FDA.reportPublic FDA data

Medline

Product NDC
53329-234
11-digit product format
533290234
Labeler code
53329
Product ID
53329-234_49de3c5a-eb56-943d-e063-6394a90ab758
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
2026-04-16
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
494d7e97-a3a8-2c7a-e063-6394a90a3ae1Available 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
53329-234-09Medline1 in 1 PACKETSWAB12
53329-234-09Medline2.06 mL in 1 APPLICATORSWAB2.062
53329-234-29Medline50 in 1 BOXSWAB502
53329-234-29Medline1 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 62 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate SwabsticksISOPROPYL ALCOHOLWalmart Inc.cd4a4490-bb02-436d-853b-f73261d358c62025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEFoodhold USA1e897ee5-17e3-459e-88e3-d7436ee22f372025-10-07WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEPremier Brands of America Inc.051b68f9-5d6c-3cd7-e063-6394a90aeb352025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEHEB40b71196-a2ac-4a44-8046-c448d066baa22025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEAmerisourceBergen Drug Corporation5c82c4db-258e-4647-aec9-1c4520e0468a2025-10-07WarningsExact identifier
application number: M003
Premier Solutions Liquid BandageBENZETHONIUM CHLORIDE DYCLONINE HYDROCHLORIDEPremier Brands of America, Inc.e196d4c2-a93e-a03c-e053-2995a90a3ea32025-10-07WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEWinCo Foods LLC15d855fe-491e-4982-e063-6394a90aea1d2025-10-07WarningsExact identifier
application number: M003
LOCKE TEDDYALCOHOL ANTISEPTICKINGKEY MBC LIFE TECHNOLOGY GROUP CO.,LTD7c0056c1-3add-49f6-8816-b61a7f5a05082025-10-07WarningsExact identifier
application number: M003
HAND SANITIZERALCHOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD66c18336-ff38-49b1-b513-2413526247472025-10-07WarningsExact identifier
application number: M003
Clean Simple Hand SanitizerALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD1524c380-9a4a-4203-9901-2731004487a02025-10-07WarningsExact identifier
application number: M003
Pure care hand sanitizerALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD26b8c4f7-6c31-42dc-8066-e733eadab1902025-10-07WarningsExact identifier
application number: M003
livWellALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD532225d0-7c9d-4043-a274-7dd7fea116622025-10-07WarningsExact identifier
application number: M003
Locke TeddyALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDfc1c8922-36a0-4150-ab32-f01f1f5466002025-10-07WarningsExact identifier
application number: M003
Anthem Hand SanitizerALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDf1755c79-bce1-4e2a-8c4c-29271581c1d02025-10-07WarningsExact identifier
application number: M003
LOCKE TEDDY Foaming Hand SanitizerBENZALKONIUM CHLORIDEKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD72bb2762-41c9-4213-9a76-4c3e9b3583832025-10-07WarningsExact identifier
application number: M003
HANDOUT protection hand sanitizerISOPROPYL ALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD098e073a-b5de-4784-8d45-59680868057f2025-10-07WarningsExact identifier
application number: M003
First Street Hand Sanitizer fresh lemonALCOHOLSMART & FINAL STORES LLC97329d42-d561-4a7d-baff-2f04b44ab0b52025-10-07WarningsExact identifier
application number: M003
povidone-iodine 10%POVIDONE-IODINEBIONPHARMA INC.3e63514a-dbb8-5bef-e063-6294a90a40082025-10-06WarningsExact identifier
application number: M003
mild iodine tinctureIODINE AND SODIUM IODIDE AND ALCOHOLBIONPHARMA INC.3ed930e0-0e73-277b-e063-6394a90a1b312025-10-06WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLFamily Dollar (FAMILY WELLNESS)abe3172e-5278-4bd0-8628-63f7b4c4e6fd2025-10-03WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN494d7e97-a3a8-2c7a-e063-6394a90a3ae12
797730povidone-iodine 100 MG/ML Medicated PadSCD494d7e97-a3a8-2c7a-e063-6394a90a3ae12
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY494d7e97-a3a8-2c7a-e063-6394a90a3ae12
797730povidone-iodine 10 % Medicated PadSY494d7e97-a3a8-2c7a-e063-6394a90a3ae12
797730povidone-iodine 10 % Medicated SwabstickSY494d7e97-a3a8-2c7a-e063-6394a90a3ae12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-234-09533290234091 APPLICATOR in 1 PACKET (53329-234-09) / 2.06 mL in 1 APPLICATOR1 applicator2026-04-16NoNoCurrent
53329-234-295332902342950 PACKET in 1 BOX (53329-234-29) / 1 APPLICATOR in 1 PACKET / 2.06 mL in 1 APPLICATOR50 packet2026-04-16NoNoCurrent