ZIRCONIUM FLUORATUM- zirconium fluoratum 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.

----------

Zirconium Fluoratum 6C 5gZirconium Fluoratum 6C 30gZirconium Fluoratum 6C 100gZirconium Fluoratum 12C 5gZirconium Fluoratum 12C 30gZirconium Fluoratum 12C 100gZirconium Fluoratum 30C 1gZirconium Fluoratum 30C 5gZirconium Fluoratum 30C 30gZirconium Fluoratum 30C 100gZirconium Fluoratum 100C 1gZirconium Fluoratum 100C 5gZirconium Fluoratum 100C 30gZirconium Fluoratum 100C 100gZirconium Fluoratum 200C 1gZirconium Fluoratum 200C 5gZirconium Fluoratum 200C 30gZirconium Fluoratum 200C 100gZirconium Fluoratum 500C 1gZirconium Fluoratum 500C 5gZirconium Fluoratum 500C 30gZirconium Fluoratum 500C 100gZirconium Fluoratum 1M 1gZirconium Fluoratum 1M 5gZirconium Fluoratum 1M 30gZirconium Fluoratum 1M 100gZirconium Fluoratum LM1 30g

ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3096
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE200 [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:37662-3096-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
2NDC:37662-3096-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
3NDC:37662-3096-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
4NDC:37662-3096-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3097
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE500 [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:37662-3097-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
2NDC:37662-3097-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
3NDC:37662-3097-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
4NDC:37662-3097-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3093
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE12 [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:37662-3093-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
2NDC:37662-3093-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
3NDC:37662-3093-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3095
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE100 [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:37662-3095-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
2NDC:37662-3095-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
3NDC:37662-3095-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
4NDC:37662-3095-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3094
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE30 [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:37662-3094-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
2NDC:37662-3094-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
3NDC:37662-3094-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
4NDC:37662-3094-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3099
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE1 [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:37662-3099-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3098
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE1 [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:37662-3098-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
2NDC:37662-3098-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
3NDC:37662-3098-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
4NDC:37662-3098-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
ZIRCONIUM FLUORATUM 
zirconium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3092
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZIRCONIUM FLUORIDE (UNII: 1XHF39056H) (ZIRCONIUM FLUORIDE - UNII:1XHF39056H) ZIRCONIUM FLUORIDE6 [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:37662-3092-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2023
2NDC:37662-3092-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
3NDC:37662-3092-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3092, 37662-3093, 37662-3094, 37662-3095, 37662-3096, 37662-3097, 37662-3098, 37662-3099)

Revised: 5/2023
Document Id: fac0d318-fd53-b2ce-e053-6394a90ad95c
Set id: fac0d318-fd52-b2ce-e053-6394a90ad95c
Version: 1
Effective Time: 20230502
 
Hahnemann Laboratories, INC.