FDA.reportPublic FDA data

Povidone Iodine Topical Solution Paint

Product NDC
34645-1040
11-digit product format
346451040
Labeler code
34645
Product ID
34645-1040_085afb0e-73f4-114f-e063-6394a90a7fb9
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine 10%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-31
Substance
POVIDONE-IODINE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage34645-104034645-1040-1DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Topical Solution Paint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 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
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f231a572-a99d-4146-afa3-e73ea1cee027Available 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
34645-1040-1Povidone Iodine Topical Solution Paint3785 mL in 1 BOTTLELIQUID37855
34645-1040-2Povidone Iodine Topical Solution Paint59 mL in 1 BOTTLELIQUID595

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD.]1
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPOVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TPOVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-1040POVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANERKANG MEDICAL CO., LTD]5Current NDC, Legacy NDC, 2 package rows20231023_f231a572-a99d-4146-afa3-e73ea1cee027.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 112 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNf231a572-a99d-4146-afa3-e73ea1cee0275
312564povidone-iodine 100 MG/ML Topical SolutionSCDf231a572-a99d-4146-afa3-e73ea1cee0275
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYf231a572-a99d-4146-afa3-e73ea1cee0275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-1040-1346451040013785 mL in 1 BOTTLE3785 mlHistorical
34645-1040-23464510400259 mL in 1 BOTTLE (34645-1040-2) 59 ml2015-03-310000-00-00NoNoCurrent