FDA.reportPublic FDA data

Application 021586

Type
NDA
Sponsor
3M

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLSPONGE;TOPICALEQ 0.7% IODINE;74% (6ML)YesYes
002DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLSPONGE;TOPICALEQ 0.7% IODINE;74% (26ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021586-001DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29
N021586-002DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29a50c72e98297…
2026-08-01 22:54:322026-06N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
application applno (NDA): 021586
application number: NDA021586
ndc (product): 17518-011

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M CompanyNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine Povacrylex and Isopropyl Alcohol3M CompanyNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M Health CareNDACurrent
17518-0113M DuraPrep SurgicalIodine povacrylex and Isopropyl alcohol3M CompanyNDACurrent
17518-0113M DuraPrep SurgicalIodine Povacrylex and Isopropyl Alcohol3M CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15825SUPPL2015-06-19
28182SUPPL2015-06-10
5785SUPPL2010-03-18
21745ORIG2008-08-22
5784ORIG2006-10-05