HELLEBORUS NIGER- helleborus niger pellet 
Hahnemann Laboratories, INC.

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.

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HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1662
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER 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:37662-1662-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1662-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1662-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1662-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1663
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT10 [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:37662-1663-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1663-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1663-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1663-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1657
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER 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:37662-1657-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1657-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1657-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1658
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER 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:37662-1658-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1658-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1658-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1658-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1659
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER 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:37662-1659-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1659-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1659-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1659-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1660
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER 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:37662-1660-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1660-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1660-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1660-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1656
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER 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:37662-1656-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1656-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1656-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1661
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER 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:37662-1661-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1661-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1661-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1661-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
HELLEBORUS NIGER 
helleborus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1664
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT1 [hp_Q]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize1mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37662-1664-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/03/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1656, 37662-1657, 37662-1658, 37662-1659, 37662-1660, 37662-1661, 37662-1662, 37662-1663, 37662-1664)

Revised: 10/2022
Document Id: ea2b8bdf-9421-626f-e053-2a95a90a5181
Set id: ea2b8bdf-9420-626f-e053-2a95a90a5181
Version: 1
Effective Time: 20221003
 
Hahnemann Laboratories, INC.