FDA.reportPublic FDA data

Povidone-Iodine Prep Sterile

Product NDC
59050-658
11-digit product format
590500658
Labeler code
59050
Product ID
59050-658_0c6746b7-c400-05e3-e063-6394a90a9d80
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SPONGE
Route
TOPICAL
Labeler
Changzhou Maokang Medical Products Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-27
Substance
POVIDONE-IODINE
Active strength
100 mg/g
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
Povidone-Iodine Prep Sterile
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/g

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
bb62784a-d7b7-471e-9aed-0c6d2e349c3aAvailable 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
59050-658-11Povidone-Iodine Prep Sterile2 in 1 POUCHSPONGE24
59050-658-11Povidone-Iodine Prep Sterile10 in 1 BOXSPONGE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-658POVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SPONGE [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]4Current NDC, 2 package rows20231214_bb62784a-d7b7-471e-9aed-0c6d2e349c3a.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 SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdbb62784a-d7b7-471e-9aed-0c6d2e349c3a2023-12-13WarningsExact identifier
ndc (product): 59050-658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59050-658-115905006581110 POUCH in 1 BOX (59050-658-11) / 2 PATCH in 1 POUCH / 80 g in 1 PATCH10 pouch2015-04-27NoNoCurrent