FDA.reportPublic FDA data

Povidone Iodine Impregnated

Product NDC
34645-4010
11-digit product format
346454010
Labeler code
34645
Product ID
34645-4010_085ba045-3c6d-fb30-e063-6394a90a3491
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine
Dosage form
SPONGE
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-01
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
Povidone Iodine Impregnated
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
14f2a1dd-92c2-49e8-9fa0-a9d88e8c530dAvailable 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
34645-4010-4Povidone Iodine Impregnated100 mL in 1 POUCHSPONGE1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE IMPREGNATED (POVIDONE IODINE) SPONGE [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]2
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE IMPREGNATED (POVIDONE IODINE) SPONGE [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-4010POVIDONE IODINE IMPREGNATED (POVIDONE IODINE) SPONGE [JIANERKANG MEDICAL CO., LTD]6Current NDC, Legacy NDC, 1 package rows20231023_14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d.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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
application number: M005
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
application number: M005
UKVOA Toenail Fungus TreatmentTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2e3cde7b-850e-f9d2-e063-6394a90adb182025-02-16WarningsExact identifier
application number: M005
UKOVA FOOT ODOR PROBIOTICTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2de0225d-dd85-e2da-e063-6294a90a050b2025-02-11WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes Foot WipesTOLNAFTATECosco International, Inc.cde656a9-7841-4a73-a2f4-f5a76a3e15c12025-02-06WarningsExact identifier
application number: M005
Silka Athletes FootMICONAZOLE NITRATEGenomma Lab USA307104a2-2df6-43b0-bf3f-f4d93d3e40f12025-02-05WarningsExact identifier
application number: M005
MICONAZOLE NitrateMICONAZOLE NITRATENuCare Pharmaceuticals,Inc.fd7dd2eb-03a7-ef1f-e053-6294a90a85572025-02-04WarningsExact identifier
application number: M005
Molecular AFTOLNAFTATERenu Laboratories, LLC1b47e687-29cf-48ce-8bc3-ac8f44f05baa2025-02-03WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Papalo Group LLC2d2c0e12-123d-75bd-e063-6394a90ae5462025-01-31WarningsExact identifier
application number: M005
70% Isopropyl AlcoholISOPROPYL ALCOHOLIDO PHARMd5833c6f-81dd-6ff6-e053-2995a90ac76d2025-01-30WarningsExact identifier
application number: M005
AWAS ALCOHOLSPRAYALCOHOLIDO PHARM03010837-0289-3e08-e063-6394a90a7d042025-01-30WarningsExact identifier
application number: M005
ELON Dual Defense Anti Fungal FormulaUNDECYLENIC ACIDLittle Giant Holdings LLC45c4567d-7876-6459-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M005
DCH Labs Antifungal JockMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCfc749882-2e1e-cad3-e053-6294a90a33ca2025-01-27WarningsExact identifier
application number: M005
Antifungal PenUNDECYLENIC ACID 25%XF Agencija Limiteda15d4512-0fc6-424f-9dd3-ab433d9b7a262025-01-27WarningsExact identifier
application number: M005
Mata HongosUNDECYLENIC ACIDVitamex USA, Corp21ca7edb-dde3-5846-e063-6394a90a3cc02025-01-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd53cb4c0d-40b5-4cf3-b122-fd6dd654883f2025-01-23WarningsExact identifier
application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGALTOLNAFTATENatureplex, LLC575b8645-9166-4242-a74f-f4aa4acaaf3d2025-01-15WarningsExact identifier
application number: M005
Tobcharm Antifungal Treatment CreamANTIFUNGAL TREATMENT CREAMGuangzhou Zanming Trading Co., Ltd.2ba241cc-2767-1190-e063-6294a90ac66b2025-01-13WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2%MICONAZOLE NITRATEAkron Pharma Inc.8933f939-098a-4257-8d9c-4d5c3240e9a62025-01-10WarningsExact identifier
application number: M005
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-4010-434645401004100 mL in 1 POUCH (34645-4010-4) 100 ml2010-01-010000-00-00NoNoCurrent