FDA.reportPublic FDA data

Humco Povidone Iodine

Product NDC
0395-2325
11-digit product format
003952325
Labeler code
0395
Product ID
0395-2325_29941ff6-7067-2a72-e063-6294a90a7f44
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine 10%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
POVIDONE-IODINE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Humco Povidone Iodine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui312564

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-2325-16Humco Povidone Iodine473 mL in 1 BOTTLE, PLASTICLIQUID4736
0395-2325-98Humco Povidone Iodine237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-2325-16ML - Milliliter0395-232539b70cc0-6fd4-47db-8915-5fae5f0c09a112013-10-17
0395-2325-98ML - Milliliter0395-232507e02985-9105-4d4e-80c2-d37b859181ee12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MHUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]1
IODINEACTIVE MOIETY9679TC07X4HUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9THUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-2325HUMCO POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]6Current NDC, Legacy NDC, 2 package rows20241220_1e078022-f32c-48bd-8add-f83aebcc5812.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN1e078022-f32c-48bd-8add-f83aebcc58126
312564povidone-iodine 100 MG/ML Topical SolutionSCD1e078022-f32c-48bd-8add-f83aebcc58126
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY1e078022-f32c-48bd-8add-f83aebcc58126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-2325-1600395232516473 mL in 1 BOTTLE, PLASTIC (0395-2325-16) 473 ml2017-11-140000-00-00NoNoCurrent
0395-2325-9800395232598237 mL in 1 BOTTLE, PLASTIC (0395-2325-98) 237 ml2017-11-140000-00-00NoNoCurrent