povidone iodine

Generic: povidone iodine gargle 0.5%

Labeler: humco holding group, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povidone iodine
Generic Name povidone iodine gargle 0.5%
Labeler humco holding group, inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

povidone-iodine 5 mg/mL

Manufacturer
Humco Holding Group, Inc.

Identifiers & Regulatory

Product NDC 0395-9128
Product ID 0395-9128_0c9380d5-c284-0902-e063-6394a90ac157
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2020-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03959128
Hyphenated Format 0395-9128

Supplemental Identifiers

RxCUI
314935
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 gargle 0.5% (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (0395-9128-98) / 237 mL in 1 CONTAINER
source: ndc

Packages (1)

0395-9128-98 1 CONTAINER in 1 CARTON (0395-9128-98) / 237 mL in 1 CONTAINER

Ingredients (1)

povidone-iodine (5 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": "0c9380d5-c284-0902-e063-6394a90ac157", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["314935"], "spl_set_id": ["a7b9ad55-cfeb-6066-e053-2a95a90af975"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Humco Holding Group, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (0395-9128-98)  / 237 mL in 1 CONTAINER", "package_ndc": "0395-9128-98", "marketing_start_date": "20200610"}], "brand_name": "Povidone Iodine", "product_id": "0395-9128_0c9380d5-c284-0902-e063-6394a90ac157", "dosage_form": "LIQUID", "product_ndc": "0395-9128", "generic_name": "Povidone Iodine Gargle 0.5%", "labeler_name": "Humco Holding Group, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone Iodine", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "5 mg/mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200610", "listing_expiration_date": "20261231"}