FDA.reportPublic FDA data

Dukal Povidone-Iodine Scrub Winged Sponges

Product NDC
65517-0037
11-digit product format
655170037
Labeler code
65517
Product ID
65517-0037_43f8fa99-4703-1636-e063-6294a90a6028
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine Scrub Winged Sponges
Dosage form
SPONGE
Route
TOPICAL
Labeler
Dukal LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-15
Substance
POVIDONE-IODINE
Active strength
1.1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dukal Povidone-Iodine Scrub Winged Sponges
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1.1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8bce905-929e-30e4-e053-2a95a90a909fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-0037-1Dukal Povidone-Iodine Scrub Winged Sponges2 in 1 POUCHSPONGE25
65517-0037-1Dukal Povidone-Iodine Scrub Winged Sponges109 mL in 1 APPLICATORSPONGE1095
65517-0037-2Dukal Povidone-Iodine Scrub Winged Sponges4 in 1 POUCHSPONGE45
65517-0037-2Dukal Povidone-Iodine Scrub Winged Sponges109 mL in 1 APPLICATORSPONGE1095

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0037DUKAL POVIDONE-IODINE SCRUB WINGED SPONGES (POVIDONE-IODINE SCRUB WINGED SPONGES) SPONGE [DUKAL LLC]4Current NDC, Legacy NDC, 4 package rows20231014_e8bce905-929e-30e4-e053-2a95a90a909f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dukal Povidone-Iodine Scrub Winged SpongesPOVIDONE-IODINE SCRUB WINGED SPONGESDukal LLCe8bce905-929e-30e4-e053-2a95a90a909f2025-11-19WarningsExact identifier
ndc (product): 65517-0037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-0037-1655170037012 APPLICATOR in 1 POUCH (65517-0037-1) / 109 mL in 1 APPLICATOR2 applicator2022-09-150000-00-00NoNoCurrent
65517-0037-2655170037024 APPLICATOR in 1 POUCH (65517-0037-2) / 109 mL in 1 APPLICATOR4 applicator2023-03-15NoNoCurrent