povidone-iodine gel

Generic: povidone-iodine

Labeler: dukal llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povidone-iodine gel
Generic Name povidone-iodine
Labeler dukal llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

povidone-iodine 1 g/100mL

Manufacturer
Dukal LLC

Identifiers & Regulatory

Product NDC 65517-0070
Product ID 65517-0070_43f8fa10-9266-a4f3-e063-6394a90a9e93
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2025-01-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 655170070
Hyphenated Format 65517-0070

Supplemental Identifiers

UNII
85H0HZU99M
NUI
N0000175486 M0011640

Packaging Origin

Original Packager
true

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 povidone-iodine gel (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 29.5 mL in 1 POUCH (65517-0070-1)
source: ndc

Packages (1)

65517-0070-1 29.5 mL in 1 POUCH (65517-0070-1)

Ingredients (1)

povidone-iodine (1 g/100mL)

Linked Drug Pages (1)

Povidone-Iodine Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "43f8fa10-9266-a4f3-e063-6394a90a9e93", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "spl_set_id": ["2bebe082-59b6-17c1-e063-6294a90a9a52"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Dukal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "29.5 mL in 1 POUCH (65517-0070-1)", "package_ndc": "65517-0070-1", "marketing_start_date": "20250121"}], "brand_name": "Povidone-Iodine Gel", "product_id": "65517-0070_43f8fa10-9266-a4f3-e063-6394a90a9e93", "dosage_form": "GEL", "product_ndc": "65517-0070", "generic_name": "Povidone-Iodine", "labeler_name": "Dukal LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone-Iodine Gel", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "1 g/100mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250121", "listing_expiration_date": "20261231"}