BORON- boron 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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Boron 6C 5gBoron 6C 30gBoron 6C 100gBoron 12c 5gBoron 12C 30gBoron 12C 100gBoron 30C 1gBoron 30C 5gBoron 30C 30gBoron 30C 100gBoron 100C 1gBoron 100C 5gBoron 100C 30gBoron 100C 100gBoron 200C 1gBoron 200C 5gBoron 200C 30gBoron 200C 100gBoron 500C 1gBoron 500C 5gBoron 500C 30gBoron 500C 100gBoron 1M 1gBoron 1M 5gBoron 1M 30gBoron 1M 100gBoron LM1 30g

BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-513
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON6 [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:63545-513-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-513-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-513-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-514
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON12 [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:63545-514-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-514-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-514-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-521
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON200 [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:63545-521-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-521-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-521-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-521-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-522
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON500 [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:63545-522-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-522-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-522-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-522-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-523
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON1 [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:63545-523-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-523-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-523-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-523-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-524
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON1 [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:63545-524-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON30 [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:63545-515-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-515-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-515-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-515-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORON 
boron pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-518
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON100 [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:63545-518-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-518-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-518-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-518-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-513, 63545-514, 63545-515, 63545-518, 63545-521, 63545-522, 63545-523, 63545-524)

Revised: 5/2022
Document Id: de22d1dc-f04f-10dd-e053-2a95a90afbef
Set id: de22d1dc-f04e-10dd-e053-2a95a90afbef
Version: 1
Effective Time: 20220503
 
Hahnemann Laboratories, INC.