BISMUTHUM OXYDATUM- bismuthum 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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BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-483
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH 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:63545-483-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-483-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-483-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-484
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH 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:63545-484-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-484-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-484-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-485
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH 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:63545-485-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-485-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-485-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-485-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-486
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH 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:63545-486-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-486-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-486-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-486-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-487
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH 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:63545-487-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-487-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-487-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-487-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-488
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH 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:63545-488-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-488-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-488-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-488-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-489
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH 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:63545-489-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-489-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-489-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-489-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM OXYDATUM 
bismuthum oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-490
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE1 [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:63545-490-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-483, 63545-484, 63545-485, 63545-486, 63545-487, 63545-488, 63545-489, 63545-490)

Revised: 5/2022
Document Id: de0d2bf6-962a-7c7a-e053-2a95a90a1616
Set id: de0d2bf6-9629-7c7a-e053-2a95a90a1616
Version: 1
Effective Time: 20220502
 
Hahnemann Laboratories, INC.