povi-one

Generic: povidone-iodine 10% topical

Labeler: elevate oral care
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povi-one
Generic Name povidone-iodine 10% topical
Labeler elevate oral care
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

povidone-iodine 1 mg/10mL

Manufacturer
Elevate Oral Care

Identifiers & Regulatory

Product NDC 57511-0611
Product ID 57511-0611_3f28e924-0504-61d9-e063-6394a90abced
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2024-12-13

Pharmacologic Class

Established (EPC)
antiseptic [epc]
Chemical Structure
iodine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 575110611
Hyphenated Format 57511-0611

Supplemental Identifiers

UNII
85H0HZU99M
NUI
N0000175486 M0011640

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name povi-one (source: ndc)
Generic Name povidone-iodine 10% topical (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/10mL
source: ndc
Packaging
  • 8 mL in 1 BOTTLE, DISPENSING (57511-0611-2)
source: ndc

Packages (1)

57511-0611-2 8 mL in 1 BOTTLE, DISPENSING (57511-0611-2)

Ingredients (1)

povidone-iodine (1 mg/10mL)

Linked Drug Pages (2)

Povi-One ndc-match (0.9) Povi-One ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3f28e924-0504-61d9-e063-6394a90abced", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "spl_set_id": ["27c29a33-d1cc-d72f-e063-6394a90a4d45"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Elevate Oral Care"]}, "finished": true, "packaging": [{"sample": false, "description": "8 mL in 1 BOTTLE, DISPENSING (57511-0611-2)", "package_ndc": "57511-0611-2", "marketing_start_date": "20241218"}], "brand_name": "Povi-One", "product_id": "57511-0611_3f28e924-0504-61d9-e063-6394a90abced", "dosage_form": "LIQUID", "product_ndc": "57511-0611", "generic_name": "Povidone-Iodine 10% topical", "labeler_name": "Elevate Oral Care", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povi-One", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "1 mg/10mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241213", "listing_expiration_date": "20261231"}