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  4. NDC Product Code: 48433-230 Strong Iodine Solution

NDC 48433-230 Strong Iodine Solution

Solution/ Drops Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 48433-230?
  4. Strong Iodine Solution Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
48433-230
Proprietary Name:
Strong Iodine Solution
Non-Proprietary Name: [1]
Strong Iodine Solution
Substance Name: [2]
Iodine; Potassium Iodide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Safecor Health, Llc
    Labeler Code:
    48433
    Product Label ID:
    ec12b0ab-8fee-4b4f-a6e7-349f60a6f3e0
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    09-20-2008
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 48433-230-15

    Package Description: 14 mL in 1 BOTTLE

    Product Details

    What is NDC 48433-230?

    The NDC code 48433-230 is assigned by the FDA to the product Strong Iodine Solution which is a human prescription drug product labeled by Safecor Health, Llc. The product's dosage form is solution/ drops and is administered via oral form. The product is distributed in a single package with assigned NDC code 48433-230-15 14 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Strong Iodine Solution?

    Strong Iodine Solution, containing 5 percent of iodine and 10 percent of potassium iodide, is employed in the prophylaxis of simple and colloid goiters and in the treatment of exophthalmic goiter.  It can be used alone as a preoperative preparation but is now most commonly used concomitantly with propylthiouracil and other antithyroid drugs.  When used with these drugs, Strong Iodine Solution produces involution of the hyperplastic gland thus making a less triable and vascular gland for thyroidectomy.  In addition, it has an additive antithyroid action that helps make the patient enthyroid faster than if the antithyroid drugs were used alone.

    What are Strong Iodine Solution Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • IODINE 700 mg/mL - A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically.
    • POTASSIUM IODIDE 1400 mg/mL - An inorganic compound that is used as a source of iodine in thyrotoxic crisis and in the preparation of thyrotoxic patients for thyroidectomy. (From Dorland, 27th ed)

    Which are Strong Iodine Solution UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Strong Iodine Solution Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Strong Iodine Solution?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 204913 - strong iodine (iodine 5 % / potassium iodide 10 % ) Oral Solution
    • RxCUI: 204913 - iodine 50 MG/ML / potassium iodide 100 MG/ML Oral Solution
    • RxCUI: 204913 - Iodine 50 MG/ML / K+ Iodide 100 MG/ML Oral Solution
    • RxCUI: 204913 - Iodine 50 MG/ML / Pot Iodide 100 MG/ML Oral Solution

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    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".