povidone iodine

Generic: povidone iodine oral rinse 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 oral rinse 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 0395-9136
Product ID 0395-9136_0c93bae9-c6ed-1fc7-e063-6394a90adea9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2021-01-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03959136
Hyphenated Format 0395-9136

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 oral rinse 0.5% (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 20 mL in 1 CONTAINER (0395-9136-23)
  • 237 mL in 1 CONTAINER (0395-9136-98)
source: ndc

Packages (2)

0395-9136-23 20 mL in 1 CONTAINER (0395-9136-23) 0395-9136-98 237 mL in 1 CONTAINER (0395-9136-98)

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": "0c93bae9-c6ed-1fc7-e063-6394a90adea9", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["314935"], "spl_set_id": ["b83dbdd1-ff63-caf8-e053-2a95a90a5764"], "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": "20 mL in 1 CONTAINER (0395-9136-23)", "package_ndc": "0395-9136-23", "marketing_start_date": "20211001"}, {"sample": false, "description": "237 mL in 1 CONTAINER (0395-9136-98)", "package_ndc": "0395-9136-98", "marketing_start_date": "20210106"}], "brand_name": "Povidone Iodine", "product_id": "0395-9136_0c93bae9-c6ed-1fc7-e063-6394a90adea9", "dosage_form": "LIQUID", "product_ndc": "0395-9136", "generic_name": "Povidone Iodine Oral Rinse 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": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210106", "listing_expiration_date": "20261231"}