FDA.reportPublic FDA data

MediChoice PVP Prep Solution

Product NDC
39892-0841
11-digit product format
398920841
Labeler code
39892
Product ID
39892-0841_40b41165-0932-b065-e063-6294a90a53ee
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-25
Substance
POVIDONE-IODINE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MediChoice PVP Prep Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui312564

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
39892-0841-1MediChoice PVP Prep Solution118 mL in 1 PACKAGESOLUTION1182
39892-0841-2MediChoice PVP Prep Solution118 mL in 1 BOTTLESOLUTION1182
39892-0841-2MediChoice PVP Prep Solution48 in 1 CASESOLUTION482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0841MEDICHOICE PVP PREP SOLUTION (POVIDONE-IODINE) SOLUTION [OWENS & MINOR DISTRIBUTION, INC.]1Current NDC, 3 package rows20240322_141c3490-3f52-9246-e063-6394a90a553c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN141c3490-3f52-9246-e063-6394a90a553c2
312564povidone-iodine 100 MG/ML Topical SolutionSCD141c3490-3f52-9246-e063-6394a90a553c2
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY141c3490-3f52-9246-e063-6394a90a553c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39892-0841-139892084101118 mL in 1 PACKAGE (39892-0841-1) 118 ml2024-01-25NoNoCurrent
39892-0841-23989208410248 BOTTLE in 1 CASE (39892-0841-2) / 118 mL in 1 BOTTLE48 bottle2024-01-25NoNoCurrent