FDA.reportPublic FDA data

Medline

Product NDC
53329-120
11-digit product format
533290120
Labeler code
53329
Product ID
53329-120_1cea06a9-c416-d705-e063-6394a90a87ef
Type
HUMAN OTC DRUG
Nonproprietary name
povidone-iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
Substance
POVIDONE-IODINE
Active strength
10 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
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 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
1300277Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11fd1661-1b8c-b65b-e063-6394a90af89bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-120-05Medline250 in 1 CASESWAB2502
53329-120-05Medline1 in 1 POUCHSWAB12
53329-120-09Medline10 mL in 1 APPLICATORSWAB102
53329-120-09Medline1 in 1 POUCHSWAB12
53329-120-26Medline4 in 1 BOXSWAB42
53329-120-26Medline1 in 1 POUCHSWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-120MEDLINE (POVIDONE-IODINE) SWAB [MEDLINE INDUSTRIES, LP]2Current NDC, 6 package rows20240725_11fd1661-1b8c-b65b-e063-6394a90af89b.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
MedlinePOVIDONE-IODINEMedline Industries, LP11fd1661-1b8c-b65b-e063-6394a90af89b2024-07-01WarningsExact identifier
ndc (product): 53329-120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300277povidone-iodine gel 10 % Medicated PadPSN11fd1661-1b8c-b65b-e063-6394a90af89b2
1300277povidone-iodine 0.1 MG/MG Medicated PadSCD11fd1661-1b8c-b65b-e063-6394a90af89b2
1300277povidone-iodine 10 % (titratable iodine 1 % ) Gel SwabstickSY11fd1661-1b8c-b65b-e063-6394a90af89b2
1300277povidone-iodine 10 % Gel SwabstickSY11fd1661-1b8c-b65b-e063-6394a90af89b2
1300277povidone-iodine 10 % SwabstickSY11fd1661-1b8c-b65b-e063-6394a90af89b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-120-0553329012005250 POUCH in 1 CASE (53329-120-05) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATOR250 pouch2024-07-01NoNoCurrent
53329-120-09533290120091 APPLICATOR in 1 POUCH (53329-120-09) / 10 mL in 1 APPLICATOR1 applicator2024-07-01NoNoCurrent
53329-120-26533290120264 POUCH in 1 BOX (53329-120-26) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATOR4 pouch2024-07-01NoNoCurrent