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 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
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

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