FDA.reportPublic FDA data

PVP-I Pouch foil-foil

Product NDC
65517-0035
11-digit product format
655170035
Labeler code
65517
Product ID
65517-0035_43f8ee7b-b7fb-b4ce-e063-6294a90a2500
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Dukal LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-31
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PVP-I Pouch foil-foil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 g/100mL

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
45aefabf-5283-411a-b509-749977635938Available 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
65517-0035-1PVP-I Pouch foil-foil22 mL in 1 POUCHSOLUTION2213
65517-0035-1PVP-I Pouch foil-foil500 in 1 CASESOLUTION50013
65517-0035-2PVP-I Pouch foil-foil29.57 mL in 1 POUCHSOLUTION29.5713
65517-0035-2PVP-I Pouch foil-foil250 in 1 CASESOLUTION25013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0035PVP-I POUCH FOIL-FOIL (POVIDONE-IODINE) SOLUTION [DUKAL LLC]12Current NDC, Legacy NDC, 4 package rows20240229_45aefabf-5283-411a-b509-749977635938.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
PVP-I Pouch foil-foilPOVIDONE-IODINEDukal LLC45aefabf-5283-411a-b509-7499776359382025-11-19WarningsExact identifier
ndc (product): 65517-0035

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN45aefabf-5283-411a-b509-74997763593813
312564povidone-iodine 100 MG/ML Topical SolutionSCD45aefabf-5283-411a-b509-74997763593813
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY45aefabf-5283-411a-b509-74997763593813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-0035-165517003501500 POUCH in 1 CASE (65517-0035-1) / 22 mL in 1 POUCH500 pouch2018-01-310000-00-00NoNoCurrent
65517-0035-265517003502250 POUCH in 1 CASE (65517-0035-2) / 29.57 mL in 1 POUCH250 pouch2018-11-090000-00-00NoNoCurrent