FDA.reportPublic FDA data

PROHEAL POVIDONE IODINE

Product NDC
86173-004
11-digit product format
861730004
Labeler code
86173
Product ID
86173-004_8bad1602-65b8-4524-8513-95f99a9b9dec
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Click Industries LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-22
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
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
PROHEAL POVIDONE IODINE
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86173-004-04PROHEAL POVIDONE IODINE118 mL in 1 BOTTLESOLUTION1182
86173-004-08PROHEAL POVIDONE IODINE237 mL in 1 BOTTLESOLUTION2372
86173-004-21PROHEAL POVIDONE IODINE237 mL in 1 BOTTLESOLUTION2372
86173-004-21PROHEAL POVIDONE IODINE12 in 1 CASESOLUTION122
86173-004-48PROHEAL POVIDONE IODINE48 in 1 CASESOLUTION482
86173-004-48PROHEAL POVIDONE IODINE118 mL in 1 BOTTLESOLUTION1182

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 43 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
application number: M003
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
application number: M003
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d0ce42-9076-143c-e053-2995a90aeeb62026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation261c7b8f-4adc-72ec-e063-6394a90a92112026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation144453a2-8335-77be-e063-6394a90ab6762026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNc80f0a7c-c083-4199-a739-c9865c5cc1ef2
312564povidone-iodine 100 MG/ML Topical SolutionSCDc80f0a7c-c083-4199-a739-c9865c5cc1ef2
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYc80f0a7c-c083-4199-a739-c9865c5cc1ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
86173-004-0486173000404118 mL in 1 BOTTLE (86173-004-04) 118 ml2025-10-22NoNoCurrent
86173-004-0886173000408237 mL in 1 BOTTLE (86173-004-08) 237 ml2025-10-22NoNoCurrent
86173-004-1686173000416473 mL in 1 BOTTLE (86173-004-16) 473 ml2026-09-28NoNoCurrent
86173-004-218617300042112 BOTTLE in 1 CASE (86173-004-21) / 237 mL in 1 BOTTLE12 bottle2025-10-22NoNoCurrent
86173-004-488617300044848 BOTTLE in 1 CASE (86173-004-48) / 118 mL in 1 BOTTLE48 bottle2025-10-22NoNoCurrent