FERRUM FLUORATUM- ferrum 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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Ferrum Fluoratum 6C 5gFerrum Fluoratum 6C 30gFerrum Fluoratum 6C 100gFerrum Fluoratum 12C 5gFerrum Fluoratum 12C 30gFerrum Fluoratum 12C 100gFerrum Fluoratum 30C 1gFerrum Fluoratum 30C 5gFerrum Fluoratum 30C 30gFerrum Fluoratum 30C 100gFerrum Fluoratum 100C 1gFerrum Fluoratum 100C 5gFerrum Fluoratum 100C 30gFerrum Fluoratum 100C 100gFerrum Fluoratum 200C 1gFerrum Fluoratum 200C 5gFerrum Fluoratum 200C 30gFerrum Fluoratum 200C 100gFerrum Fluoratum 500C 1gFerrum Fluoratum 500C 5gFerrum Fluoratum 500C 30gFerrum Fluoratum 500C 100gFerrum Fluoratum 1M 1gFerrum Fluoratum 1M 5gFerrum Fluoratum 1M 30gFerrum Fluoratum 1M 100gFerrum Fluoratum LM1 30g

FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1101-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
2NDC:37662-1101-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
3NDC:37662-1101-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1102-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
2NDC:37662-1102-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
3NDC:37662-1102-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
4NDC:37662-1102-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1106-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
2NDC:37662-1106-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
3NDC:37662-1106-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
4NDC:37662-1106-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1100-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
2NDC:37662-1100-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
3NDC:37662-1100-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1103-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
2NDC:37662-1103-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
3NDC:37662-1103-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
4NDC:37662-1103-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1104-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
2NDC:37662-1104-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
3NDC:37662-1104-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
4NDC:37662-1104-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1105-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
2NDC:37662-1105-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/29/2022
3NDC:37662-1105-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
4NDC:37662-1105-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
FERRUM FLUORATUM 
ferrum fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC FLUORIDE (UNII: 0309P36Q66) (FERRIC FLUORIDE - UNII:0309P36Q66) FERRIC 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:37662-1107-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/29/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1100, 37662-1101, 37662-1102, 37662-1103, 37662-1104, 37662-1105, 37662-1106, 37662-1107)

Revised: 7/2022
Document Id: e4f988c2-9d03-65fe-e053-2995a90aa8b4
Set id: e4f988c2-9d02-65fe-e053-2995a90aa8b4
Version: 1
Effective Time: 20220729
 
Hahnemann Laboratories, INC.