povidone-iodine

Generic: povidone-iodine

Labeler: acme united corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povidone-iodine
Generic Name povidone-iodine
Labeler acme united corporation
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 10 mg/mL

Manufacturer
Acme United Corporation

Identifiers & Regulatory

Product NDC 0924-5408
Product ID 0924-5408_37c711e4-c7ae-0b71-e063-6394a90ad93e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09245408
Hyphenated Format 0924-5408

Supplemental Identifiers

RxCUI
312564
UPC
0738743100045
UNII
85H0HZU99M
NUI
N0000175486 M0011640

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 M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CONTAINER (0924-5408-01) / .6 mL in 1 VIAL, SINGLE-USE (0924-5408-00)
  • 100 VIAL, SINGLE-USE in 1 CONTAINER (0924-5408-02) / .6 mL in 1 VIAL, SINGLE-USE (0924-5408-00)
source: ndc

Packages (2)

0924-5408-01 10 VIAL, SINGLE-USE in 1 CONTAINER (0924-5408-01) / .6 mL in 1 VIAL, SINGLE-USE (0924-5408-00) 0924-5408-02 100 VIAL, SINGLE-USE in 1 CONTAINER (0924-5408-02) / .6 mL in 1 VIAL, SINGLE-USE (0924-5408-00)

Ingredients (1)

povidone-iodine (10 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": "37c711e4-c7ae-0b71-e063-6394a90ad93e", "openfda": {"nui": ["N0000175486", "M0011640"], "upc": ["0738743100045"], "unii": ["85H0HZU99M"], "rxcui": ["312564"], "spl_set_id": ["37c709ae-ef37-0b46-e063-6394a90af861"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Acme United Corporation"]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CONTAINER (0924-5408-01)  / .6 mL in 1 VIAL, SINGLE-USE (0924-5408-00)", "package_ndc": "0924-5408-01", "marketing_start_date": "20250630"}, {"sample": false, "description": "100 VIAL, SINGLE-USE in 1 CONTAINER (0924-5408-02)  / .6 mL in 1 VIAL, SINGLE-USE (0924-5408-00)", "package_ndc": "0924-5408-02", "marketing_start_date": "20250630"}], "brand_name": "POVIDONE-IODINE", "product_id": "0924-5408_37c711e4-c7ae-0b71-e063-6394a90ad93e", "dosage_form": "SOLUTION", "product_ndc": "0924-5408", "generic_name": "POVIDONE-IODINE", "labeler_name": "Acme United Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "POVIDONE-IODINE", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "10 mg/mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}