol 74 % ) Topical SolutionSY22a10a54-6a04-48b3-9ec4-b26526183daf13
692866iodine povacrylex 0.7 % / isopropyl alcohol 74 % Topical SolutionSY22a10a54-6a04-48b3-9ec4-b26526183daf13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17518-011-07175180011071 APPLICATOR in 1 CASE (17518-011-07) / 6 mL in 1 APPLICATOR1 applicator2006-09-290000-00-00NoNoCurrent
17518-011-08175180011081 APPLICATOR in 1 CASE (17518-011-08) / 26 mL in 1 APPLICATOR1 applicator2006-09-290000-00-00NoNoCurrent