NICCOLUM CAUSTICUM- niccolum causticum 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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NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3986
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE30 [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:37662-3986-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
2NDC:37662-3986-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
3NDC:37662-3986-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
4NDC:37662-3986-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3987
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE100 [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:37662-3987-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
2NDC:37662-3987-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
3NDC:37662-3987-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
4NDC:37662-3987-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3989
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE500 [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:37662-3989-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
2NDC:37662-3989-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
3NDC:37662-3989-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
4NDC:37662-3989-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3990
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE1 [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:37662-3990-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
2NDC:37662-3990-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
3NDC:37662-3990-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
4NDC:37662-3990-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3988
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE200 [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:37662-3988-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
2NDC:37662-3988-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
3NDC:37662-3988-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
4NDC:37662-3988-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3984
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE6 [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:37662-3984-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
2NDC:37662-3984-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
3NDC:37662-3984-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3991
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE1 [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:37662-3991-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
NICCOLUM CAUSTICUM 
niccolum causticum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3985
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICKEL AMMONIUM SULFATE (UNII: 616U208TNX) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL AMMONIUM SULFATE12 [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:37662-3985-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/21/2023
2NDC:37662-3985-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
3NDC:37662-3985-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/21/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3984, 37662-3985, 37662-3986, 37662-3987, 37662-3988, 37662-3989, 37662-3990, 37662-3991)

Revised: 9/2023
Document Id: 05e8564f-05da-2880-e063-6294a90a620e
Set id: 05e8564f-05d9-2880-e063-6294a90a620e
Version: 1
Effective Time: 20230921
 
Hahnemann Laboratories, INC.