BORON OXYDATUM- boron oxydatum 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 Oxydatum 6C 5gBoron Oxydatum 6C 30gBoron Oxydatum 6C 100gBoron Oxydatum 12C 5gBoron Oxydatum 12C 30gBoron Oxydatum 12C 100gBoron Oxydatum 30C 1gBoron Oxydatum 30C 5gBoron Oxydatum 30C 30gBoron Oxydatum 30C 100gBoron Oxydatum 100C 1gBoron Oxydatum 100C 5gBoron Oxydatum 100C 30gBoron Oxydatum 100C 100gBoron Oxydatum 200C 1gBoron Oxydatum 200C 5gBoron Oxydatum 200C 30gBoron Oxydatum 200C 100gBoron Oxydatum 500C 1gBoron Oxydatum 500C 5gBoron Oxydatum 500C 30gBoron Oxydatum 500C 100gBoron Oxydatum 1M 1gBoron Oxydatum 1M 5gBoron Oxydatum 1M 30gBoron Oxydatum 1M 100gBoron Oxydatum LM1 30g

BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-525
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE6 [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:63545-525-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-525-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-525-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-526
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE12 [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:63545-526-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-526-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-526-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-527
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE30 [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:63545-527-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-527-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-527-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-527-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-528
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE100 [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:63545-528-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-528-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-528-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-528-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-529
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE200 [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:63545-529-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-529-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-529-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-529-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-530
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE500 [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:63545-530-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-530-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-530-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-530-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-531
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE1 [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:63545-531-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-531-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-531-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-531-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BORON OXYDATUM 
boron oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-532
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORON OXIDE (UNII: 483W67CPF4) (BORON OXIDE - UNII:483W67CPF4) BORON OXIDE1 [hp_Q]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize2mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63545-532-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-525, 63545-526, 63545-527, 63545-528, 63545-529, 63545-530, 63545-531, 63545-532)

Revised: 5/2022
Document Id: de342425-7b22-96a4-e053-2a95a90a4d96
Set id: de342425-7b21-96a4-e053-2a95a90a4d96
Version: 1
Effective Time: 20220504
 
Hahnemann Laboratories, INC.