povidone iodine

Generic: povidone iodine

Labeler: jianerkang medical co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povidone iodine
Generic Name povidone iodine
Labeler jianerkang medical co., ltd
Dosage Form SWAB
Routes
TOPICAL
Active Ingredients

povidone-iodine .1 mg/mL

Manufacturer
Jianerkang Medical Co., Ltd

Identifiers & Regulatory

Product NDC 34645-1043
Product ID 34645-1043_085e7fe4-e6a2-9dd9-e063-6294a90a9d87
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2015-06-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 346451043
Hyphenated Format 34645-1043

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

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 APPLICATOR in 1 POUCH (34645-1043-1) / 21 mL in 1 APPLICATOR
source: ndc

Packages (1)

34645-1043-1 1 APPLICATOR in 1 POUCH (34645-1043-1) / 21 mL in 1 APPLICATOR

Ingredients (1)

povidone-iodine (.1 mg/mL)

Linked Drug Pages (1)

Povidone Iodine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "085e7fe4-e6a2-9dd9-e063-6294a90a9d87", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "spl_set_id": ["bbe0d44d-8752-44e6-acad-f8deeebdbf17"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Jianerkang Medical Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 POUCH (34645-1043-1)  / 21 mL in 1 APPLICATOR", "package_ndc": "34645-1043-1", "marketing_start_date": "20150611"}], "brand_name": "Povidone Iodine", "product_id": "34645-1043_085e7fe4-e6a2-9dd9-e063-6294a90a9d87", "dosage_form": "SWAB", "product_ndc": "34645-1043", "generic_name": "Povidone Iodine", "labeler_name": "Jianerkang Medical Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone Iodine", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": ".1 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150611", "listing_expiration_date": "20261231"}