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 Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui797730

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

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