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 19 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer 4pk with Glitter Silicone Case - Watermelon Splash, Mango Papaya, Pineapple Sunrise, Coconut WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.529f25f9-92eb-b7df-e063-6294a90a8dbc2026-05-25WarningsExact identifier
application number: M003
Elf Hand Sanitizer Gift Set Maple Syrup Drizzle, Peppermint Sugar Rush, Creamy Vanilla SwirlALCOHOLScent Theory Products LLC52aa188f-32b9-684a-e063-6294a90a8d4a2026-05-25WarningsExact identifier
application number: M003
Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)POVIDONE-IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD529b8ad6-081e-0ef8-e063-6294a90a67df2026-05-24WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case 2pk - Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.529bc4a4-a7e3-dbcc-e063-6294a90a7bca2026-05-24WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case 2pk - Peach BelliniALCOHOLShenzhen Lantern Scicence Co.,Ltd.529c5b79-bb85-0fb5-e063-6294a90ad8a02026-05-24WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 4pk with Silicone Case Cherry Blossom,Gardenia,Lavender Vanilla,Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.529cb9a6-3105-8a45-e063-6294a90ac5c12026-05-24WarningsExact identifier
application number: M003
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDEGLOBAL IMPORT SALES LLC30d4fa59-3b4c-a7fc-e063-6294a90aed052026-05-21WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.5251a3e8-f499-7775-e063-6294a90a44bf2026-05-21WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.51ae09af-1ce4-2831-e063-6294a90ab6a52026-05-21WarningsExact identifier
application number: M003
Walgreens 70% Isopropyl Alcohol WipesISOPROPYL ALCOHOLWalgreen Companye8b0ecc3-3a30-47c9-b7d1-518681d575b42026-05-21WarningsExact identifier
application number: M003
Scentfull Midnight Air Hand SanitizerALCOHOLScent Theory Products LLC52561c01-574a-81e8-e063-6294a90a5f822026-05-21WarningsExact identifier
application number: M003
THE WORLD OF Strawberry ShortcakeALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.52581a49-181f-7db4-e063-6394a90a46f42026-05-21WarningsExact identifier
application number: M003
First Aid Only Lidocaine Hydrochloride Analgesic Burn GelLIDOCAINE HYDROCHLORIDEAcme United Corporation5258cef2-0e5c-4ccd-e063-6394a90a9e5c2026-05-21WarningsExact identifier
application number: M003
FIGS evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLCosmetic Enterprises Ltd525c16f9-e9e0-24ab-e063-6394a90a669d2026-05-21WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.523a9ac5-3f80-ca8d-e063-6394a90ab5e72026-05-20WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.523b4aa4-e673-edb4-e063-6294a90a90542026-05-20WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss Care BearALCOHOLShenzhen Lantern Scicence Co.,Ltd.523b9b5a-30a0-1555-e063-6294a90abf912026-05-20WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Lip Gloss Polly PocketALCOHOLShenzhen Lantern Scicence Co.,Ltd.523bf360-16c7-e176-e063-6294a90a933f2026-05-20WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.523cd61a-c2ee-2c70-e063-6294a90a6c772026-05-20WarningsExact identifier
application number: M003
70% Isopropyl Alcohol70% ISOPROPYL ALCOHOLGreatdealson, Inc.4aa809cd-500a-dd65-e063-6394a90a31442026-05-20Warnings, Adverse reactionsExact 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