FDA.reportPublic FDA data

Medline

Product NDC
53329-232
11-digit product format
533290232
Labeler code
53329
Product ID
53329-232_4911b13a-70ff-78b2-e063-6394a90aad7a
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-30
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Medline
Listing expiration
2027-12-31

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
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48ebfdd6-d346-7e26-e063-6394a90af11aAvailable 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
53329-232-30Medline100 in 1 BOXSWAB1002
53329-232-30Medline1 in 1 PACKETSWAB12

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 45 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biopure Antibacterial Hand Wipe Berry StrawberryBENZALKONIUM CHLORIDEQuest USA Corp47d6574c-0d4c-392e-e063-6394a90a590f2026-01-07WarningsExact identifier
application number: M003
Biopure Antibacterial Hand Wipe Vallina DreamBENZALKONIUM CHLORIDEQuest USA Corp47d7090d-036b-870b-e063-6394a90a80c32026-01-07WarningsExact identifier
application number: M003
99 Plus Hand SanitizerBENZEALKONIUM CHLORIDEMomar Incorporatedf972a8f1-c928-4e4b-a8dd-a2fb77052d212026-01-06WarningsExact identifier
application number: M003
BenzocaineBENZOCAINEDynarex Corporation6161e94c-7849-466e-8da3-a6f1b085bdf92026-01-06WarningsExact identifier
application number: M003
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze ScentBENZALKONIUM CHLORIDEQuest USA Corp47c105a8-7c76-9cde-e063-6294a90a92842026-01-06WarningsExact identifier
application number: M003
SPA HAND SANITIZER VANILLAETHYL ALCOHOLRejoice International Corp.47c3c187-da54-7c3b-e063-6294a90af3ce2026-01-06WarningsExact identifier
application number: M003
SPA HAND SANITIZER CHAMPAGNE BLASHETHYL ALCOHOLRejoice International Corp.47c5e9af-4ea8-fb39-e063-6394a90aa5ab2026-01-06WarningsExact identifier
application number: M003
Antiseptic Cleaning wipeANTISEPTIC CLEANING WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD203d01ae-d99e-bce3-e063-6294a90a1a2d2026-01-05WarningsExact identifier
application number: M003
Povidone-lodine prep padPOVIDONE-LODINE PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD201545b8-0697-5601-e063-6394a90a12f42026-01-05WarningsExact identifier
application number: M003
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
application number: M003
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
application number: M003
ANTISEPTIC CLEANSING WIPE(0.9% NACL)ANTISEPTIC CLEANSING WIPE(0.9% NACL)SHENZHEN BENLIJU BIO-TECH CO.,LTD33e1c026-8a35-a47a-e063-6294a90a24062026-01-05WarningsExact identifier
application number: M003
Hand Sanitizing WipesHAND SANITIZING WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD37487da6-4e0e-6625-e063-6394a90a0af12026-01-05WarningsExact identifier
application number: M003
Hand wipesHAND WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD39f3acca-7275-88ca-e063-6394a90ad1a22026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Vanilla HeavenALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a0781b-9b25-f04b-e063-6294a90ae7e52026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a16397-dff3-7d79-e063-6394a90a040f2026-01-05WarningsExact identifier
application number: M003
IDOSWAB BISOPROPYL ALCOHOLIDO PHARM16d19630-b67a-f3e1-e063-6394a90a74292026-01-05WarningsExact identifier
application number: M003
Sure Comfort Alcohol Prep PadsISOPROPYL ALCOHOLIDO PHARM27def94b-d3a6-18b7-e063-6394a90a22a62026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Lemon LimeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeaae9-740d-a28a-e063-6294a90a64602026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeeef9-0eed-e7d0-e063-6394a90a6d312026-01-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN48ebfdd6-d346-7e26-e063-6394a90af11a2
797730povidone-iodine 100 MG/ML Medicated PadSCD48ebfdd6-d346-7e26-e063-6394a90af11a2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY48ebfdd6-d346-7e26-e063-6394a90af11a2
797730povidone-iodine 10 % Medicated PadSY48ebfdd6-d346-7e26-e063-6394a90af11a2
797730povidone-iodine 10 % Medicated SwabstickSY48ebfdd6-d346-7e26-e063-6394a90af11a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-232-3053329023230100 PACKET in 1 BOX (53329-232-30) / 1 APPLICATOR in 1 PACKET / .46 mL in 1 APPLICATOR100 packet2026-03-30NoNoCurrent