FDA.reportPublic FDA data

PVP-I Prep Pads foil-foil

Product NDC
65517-0034
11-digit product format
655170034
Labeler code
65517
Product ID
65517-0034_43f8f628-3b3b-1295-e063-6294a90aa4ca
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
2018-01-31
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 foil-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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
95c35c0d-bebb-46d0-8e97-f3d2541723adAvailable 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
65517-0034-1PVP-I Prep Pads foil-foil8000 in 1 CASESWAB800010
65517-0034-1PVP-I Prep Pads foil-foil0.5 mL in 1 POUCHSWAB0.510
65517-0034-2PVP-I Prep Pads foil-foil4000 in 1 CASESWAB400010
65517-0034-2PVP-I Prep Pads foil-foil0.5 mL in 1 POUCHSWAB0.510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0034PVP-I PREP PADS FOIL-FOIL (POVIDONE-IODINE) SWAB [DUKAL LLC]9Current NDC, Legacy NDC, 4 package rows20240229_95c35c0d-bebb-46d0-8e97-f3d2541723ad.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 foil-foilPOVIDONE-IODINEDukal LLC95c35c0d-bebb-46d0-8e97-f3d2541723ad2025-11-19WarningsExact identifier
ndc (product): 65517-0034

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN95c35c0d-bebb-46d0-8e97-f3d2541723ad10
797730povidone-iodine 100 MG/ML Medicated PadSCD95c35c0d-bebb-46d0-8e97-f3d2541723ad10
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY95c35c0d-bebb-46d0-8e97-f3d2541723ad10
797730povidone-iodine 10 % Medicated PadSY95c35c0d-bebb-46d0-8e97-f3d2541723ad10
797730povidone-iodine 10 % Medicated SwabstickSY95c35c0d-bebb-46d0-8e97-f3d2541723ad10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-0034-1655170034018000 POUCH in 1 CASE (65517-0034-1) / .5 mL in 1 POUCH8000 pouch2018-01-310000-00-00NoNoCurrent
65517-0034-2655170034024000 POUCH in 1 CASE (65517-0034-2) / .5 mL in 1 POUCH4000 pouch2018-01-310000-00-00NoNoCurrent