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 82 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Beautifier Life Hand Sanitizer Mist OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.31628598-f7b8-111b-e063-6394a90a3de22025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.31633195-d964-278b-e063-6294a90ad42d2025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist CucumberALCOHOLShenzhen Lantern Scicence Co.,Ltd.31642cc2-c3f6-891d-e063-6294a90a28582025-03-28WarningsExact identifier
application number: M003
MeijerBENZALKONIUM CHLORIDEMeijer1e69a1b6-1b2b-8db7-e063-6294a90a78e92025-03-28WarningsExact identifier
application number: M003
Berberex Wound GelBENZETHONIUM CHLORIDE, ALLANTOINCosco International, Inc.5dd97e65-bfb3-468e-a2b1-e56d30da99df2025-03-28WarningsExact identifier
application number: M003
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.da241df2-6153-05e4-e053-2a95a90a09842025-03-26WarningsExact identifier
application number: M003
Caring Mill Hand Advanced SanitizerETHYL ALCOHOL 70%Veridian Healthcare312e0fde-8b5b-1296-e063-6294a90a4f262025-03-25WarningsExact identifier
application number: M003
HAND SANITIZING WIPESHAND SANITIZING WIPESIMAGINE AMAZON LLC30a373d6-59cd-fc74-e063-6394a90a9a9a2025-03-24WarningsExact identifier
application number: M003
Klean-Them Hand Sanitizing TowelsBENZALKONIUM CHLORIDERite-Kem, Inc.30dedeee-aadd-6436-e063-6394a90a0cde2025-03-21WarningsExact identifier
application number: M003
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEMY IMPORTS USA LLC304ab556-36d8-5fba-e063-6394a90a234a2025-03-19WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.2f03b094-c470-d0f4-e063-6394a90a47fc2025-03-19WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30997964-e81e-2159-e063-6294a90ad5dc2025-03-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.309abafa-0118-dd48-e063-6294a90a6e9f2025-03-18WarningsExact identifier
application number: M003
Smart Care Strawberry Hand Sanitizer strawberry 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3086faf2-e6e3-a7da-e063-6394a90ace542025-03-17WarningsExact identifier
application number: M003
AEROCLEANSE Instant Hand SanitizerINSTANT HAND SANITIZERAero Healthcare45aad3a4-dc7e-4b51-e054-00144ff88e882025-03-12WarningsExact identifier
application number: M003
Signature Care Instant Hand Sanitizizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.0f6a30de-4100-4673-ab9e-256bb137919b2025-03-11WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2fa8bf7a-8efc-923d-e063-6394a90a6bbb2025-03-06WarningsExact identifier
application number: M003
Jianerkang One Fluid Ounce Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd0cd2cefc-89db-49f9-b187-150c21e7f6712025-03-06WarningsExact identifier
application number: M003
XTRABENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.27df3fce-3958-d4ea-e063-6394a90a17852025-03-06WarningsExact 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