FDA.reportPublic FDA data

Povidone-Iodine Prep Sterile

Product NDC
63517-254
11-digit product format
635170254
Labeler code
63517
Product ID
63517-254_09c732f6-0bf8-b95e-e063-6394a90aa53b
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SWAB
Route
TOPICAL
Labeler
Cardinal Health 200 LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-29
Substance
POVIDONE-IODINE
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Povidone-Iodine Prep Sterile
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/g

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
6f5ac6b5-389d-473b-8398-176e48adc1b5Available 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
63517-254-21Povidone-Iodine Prep Sterile4.5 g in 1 POUCHSWAB4.53

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1
IODINEACTIVE MOIETY9679TC07X4POVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPOVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPOVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1
NONOXYNOL-10INACTIVE INGREDIENTK7O76887APPOVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1
POTASSIUM IODIDEINACTIVE INGREDIENT1C4QK22F9JPOVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-254POVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH 200 LLC]3Current NDC, Legacy NDC, 1 package rows20231213_6f5ac6b5-389d-473b-8398-176e48adc1b5.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
Povidone-Iodine Prep SterilePOVIDONE-IODINECardinal Health 200 LLC6f5ac6b5-389d-473b-8398-176e48adc1b52023-11-10WarningsExact identifier
ndc (product): 63517-254

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN6f5ac6b5-389d-473b-8398-176e48adc1b53
797730povidone-iodine 100 MG/ML Medicated PadSCD6f5ac6b5-389d-473b-8398-176e48adc1b53
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY6f5ac6b5-389d-473b-8398-176e48adc1b53
797730povidone-iodine 10 % Medicated PadSY6f5ac6b5-389d-473b-8398-176e48adc1b53
797730povidone-iodine 10 % Medicated SwabstickSY6f5ac6b5-389d-473b-8398-176e48adc1b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63517-254-21635170254214.5 g in 1 POUCH (63517-254-21) 4.5 g2015-04-290000-00-00NoNoCurrent