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 55 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Hand Sanitizer Sweet PeaALCOHOLShenzhen Lantern Scicence Co.,Ltd.435ca082-0b6b-c55e-e063-6294a90af56e2025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d514e-204a-118b-e063-6294a90aa8a62025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Spider-manALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d939c-9bef-bf86-e063-6394a90a41422025-11-11WarningsExact identifier
application number: M003
Foaming Hand SanitizerHAND SANITIZERAmerican Chemical Systems II, LLC3085d595-68b7-4100-81c0-f0699a7609d62025-11-10WarningsExact identifier
application number: M003
Genuine First Aid Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.48867a79-4d21-4ba1-9cf9-7839352a4b7e2025-11-07WarningsExact identifier
application number: M003
Pocket NurseISOPROPYL ALCOHOLPocket Nurse Enterprises, LLC42ded32e-15d9-8b03-e063-6394a90ad6bc2025-11-06WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANITIZER MIX BERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d5785f-a86b-47fb-e063-6294a90a73142025-11-05WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer Blue RaspberryALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d5afab-e872-09e3-e063-6394a90abcc42025-11-05WarningsExact identifier
application number: M003
DASIY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d632d1-17a9-b4cf-e063-6394a90a84682025-11-05WarningsExact identifier
application number: M003
DASIY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d677a4-3cc2-a039-e063-6294a90a16722025-11-05WarningsExact identifier
application number: M003
Pain Relieving CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HCLTARGET CORPORATION944b3f78-3efa-484b-84f0-00ffe95c5dfb2025-11-05WarningsExact identifier
application number: M003
Hand SanitizerSDA 40B ALCOHOL 200 PROOFTropical Seas, Inc.b48f9afa-1634-e63e-e053-2a95a90a32bf2025-11-04WarningsExact identifier
application number: M003
Smarties Orange Hand Sanitizer Raspberry CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d22dff-dca4-ead3-e063-6394a90abdce2025-11-04WarningsExact identifier
application number: M003
Smarties Hand Sanitizer Orange CreamsicleALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1fdb7-0cae-edce-e063-6294a90a9a962025-11-04WarningsExact identifier
application number: M003
MyHealth Alcohol Antiseptic Hand SanitizerALCOHOLAeroflex Industria de Aerosol Ltdaf8eeb819-ec48-41a4-920c-7cdae55d7ecd2025-10-31WarningsExact identifier
application number: M003
MyHealth Advanced Hand SanitizerALCOHOLAeroflex Industria de Aerosol Ltda0e3b2c36-57d7-438b-a2fc-fa9f00d9a5522025-10-31WarningsExact identifier
application number: M003
Nourishing Hand Sanitizer Orange CorianderALCOHOL SOLUTIONNoshinku2fed43e6-cf3a-bf33-e063-6394a90a16cf2025-10-31WarningsExact identifier
application number: M003
Coralite Antibacterial MoistBENZALKONIUM CHLORIDEUnited Exchange Corp.6245a83f-5c81-4ae6-bc6e-adfc46c370032025-10-31WarningsExact identifier
application number: M003
Castellani PaintPHENOLStratus Pharamceuticals74192c0e-3c73-4ab0-96d1-1917cbd6777a2025-10-30WarningsExact identifier
application number: M003
GrowDefender Antibacterial FoamANTIBACTERIAL FOAMGrow Defender LLC423af3d9-6413-c097-e063-6294a90ae1a92025-10-28WarningsExact 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