FDA.reportPublic FDA data

Prep non sterile

Product NDC
59050-455
11-digit product format
590500455
Labeler code
59050
Product ID
59050-455_0a3e519c-ecd6-d487-e063-6294a90a1f47
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
PATCH
Route
TOPICAL
Labeler
Changzhou Maokang Medical Products Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-29
Substance
POVIDONE-IODINE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Prep non sterile
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 g/100g

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
ecbe037b-77da-4ffc-8c60-e56f428766afAvailable 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
59050-455-10Prep non sterile5.5 g in 1 POUCHPATCH5.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-455PREP NON STERILE (POVIDONE-IODINE) PATCH [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]4Current NDC, Legacy NDC, 1 package rows20231116_ecbe037b-77da-4ffc-8c60-e56f428766af.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
Prep non sterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdecbe037b-77da-4ffc-8c60-e56f428766af2023-11-15WarningsExact identifier
ndc (product): 59050-455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59050-455-10590500455105.5 g in 1 POUCH (59050-455-10) 5.5 g2018-06-290000-00-00NoNoCurrent