FDA.reportPublic FDA data

Povidone Iodine Prep

Product NDC
60913-051
11-digit product format
609130051
Labeler code
60913
Product ID
60913-051_41d30914-6c97-01ea-e063-6394a90a9f03
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
PHOENIX HEALTHCARE SOLUTIONS, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-23
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
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 Prep
Brand name suffix
Swabstick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 g/100mL

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
8a0aba34-3f96-46b6-8521-f4388fb73edfAvailable 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
60913-051-01Povidone Iodine PrepSwabstick50 in 1 BOXSOLUTION5010
60913-051-01Povidone Iodine PrepSwabstick1 in 1 POUCHSOLUTION110
60913-051-03Povidone Iodine PrepSwabstick25 in 1 BOXSOLUTION2510
60913-051-03Povidone Iodine PrepSwabstick3 in 1 POUCHSOLUTION310

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60913-051POVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]9Current NDC, Legacy NDC, 4 package rows20241019_8a0aba34-3f96-46b6-8521-f4388fb73edf.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 32 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS0cc6b001-4982-40ee-a476-151f86c14a8e2026-02-19WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESave-A-Lot Food Stores Ltde279b23d-6779-4f04-a93c-1c2a495596392026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEMeijer, Inc.193292da-390b-4430-91b1-1d159ac505072026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMeijer, Inc.4989f1cd-4555-405a-a5f8-8714d472983c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINETarget Corporation78693ec1-d725-408c-bb95-2261faad84ac2026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Travel Wipes Fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLCea77be5e-7c69-4787-b39a-4753b002dbbd2026-02-18WarningsExact identifier
application number: M003
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
application number: M003
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS8a9848b0-19df-455a-9984-5ea2e5ce1b9f2026-02-17WarningsExact identifier
application number: M003
Wintergreen 91 - Iron LabETHYL ALCOHOLIron Lab SA de CV323a0717-0d61-c911-e063-6394a90a48542026-02-17WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
application number: M003
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
application number: M003
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
application number: M003
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
application number: M003
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnited Natural Foods, Inc. dba UNFI8a44aa29-58d6-4971-b572-4579f03ed2272026-02-17Warnings, Adverse reactionsExact identifier
application number: M003
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 100 MG/ML Medicated PadSCD8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 10 % Medicated PadSY8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 10 % Medicated SwabstickSY8a0aba34-3f96-46b6-8521-f4388fb73edf10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60913-051-016091300510150 POUCH in 1 BOX (60913-051-01) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR50 pouch2015-06-230000-00-00NoNoCurrent
60913-051-036091300510325 POUCH in 1 BOX (60913-051-03) / 3 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR25 pouch2015-06-230000-00-00NoNoCurrent