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 82 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
application number: M003
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
application number: M003
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
application number: M003
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
application number: M003
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
application number: M003
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsExact identifier
application number: M003
Sanitizing Hand MistETHYL ALCOHOLALO New York LLC31baefe1-2521-9ef3-e063-6294a90a450e2025-04-01WarningsExact identifier
application number: M003
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
application number: M003
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.31628598-f7b8-111b-e063-6394a90a3de22025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.31633195-d964-278b-e063-6294a90ad42d2025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist CucumberALCOHOLShenzhen Lantern Scicence Co.,Ltd.31642cc2-c3f6-891d-e063-6294a90a28582025-03-28WarningsExact identifier
application number: M003
MeijerBENZALKONIUM CHLORIDEMeijer1e69a1b6-1b2b-8db7-e063-6294a90a78e92025-03-28WarningsExact identifier
application number: M003
Berberex Wound GelBENZETHONIUM CHLORIDE, ALLANTOINCosco International, Inc.5dd97e65-bfb3-468e-a2b1-e56d30da99df2025-03-28WarningsExact identifier
application number: M003
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.da241df2-6153-05e4-e053-2a95a90a09842025-03-26WarningsExact identifier
application number: M003
Caring Mill Hand Advanced SanitizerETHYL ALCOHOL 70%Veridian Healthcare312e0fde-8b5b-1296-e063-6294a90a4f262025-03-25WarningsExact identifier
application number: M003
HAND SANITIZING WIPESHAND SANITIZING WIPESIMAGINE AMAZON LLC30a373d6-59cd-fc74-e063-6394a90a9a9a2025-03-24WarningsExact identifier
application number: M003
Klean-Them Hand Sanitizing TowelsBENZALKONIUM CHLORIDERite-Kem, Inc.30dedeee-aadd-6436-e063-6394a90a0cde2025-03-21WarningsExact identifier
application number: M003
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEMY IMPORTS USA LLC304ab556-36d8-5fba-e063-6394a90a234a2025-03-19WarningsExact 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