povidone-iodine topical antiseptic

Generic: povidone-iodine

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povidone-iodine topical antiseptic
Generic Name povidone-iodine
Labeler medline industries, lp
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 10 mg/mL

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-939
Product ID 53329-939_129c8b5c-88ca-c276-e063-6294a90a993f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2007-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329939
Hyphenated Format 53329-939

Supplemental Identifiers

RxCUI
312564
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 topical antiseptic (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (53329-939-04)
  • 473 mL in 1 BOTTLE, PLASTIC (53329-939-06)
  • 237 mL in 1 BOTTLE, PLASTIC (53329-939-08)
  • 59 mL in 1 BOTTLE, PLASTIC (53329-939-13)
  • 946 mL in 1 BOTTLE, PLASTIC (53329-939-23)
  • 3785 mL in 1 BOTTLE, PLASTIC (53329-939-25)
  • 88 mL in 1 BOTTLE, PLASTIC (53329-939-69)
source: ndc

Packages (7)

53329-939-04 118 mL in 1 BOTTLE, PLASTIC (53329-939-04) 53329-939-06 473 mL in 1 BOTTLE, PLASTIC (53329-939-06) 53329-939-08 237 mL in 1 BOTTLE, PLASTIC (53329-939-08) 53329-939-13 59 mL in 1 BOTTLE, PLASTIC (53329-939-13) 53329-939-23 946 mL in 1 BOTTLE, PLASTIC (53329-939-23) 53329-939-25 3785 mL in 1 BOTTLE, PLASTIC (53329-939-25) 53329-939-69 88 mL in 1 BOTTLE, PLASTIC (53329-939-69)

Ingredients (1)

povidone-iodine (10 mg/mL)

Linked Drug Pages (1)

Povidone-Iodine Topical Antiseptic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "129c8b5c-88ca-c276-e063-6294a90a993f", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["312564"], "spl_set_id": ["c9036a83-22f5-4a09-b01c-7093d4192c19"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (53329-939-04)", "package_ndc": "53329-939-04", "marketing_start_date": "20171027"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (53329-939-06)", "package_ndc": "53329-939-06", "marketing_start_date": "20070101"}, {"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (53329-939-08)", "package_ndc": "53329-939-08", "marketing_start_date": "20070101"}, {"sample": false, "description": "59 mL in 1 BOTTLE, PLASTIC (53329-939-13)", "package_ndc": "53329-939-13", "marketing_start_date": "20070101"}, {"sample": false, "description": "946 mL in 1 BOTTLE, PLASTIC (53329-939-23)", "package_ndc": "53329-939-23", "marketing_start_date": "20070101"}, {"sample": false, "description": "3785 mL in 1 BOTTLE, PLASTIC (53329-939-25)", "package_ndc": "53329-939-25", "marketing_start_date": "20070101"}, {"sample": false, "description": "88 mL in 1 BOTTLE, PLASTIC (53329-939-69)", "package_ndc": "53329-939-69", "marketing_start_date": "20070101"}], "brand_name": "Povidone-Iodine Topical Antiseptic", "product_id": "53329-939_129c8b5c-88ca-c276-e063-6294a90a993f", "dosage_form": "SOLUTION", "product_ndc": "53329-939", "generic_name": "Povidone-Iodine", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone-Iodine", "brand_name_suffix": "Topical Antiseptic", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "10 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20070101", "listing_expiration_date": "20261231"}