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 111 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
application number: M003
Rite Aid Povidone IodinePOVIDONE IODINE 10%Rite Aid Corporation5df6ff37-a4ea-d666-e053-2991aa0a97862023-12-15WarningsExact identifier
application number: M003
Rite Aid Decolorized IodineETHYL ALCOHOLRite Aid Corporation5e0d3664-b02a-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M003
De La Cruz Tincture of IodineIODINE AND SODIUM IODIDE AND ALCOHOLDLC Laboratories, Inc.5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b2023-12-15WarningsExact identifier
application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIALALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0c73f4f5-2b1d-84ae-e063-6394a90a5d7b2023-12-14WarningsExact identifier
application number: M003
TaeTu AftercareBENZALKONIUM CHLORIDETaetu LLCdec15a4d-1a33-a78a-e053-2995a90a69fe2023-12-14WarningsExact identifier
application number: M003
GNP Idoinde Tincture 2% MildIODINE AND SODIUM IODIDE AND ALCOHOLAmerisource Bergen32ad75b8-abd1-4151-a035-b6c9ae5fc8882023-12-14WarningsExact identifier
application number: M003
Antibacterial Wet WipesBENZALKONIUM CHLORIDEHangZhou YangYi Daily Cosmetics Technology Co., Ltd.85d3914d-dbb8-5036-e053-2a91aa0a7cd42023-12-13WarningsExact identifier
application number: M003
AntiochPharma Rapidgel Hand SanitizerALCOHOLWeeks & Leo0c57a9ea-de66-3ced-e063-6294a90a4b8d2023-12-12WarningsExact identifier
application number: M003
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
application number: M003
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
application number: M003
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
application number: M003
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
application number: M003
Prep Pad SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd758abf53-ad8a-62ac-e053-2991aa0a8f0c2023-11-15WarningsExact identifier
application number: M003
FIRSTAR Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.49a86020-b888-423f-99a5-02fa938105ec2023-11-15WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Health4678074a-16f1-5480-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M003
Care One 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLAhold U.S.A., Inc.607b6917-2880-4b1c-83c6-f1297a828ecc2023-11-10WarningsExact identifier
application number: M003
Topcare 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDETopco Associates LLCdc4b07b6-6476-4e32-901a-da8115d6a1972023-11-10WarningsExact identifier
application number: M003
Topcare 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTopco Associates LLCbf9ee7da-69d9-47a2-8748-6b978ca3c2982023-11-10WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd40c7cfc6-ef3b-4759-b9e9-6d7e1319a8472023-11-09WarningsExact 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