povidone iodine impregnated

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

povidone-iodine 7.5 mg/mL

Manufacturer
Jianerkang Medical Co., Ltd

Identifiers & Regulatory

Product NDC 34645-1031
Product ID 34645-1031_085eab46-3c0c-cf27-e063-6294a90a30fd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2015-03-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 346451031
Hyphenated Format 34645-1031

Supplemental Identifiers

RxCUI
1037204
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 impregnated (source: ndc)
Generic Name povidone iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 BOX (34645-1031-1) / 120 mL in 1 POUCH
source: ndc

Packages (1)

34645-1031-1 10 POUCH in 1 BOX (34645-1031-1) / 120 mL in 1 POUCH

Ingredients (1)

povidone-iodine (7.5 mg/mL)

Linked Drug Pages (1)

Povidone Iodine Impregnated ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "085eab46-3c0c-cf27-e063-6294a90a30fd", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["1037204"], "spl_set_id": ["5a33ec74-1e65-4f16-a8f7-230d7e818dbd"], "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": "10 POUCH in 1 BOX (34645-1031-1)  / 120 mL in 1 POUCH", "package_ndc": "34645-1031-1", "marketing_start_date": "20150303"}], "brand_name": "Povidone Iodine Impregnated", "product_id": "34645-1031_085eab46-3c0c-cf27-e063-6294a90a30fd", "dosage_form": "SPONGE", "product_ndc": "34645-1031", "generic_name": "Povidone Iodine", "labeler_name": "Jianerkang Medical Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone Iodine Impregnated", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "7.5 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150303", "listing_expiration_date": "20261231"}