FDA.reportPublic FDA data

Povidone-Iodine

Product NDC
81280-003
11-digit product format
812800003
Labeler code
81280
Product ID
81280-003_58d9f789-b981-422e-8042-16dfeea07447
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Mazza Healthcare, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-01
Substance
POVIDONE-IODINE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Povidone-Iodine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE.1 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
1037205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31df570a-35ae-41a2-b04a-fce65e9d596dAvailable 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
81280-003-01Povidone-Iodine1 in 1 POUCHSWAB12
81280-003-01Povidone-Iodine500 in 1 CARTONSWAB5002
81280-003-03Povidone-Iodine500 in 1 CARTONSWAB5002
81280-003-03Povidone-Iodine3 in 1 POUCHSWAB32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81280-003POVIDONE-IODINE SWAB [MAZZA HEALTHCARE, LLC]2Current NDC, Legacy NDC, 4 package rows20241124_31df570a-35ae-41a2-b04a-fce65e9d596d.zip

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 18 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntifungalMICONAZOLE NITRATEAdvantice Health, LLC9a47fb1b-a41f-4c8a-8e43-7332853c308e2026-03-19WarningsExact identifier
application number: M005
AntifungalCLOTRIMAZOLEDynarex Corporation4d4cc4b4-c0b4-9e25-e063-6294a90a70b82026-03-18WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriese21ccb83-54ff-4605-80bf-7b4b789c7cb72026-03-17WarningsExact identifier
application number: M005
Peunitory Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.4d2e86bc-5122-ba4a-e063-6394a90acf132026-03-16WarningsExact identifier
application number: M005
DRMITSUI FOOT ANTIFUNGAL TREATMENTSALICYLIC ACIDZhenping Renren Industry Co., Ltd.4ce59d31-56fe-d74f-e063-6294a90a7cce2026-03-14WarningsExact identifier
application number: M005
NERANTE FUNGUS NAIL PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3984b-53cd-a665-e063-6394a90afe5f2026-03-13WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENTUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3f0e2-b532-b89f-e063-6294a90a7e252026-03-13WarningsExact identifier
application number: M005
BYT BANGYTONG HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShenzhen Jindali Technology Co., Ltd49ed1cc8-e8e5-399c-e063-6394a90a044a2026-03-10WarningsExact identifier
application number: M005
Natouch Antifungal Wipes PlusANTIFUNGAL ANTISEPTIC WIPES PLUSNatouch LLCa85cb307-b3ad-1584-e053-2995a90a9a702026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb6fdfd-116e-14e9-e063-6294a90a4de32026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b2026-03-10WarningsExact identifier
application number: M005
SootheSense Toenail Fungus TreatmentUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ca2bbeb-3b8a-9482-e063-6294a90a57892026-03-09WarningsExact identifier
application number: M005
Natouch Antifungal Antiseptic WipesANTIFUNGAL ANTISEPTIC WIPESNatouch LLC4c84c556-8d0b-ec28-e063-6294a90af1d32026-03-08WarningsExact identifier
application number: M005
ANTIFUNGAL CreamANGELICA DAHURICA EXTRACTT, ASIATIC ACIDGuangzhou Mizi Biotechnology Co., LTD.4c586cd9-d356-34d8-e063-6294a90a4d112026-03-06WarningsExact identifier
application number: M005
FungiFoamTOLNAFTATEThe Tetra Corporation2449e8e5-9d7e-4119-9e7a-378efe55f8752026-03-06WarningsExact identifier
application number: M005
RoyceDerm ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4c43e62b-9060-8962-e063-6394a90aff632026-03-05WarningsExact identifier
application number: M005
Derman AntifungalTOLNAFTATECompania Internacional de Comercio, S.A.P.I. de C.V.5784a783-1056-4d50-8d87-2df4f8e16b092026-03-05WarningsExact identifier
application number: M005
Antifungal PowderTOLNAFTATEARMY & AIR FORCE EXCHANGE SERVICE4c39e121-4919-a482-e063-6294a90a98cd2026-03-04WarningsExact identifier
application number: M005
ViLLsure Antifungal PenUNDECYLENIC ACID 25%ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD4c28cf04-94ad-8db6-e063-6394a90a2eed2026-03-03WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037205povidone-iodine 1 % Medicated PadPSN31df570a-35ae-41a2-b04a-fce65e9d596d2
1037205povidone-iodine 10 MG/ML Medicated PadSCD31df570a-35ae-41a2-b04a-fce65e9d596d2
1037205povidone-iodine 1 % Medicated PadSY31df570a-35ae-41a2-b04a-fce65e9d596d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81280-003-0181280000301500 POUCH in 1 CARTON (81280-003-01) / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATOR500 pouch2021-03-010000-00-00NoNoCurrent
81280-003-0381280000303500 POUCH in 1 CARTON (81280-003-03) / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATOR500 pouch2021-03-010000-00-00NoNoCurrent