HYOSCYAMUS NIGER- hyoscyamus 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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HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1687
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER1 [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:37662-1687-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1687-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1687-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
4NDC:37662-1687-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1681
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER6 [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:37662-1681-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1681-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1681-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1688
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [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:37662-1688-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1688-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1688-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
4NDC:37662-1688-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1682
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER12 [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:37662-1682-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1682-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1682-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1684
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER100 [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:37662-1684-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1684-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1684-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
4NDC:37662-1684-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1683
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER30 [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:37662-1683-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1683-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1683-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
4NDC:37662-1683-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1685
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER200 [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:37662-1685-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1685-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1685-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
4NDC:37662-1685-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
HYOSCYAMUS NIGER 
hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1686
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER500 [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:37662-1686-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
2NDC:37662-1686-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/10/2022
3NDC:37662-1686-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
4NDC:37662-1686-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1681, 37662-1682, 37662-1683, 37662-1684, 37662-1685, 37662-1686, 37662-1687, 37662-1688)

Revised: 10/2022
Document Id: eab5ec54-64ac-c7bd-e053-2995a90a5b18
Set id: eab5ec54-64ab-c7bd-e053-2995a90a5b18
Version: 1
Effective Time: 20221010
 
Hahnemann Laboratories, INC.