Label: ERDINGKELI granule

  • NDC Code(s): 84360-001-01
  • Packager: Sichuan Longlife Pharmaceutical Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 29, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ISATIS TINCTORIA ROOT 12.46%

  • PURPOSE

    Antibacterial and antiviral

  • INDICATIONS & USAGE

    Relieve symptoms caused by colds or wind chill:
    Headache

    Fever
    Nasal congestion
    Sore throat

  • WARNINGS

    Ask a doctor before use if you have

    Diabetes
    Hypertension
    Heart disease
    Kidney disease

  • DO NOT USE


    If using other medications, please consult a doctor or pharmacist before using this product.

  • WHEN USING

    When using this product

    Avoid smoking
    Avoid alcoholic drinks
    Avoid spicy food
    Use with caution for those prone to allergies


    If pregnant or breast-feeding, ask a health professional before use.

  • STOP USE


    in case of overdose, get medical help or contact a Medical Center right away

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    One bag each time, three times a day.

  • STORAGE AND HANDLING

    store at 20-25°C(68-77°F), protect from excessive moisture

  • INACTIVE INGREDIENT

    Viola yedoensis, Lobelia chinensis, Taraxacum mongolicum,with excipients of dextrin and steviosin.

  • PRINCIPAL DISPLAY PANEL

    84360-001-01

  • INGREDIENTS AND APPEARANCE
    ERDINGKELI 
    erdingkeli granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84360-001
    Route of AdministrationOROPHARYNGEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX) (ISATIS TINCTORIA ROOT - UNII:8S10GFI6DX) ISATIS TINCTORIA ROOT12.46 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TARAXACUM MONGOLICUM (UNII: 4E8QL88U6H)  
    VIOLA PHILIPPICA WHOLE (UNII: O176VC3N54)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    LOBELIA CHINENSIS TOP (UNII: ONU5W048YG)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84360-001-019 in 1 BOX05/29/2024
    14 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/29/2024
    Labeler - Sichuan Longlife Pharmaceutical Co.,Ltd (527224303)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sichuan Longlife Pharmaceutical Co.,Ltd527224303manufacture(84360-001)