FDA.reportPublic FDA data

Povidone Iodine Prep Solution Sterile

Product NDC
34645-0013
11-digit product format
346450013
Labeler code
34645
Product ID
34645-0013_085d0195-7031-e123-e063-6294a90ab344
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
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
Povidone Iodine Prep Solution Sterile
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
95f8489e-05fa-4f0f-acd6-0c426009080eAvailable 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
34645-0013-1Povidone Iodine Prep Solution Sterile30 mL in 1 POUCHSOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0013POVIDONE IODINE PREP SOLUTION STERILE (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]3Current NDC, Legacy NDC, 1 package rows20231023_95f8489e-05fa-4f0f-acd6-0c426009080e.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
Povidone Iodine Prep Solution SterilePOVIDONE-IODINEJianerkang Medical Co., Ltd95f8489e-05fa-4f0f-acd6-0c426009080e2023-10-23WarningsExact identifier
ndc (product): 34645-0013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN95f8489e-05fa-4f0f-acd6-0c426009080e3
312564povidone-iodine 100 MG/ML Topical SolutionSCD95f8489e-05fa-4f0f-acd6-0c426009080e3
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY95f8489e-05fa-4f0f-acd6-0c426009080e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0013-13464500130130 mL in 1 POUCH (34645-0013-1) 30 ml2021-01-010000-00-00NoNoCurrent