FDA.reportPublic FDA data

PVP-I Prep Pad

Product NDC
10819-3801
Requested package NDC
10819-3801-2
11-digit product format
108193801
Labeler code
10819
Product ID
10819-3801_57b02ea2-7b36-0b77-e063-6394a90acff5
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Professional Disposables International, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-22
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PVP-I Prep Pad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
57b02fbb-a9a6-0b8c-e063-6394a90a44f3Available on FDA.report

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
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsExact identifier
ndc (package): 10819-3801-2
ndc (product): 10819-3801
ndc11 (package): 10819380102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
10819-3801-210819380102100 PACKET in 1 BOX (10819-3801-2) / .485 mL in 1 PACKET (10819-3801-1)100 packet2026-06-220Current