FDA.reportPublic FDA data

Povidone Iodine

Product NDC
34645-1043
Requested package NDC
34645-1043-1
11-digit product format
346451043
Labeler code
34645
Product ID
34645-1043_085e7fe4-e6a2-9dd9-e063-6294a90a9d87
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-11
Substance
POVIDONE-IODINE
Active strength
.1 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE.1 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbe0d44d-8752-44e6-acad-f8deeebdbf17Available 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
34645-1043-1Povidone Iodine21 mL in 1 APPLICATORSWAB214
34645-1043-1Povidone Iodine1 in 1 POUCHSWAB14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]1
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]1
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUPOVIDONE IODINE SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOVIDONE IODINE SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-1043POVIDONE IODINE SWAB [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231024_bbe0d44d-8752-44e6-acad-f8deeebdbf17.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 IodinePOVIDONE IODINEJianerkang Medical Co., Ltdbbe0d44d-8752-44e6-acad-f8deeebdbf172023-10-23WarningsExact identifier
ndc (package): 34645-1043-1
ndc (product): 34645-1043
ndc11 (package): 34645104301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-1043-1346451043011 APPLICATOR in 1 POUCH (34645-1043-1) / 21 mL in 1 APPLICATOR1 applicator2015-06-110000-00-00NoNoCurrent