FDA.reportPublic FDA data

Povidone Iodine Topical Solution Paint

Product NDC
34645-1041
11-digit product format
346451041
Labeler code
34645
Product ID
34645-1041_085b28a4-8daa-0685-e063-6294a90a0d08
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

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
42778607-6170-4a5e-94d0-5e6cd064eec6Available 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
34645-1041-1Povidone Iodine Topical Solution Paint88.5 mL in 1 BOTTLELIQUID88.54

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
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUPOVIDONE 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
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOVIDONE 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
34645-1041POVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 1 package rows20231023_42778607-6170-4a5e-94d0-5e6cd064eec6.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 15 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLADUSA Distribution, LLCf340dd7e-6412-4621-a818-2592ca78d0f22026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLCd95a9736-345b-4b7e-9b24-23edb3cbf7e82026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLC7e066163-6629-43ad-b0b8-09c16fe94a0d2026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.3ca0168d-8945-907a-e063-6294a90a9deb2026-06-23WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70ISOPROPYL ALCOHOLDelon Laboratories (1990) Ltd.fb481568-0c51-421f-9b73-adb4c84645aa2026-06-22WarningsExact identifier
application number: M003
Benzethonium chloride and Dyclonine hydrochlorideLIQUID BANDAGETarget Corporation326daa64-165a-cea6-e063-6294a90afbab2026-06-22WarningsExact identifier
application number: M003
MedlineISOPROPYL ALCOHOLMedline Industries, LP495076e9-3187-6bfa-e063-6394a90a01f52026-06-22WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.54def395-2f22-20a4-e063-6294a90a61962026-06-22WarningsExact identifier
application number: M003
Smart Care Hand Sanitizers 2pk Cherry Blossom and French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e431cd-98fb-8346-e063-6294a90ad85e2026-06-22WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cea78b-515c-9562-e063-6394a90af1b42026-06-21WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cecbb4-5d85-dacf-e063-6294a90af8072026-06-21WarningsExact identifier
application number: M003
Smart Care Silicone Case for Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cef14d-dd2b-905f-e063-6294a90a66ba2026-06-21WarningsExact identifier
application number: M003
Smart Care Silicone Case for Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cedd57-03a9-e5e5-e063-6394a90a486b2026-06-21WarningsExact identifier
application number: M003
Smart Care Hand Sanitizers 2pk Fresh Rain and Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cf590a-2a74-d8fe-e063-6294a90a64382026-06-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfb925-add2-f9ef-e063-6394a90a3bab2026-06-17WarningsExact identifier
application number: M003
PVP Scrub SolutionPOVIDONE IODINEMcKesson Medical-Surgical Inc.49db333e-36e1-1965-e054-00144ff8d46c2026-06-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e55a6-7d63-2344-e063-6294a90ab4c02026-06-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN42778607-6170-4a5e-94d0-5e6cd064eec64
312564povidone-iodine 100 MG/ML Topical SolutionSCD42778607-6170-4a5e-94d0-5e6cd064eec64
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY42778607-6170-4a5e-94d0-5e6cd064eec64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-1041-13464510410188.5 mL in 1 BOTTLE (34645-1041-1) 88.5 ml2015-03-310000-00-00NoNoCurrent