STRONTIUM FLUORATUM- strontium 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.

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Strontium Fluoratum 6C 5gStrontium Fluoratum 6C 30gStrontium Fluoratum 6C 100gStrontium Fluoratum 12C 5gStrontium Fluoratum 12C 30gStrontium Fluoratum 12C 100gStrontium Fluoratum 30C 1gStrontium Fluoratum 30C 5gStrontium Fluoratum 30C 30gStrontium Fluoratum 30C 100gStrontium Fluoratum 100C 1gStrontium Fluoratum 100C 5gStrontium Fluoratum 100C 30gStrontium Fluoratum 100C 100gStrontium Fluoratum 200C 1gStrontium Fluoratum 200C 5gStrontium Fluoratum 200C 30gStrontium Fluoratum 200C 100gStrontium Fluoratum 500C 1gStrontium Fluoratum 500C 5gStrontium Fluoratum 500C 30gStrontium Fluoratum 500C 100gStrontium Fluoratum 1M 1gStrontium Fluoratum 1M 5gStrontium Fluoratum 1M 30gStrontium Fluoratum 1M 100gStrontium Fluoratum LM1 30g

STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3058-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3058-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3058-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3058-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3059
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3059-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3052
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3052-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3052-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3052-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3053
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3053-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3053-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3053-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3054
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3054-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3054-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3054-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3054-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3055
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3055-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3055-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3055-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3055-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3056-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3056-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3056-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3056-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
STRONTIUM FLUORATUM 
strontium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRONTIUM FLUORIDE (UNII: EFY8GJS81Z) (STRONTIUM FLUORIDE - UNII:EFY8GJS81Z) STRONTIUM 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:37662-3057-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3057-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3057-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3057-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3052, 37662-3053, 37662-3054, 37662-3055, 37662-3056, 37662-3057, 37662-3058, 37662-3059)

Revised: 4/2023
Document Id: fa5b126b-5bc7-a682-e053-6294a90adb7f
Set id: fa5b126b-5bc6-a682-e053-6294a90adb7f
Version: 1
Effective Time: 20230427
 
Hahnemann Laboratories, INC.