NDC 72988-0016 Insadol

Corn Sterilized Quantitative Extract (beta Sitosterol)

NDC Product Code 72988-0016

NDC CODE: 72988-0016

Proprietary Name: Insadol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Corn Sterilized Quantitative Extract (beta Sitosterol) 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.

Product Characteristics

ORANGE (C48331)
Shape: ROUND (C48348)
10 MM
Score: 1

NDC Code Structure

NDC 72988-0016-1

Package Description: 100 TABLET in 1 BLISTER PACK

NDC Product Information

Insadol with NDC 72988-0016 is a a human over the counter drug product labeled by Lydia Co., Ltd. The generic name of Insadol is corn sterilized quantitative extract (beta sitosterol). The product's dosage form is tablet and is administered via oral form.

Labeler Name: Lydia Co., Ltd

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

Insadol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • .BETA.-SITOSTEROL 35 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.


Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Lydia Co., Ltd
Labeler Code: 72988
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 10-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Insadol Product Label Images

Insadol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Corn sterilized quantitative extract (beta sitosterol)

Otc - Purpose

Periodontal disease [Dental caries disease, gingivitis, periodontitis (periodontal periodontitis)]

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

■ adult: two tablets once, three times a day before meal■ as a maintenance dose, one tablet once, three times a day before meal


Do not take this medicine if■ people who are hypersensitive to the drugs and ingredients contained in this medicineConsult a doctor, dentist, or pharmacist before taking this medicine■ Patients who are overreacting to substrates of azoic pigment, acetyl salicylic acid or other prostaglandin syncase inhibitors should be careful about the use of this drug ■ Be careful because this drug may interfere with the absorption of cholesterol medicines.■ Pregnancy and lactation (for pregnant women or wives who are likely to be pregnant, only if the therapeutic benefit exceeds the risk) ■ Since this drug contains yellow 4 (tartrazine), consult a doctor, dentist, or pharmacist before taking it (for that item only)Immediately stop taking this medicine and consult a doctor or pharmacist if: ■ the drug is administered to patients with asthma or chronic stomatosis or is overreacting to non-steroidal anti-inflammatory drugs, it may cause anaphylaxis or respiratory system to overreact

Inactive Ingredient

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, povidone K30

Dosage & Administration

For oral use only

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