NDC 72988-0022 Ssanggi Tang

Ssanghwa Extract

NDC Product Code 72988-0022

NDC 72988-0022-1

Package Description: 80 mL in 1 POUCH

NDC Product Information

Ssanggi Tang with NDC 72988-0022 is a a human over the counter drug product labeled by Lydia Co., Ltd. The generic name of Ssanggi Tang is ssanghwa extract. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Lydia Co., Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Ssanggi Tang 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.

  • PAEONIA LACTIFLORA ROOT .9785 g/100mL
  • REHMANNIA GLUTINOSA ROOT .6745 g/100mL
  • LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT .627 g/100mL
  • ASTRAGALUS GUMMIFER ROOT .4845 g/100mL

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.

  • FRUCTOSE (UNII: 6YSS42VSEV)
  • WATER (UNII: 059QF0KO0R)

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’.

* Please review the disclaimer below.

Ssanggi Tang Product Label Images

Ssanggi Tang 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

Ssanghwa extract (peony root, rehmannia root, cnidium rhizome, astragalus root, angelica gias root, cinnamon bark, licorice, raw ginger, jujube)

Otc - Purpose

For cure fatigue, physical weakness, and illness such as cold sweats

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Take 1 pouch 3 times a day

Warnings

Do not intake if the product is found to have expired or corruptedwhen using this product be aware that the contents may flow when openingstop use and ask a doctor if you have certain body types and allergies, it can cause a severe allergic reaction

Inactive Ingredient

Water, liquid fructose

Dosage & Administration

For oral use only

* Please review the disclaimer below.