FDA.reportPublic FDA data

PVP-I Prep Pads paper-foil

Product NDC
65517-0039
11-digit product format
655170039
Labeler code
65517
Product ID
65517-0039_43f8ffc3-adc4-a8e3-e063-6394a90ad682
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Dukal LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-15
Substance
POVIDONE-IODINE
Active strength
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
PVP-I Prep Pads paper-foil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 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
f4596b0c-0e04-d71a-e053-2995a90a3b20Available 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
65517-0039-1PVP-I Prep Pads paper-foil0.5 mL in 1 APPLICATORSWAB0.54
65517-0039-1PVP-I Prep Pads paper-foil1 in 1 POUCHSWAB14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0039PVP-I PREP PADS PAPER-FOIL (POVIDONE-IODINE) SWAB [DUKAL LLC]3Current NDC, 2 package rows20231014_f4596b0c-0e04-d71a-e053-2995a90a3b20.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
PVP-I Prep Pads paper-foilPOVIDONE-IODINEDukal LLCf4596b0c-0e04-d71a-e053-2995a90a3b202025-11-19WarningsExact identifier
ndc (product): 65517-0039

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65517-0039-1655170039011 APPLICATOR in 1 POUCH (65517-0039-1) / .5 mL in 1 APPLICATOR1 applicator2023-02-15NoNoCurrent