HYDRASTIS CANADENSIS- hydrastis canadensis 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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Hydrastis Canadensis 6C 5gHydrastis Canadensis 6C 30gHydrastis Canadensis 6C 100gHydrastis Canadensis 12C 5gHydrastis Canadensis 12C 30gHydrastis Canadensis 12C 100gHydrastis Canadensis 30C 1gHydrastis Canadensis 30C 5gHydrastis Canadensis 30C 30gHydrastis Canadensis 30C 100gHydrastis Canadensis 100C 1gHydrastis Canadensis 100C 5gHydrastis Canadensis 100C 30gHydrastis Canadensis 100C 100gHydrastis Canadensis 200C 1gHydrastis Canadensis 200C 5gHydrastis Canadensis 200C 30gHydrastis Canadensis 200C 100gHydrastis Canadensis 500C 1gHydrastis Canadensis 500C 5gHydrastis Canadensis 500C 30gHydrastis Canadensis 500C 100gHydrastis Canadensis 1M 1gHydrastis Canadensis 1M 5gHydrastis Canadensis 1M 30gHydrastis Canadensis 1M 100gHydrastis Canadensis LM1 30g

HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1668
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL100 [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:37662-1668-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1668-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1668-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1668-410000 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
HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1667
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL30 [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:37662-1667-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1667-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1667-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1667-44000 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
HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1669
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL200 [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:37662-1669-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1669-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1669-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1669-410000 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
HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1672
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL1 [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:37662-1672-110000 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
HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1665
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [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:37662-1665-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1665-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1665-34000 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
HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1666
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL12 [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:37662-1666-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1666-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1666-34000 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
HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1670
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL500 [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:37662-1670-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1670-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1670-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1670-410000 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
HYDRASTIS CANADENSIS 
hydrastis canadensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1671
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL1 [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:37662-1671-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
2NDC:37662-1671-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/03/2022
3NDC:37662-1671-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/03/2022
4NDC:37662-1671-410000 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
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1665, 37662-1666, 37662-1667, 37662-1668, 37662-1669, 37662-1670, 37662-1671, 37662-1672)

Revised: 10/2022
Document Id: ea2cc59f-4490-22f8-e053-2995a90a4a30
Set id: ea2cc59f-448f-22f8-e053-2995a90a4a30
Version: 1
Effective Time: 20221003
 
Hahnemann Laboratories, INC.