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 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
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
141c3490-3f52-9246-e063-6394a90a553cAvailable 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
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

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
MediChoice PVP Prep SolutionPOVIDONE-IODINEO&M HALYARD, INC.141c3490-3f52-9246-e063-6394a90a553c2025-10-09WarningsExact identifier
ndc (product): 39892-0841

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