FDA.reportPublic FDA data

Povidone-Iodine Prep Sterile

Product NDC
63517-251
11-digit product format
635170251
Labeler code
63517
Product ID
63517-251_09c732f6-0be8-b95e-e063-6394a90aa53b
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SWAB
Route
TOPICAL
Labeler
Cardinal Health 200, Inc
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 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
63517-251-21Povidone-Iodine Prep Sterile1 in 1 POUCHSWAB14
63517-251-21Povidone-Iodine Prep Sterile50 in 1 BOXSWAB504

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
63517-251POVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SWAB [CARDINAL HEALTH 200, INC]4Current NDC, Legacy NDC, 2 package rows20231111_b123606d-b131-466a-ab20-9dded97bb5a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSNb123606d-b131-466a-ab20-9dded97bb5a14
797730povidone-iodine 100 MG/ML Medicated PadSCDb123606d-b131-466a-ab20-9dded97bb5a14
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYb123606d-b131-466a-ab20-9dded97bb5a14
797730povidone-iodine 10 % Medicated PadSYb123606d-b131-466a-ab20-9dded97bb5a14
797730povidone-iodine 10 % Medicated SwabstickSYb123606d-b131-466a-ab20-9dded97bb5a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63517-251-216351702512150 POUCH in 1 BOX (63517-251-21) / 1 PATCH in 1 POUCH / 2 g in 1 PATCH50 pouch2015-04-290000-00-00NoNoCurrent