FDA.reportPublic FDA data

PROHEAL POVIDONE IODINE

Product NDC
86173-004
11-digit product format
861730004
Labeler code
86173
Product ID
86173-004_5726c295-9eb8-4483-9c49-16398cd3ab35
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROHEAL POVIDONE IODINE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui312564

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

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
86173-004-218617300042112 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