FDA.reportPublic FDA data

PVP-Iodine Swabstick Threes

Product NDC
65517-0033
11-digit product format
655170033
Labeler code
65517
Product ID
65517-0033_43f8dcdb-1cc7-7f1d-e063-6394a90ad1b6
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-Iodine Swabstick Threes
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
5af20b49-11b1-4b15-bb7f-eccda2c46997Available 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
65517-0033-1PVP-Iodine Swabstick Threes1 in 1 POUCHSWAB19
65517-0033-1PVP-Iodine Swabstick Threes1000 in 1 CASESWAB10009
65517-0033-3PVP-Iodine Swabstick Threes3 in 1 POUCHSWAB39
65517-0033-3PVP-Iodine Swabstick Threes500 in 1 CASESWAB5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0033PVP-IODINE SWABSTICK THREES (POVIDONE-IODINE) SWAB [DUKAL LLC]8Current NDC, Legacy NDC, 4 package rows20240229_5af20b49-11b1-4b15-bb7f-eccda2c46997.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-Iodine Swabstick ThreesPOVIDONE-IODINEDukal LLC5af20b49-11b1-4b15-bb7f-eccda2c469972025-11-19WarningsExact identifier
ndc (product): 65517-0033

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN5af20b49-11b1-4b15-bb7f-eccda2c469979
797730povidone-iodine 100 MG/ML Medicated PadSCD5af20b49-11b1-4b15-bb7f-eccda2c469979
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY5af20b49-11b1-4b15-bb7f-eccda2c469979
797730povidone-iodine 10 % Medicated PadSY5af20b49-11b1-4b15-bb7f-eccda2c469979
797730povidone-iodine 10 % Medicated SwabstickSY5af20b49-11b1-4b15-bb7f-eccda2c469979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-0033-1655170033011000 POUCH in 1 CASE (65517-0033-1) / 1 APPLICATOR in 1 POUCH / 2.3 mL in 1 APPLICATOR1000 pouch2018-01-310000-00-00NoNoCurrent
65517-0033-365517003303500 POUCH in 1 CASE (65517-0033-3) / 3 APPLICATOR in 1 POUCH / 1.8 mL in 1 APPLICATOR500 pouch2018-01-310000-00-00NoNoCurrent