povidone-iodine

Generic: povidone-iodine

Labeler: mazza healthcare, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povidone-iodine
Generic Name povidone-iodine
Labeler mazza healthcare, llc
Dosage Form SWAB
Routes
TOPICAL
Active Ingredients

povidone-iodine .1 mg/mL

Manufacturer
Mazza Healthcare, LLC

Identifiers & Regulatory

Product NDC 81280-003
Product ID 81280-003_58d9f789-b981-422e-8042-16dfeea07447
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2021-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81280003
Hyphenated Format 81280-003

Supplemental Identifiers

RxCUI
1037205
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 M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 500 POUCH in 1 CARTON (81280-003-01) / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATOR
  • 500 POUCH in 1 CARTON (81280-003-03) / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATOR
source: ndc

Packages (2)

81280-003-01 500 POUCH in 1 CARTON (81280-003-01) / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATOR 81280-003-03 500 POUCH in 1 CARTON (81280-003-03) / 3 APPLICATOR in 1 POUCH / 4.5 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": "58d9f789-b981-422e-8042-16dfeea07447", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["1037205"], "spl_set_id": ["31df570a-35ae-41a2-b04a-fce65e9d596d"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Mazza Healthcare, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 POUCH in 1 CARTON (81280-003-01)  / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATOR", "package_ndc": "81280-003-01", "marketing_start_date": "20210301"}, {"sample": false, "description": "500 POUCH in 1 CARTON (81280-003-03)  / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATOR", "package_ndc": "81280-003-03", "marketing_start_date": "20210301"}], "brand_name": "Povidone-Iodine", "product_id": "81280-003_58d9f789-b981-422e-8042-16dfeea07447", "dosage_form": "SWAB", "product_ndc": "81280-003", "generic_name": "Povidone-Iodine", "labeler_name": "Mazza Healthcare, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone-Iodine", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": ".1 mg/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210301", "listing_expiration_date": "20261231"}