Label: ARALIA RACEMOSA pellet

  • NDC Code(s): 63545-080-01, 63545-080-02, 63545-080-03, 63545-081-01, view more
    63545-081-02, 63545-081-03, 63545-082-01, 63545-082-02, 63545-082-03, 63545-082-04, 63545-083-01, 63545-083-02, 63545-083-03, 63545-083-04, 63545-084-01, 63545-084-02, 63545-084-03, 63545-084-04, 63545-085-01, 63545-085-02, 63545-085-03, 63545-085-04, 63545-086-01, 63545-086-02, 63545-086-03, 63545-086-04
  • Packager: Hahnemann Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 24, 2021

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

  • ACTIVE INGREDIENT

  • DOSAGE FORMS & STRENGTHS

  • ACTIVE INGREDIENT

  • PURPOSE

  • INDICATIONS & USAGE

  • WARNINGS

  • PREGNANCY OR BREAST FEEDING

  • ASK DOCTOR

  • KEEP OUT OF REACH OF CHILDREN

  • INSTRUCTIONS FOR USE

  • DOSAGE & ADMINISTRATION

  • ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

  • INACTIVE INGREDIENT

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL

    Aralia Racemosa 6C 5gAralia Racemosa 6C 30gAralia Racemosa 6C 100gAralia Racemosa 12C 5gAralia Racemosa 12C 30gAralia Racemosa 12C 100gAralia Racemosa 30C 1gAralia Racemosa 30C 5gAralia Racemosa 30C 30gAralia Racemosa 30C 100gAralia Racemosa 100C 1gAralia Racemosa 100C 5gAralia Racemosa 100C 30gAralia Racemosa 100C 100gAralia Racemosa 200C 1gAralia Racemosa 200C 5gAralia Racemosa 200C 30gAralia Racemosa 200C 100gAralia Racemosa 500C 1gAralia Racemosa 500C 5gAralia Racemosa 500C 30gAralia Racemosa 500C 100gAralia Racemosa 1M 1gAralia Racemosa 1M 5gAralia Racemosa 1M 30gAralia Racemosa 1M 100g

  • INGREDIENTS AND APPEARANCE
    ARALIA RACEMOSA 
    aralia racemosa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT200 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-084-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    2NDC:63545-084-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    3NDC:63545-084-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    4NDC:63545-084-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2021
    ARALIA RACEMOSA 
    aralia racemosa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-085
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT500 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-085-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    2NDC:63545-085-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    3NDC:63545-085-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    4NDC:63545-085-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2021
    ARALIA RACEMOSA 
    aralia racemosa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-080-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    2NDC:63545-080-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    3NDC:63545-080-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2021
    ARALIA RACEMOSA 
    aralia racemosa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-081
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-081-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    2NDC:63545-081-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    3NDC:63545-081-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2021
    ARALIA RACEMOSA 
    aralia racemosa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-082
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-082-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    2NDC:63545-082-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    3NDC:63545-082-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    4NDC:63545-082-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2021
    ARALIA RACEMOSA 
    aralia racemosa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-083
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT100 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-083-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    2NDC:63545-083-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    3NDC:63545-083-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    4NDC:63545-083-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2021
    ARALIA RACEMOSA 
    aralia racemosa pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT1 [hp_M]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-086-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    2NDC:63545-086-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
    3NDC:63545-086-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    4NDC:63545-086-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2021
    Labeler - Hahnemann Laboratories, Inc. (147098081)
    Registrant - Hahnemann Laboratories, Inc. (147098081)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hahnemann Laboratories, Inc.147098081manufacture(63545-080, 63545-081, 63545-082, 63545-083, 63545-084, 63545-085, 63545-086)