LITHIUM FLUORATUM- lithium 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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Lithium Fluoratum 6C 5gLithium Fluoratum 6C 30gLithium Fluoratum 6C 100gLithium Fluoratum 12C 5gLithium Fluoratum 12C 30gLithium Fluoratum 12C 100gLithium Fluoratum 30C 1gLithium Fluoratum 30C 5gLithium Fluoratum 30C 30gLithium Fluoratum 30C 100gLithium Fluoratum 100C 1gLithium Fluoratum 100C 5gLithium Fluoratum 100C 30gLithium Fluoratum 100C 100gLithium Fluoratum 200C 1gLithium Fluoratum 200C 5gLithium Fluoratum 200C 30gLithium Fluoratum 200C 100gLithium Fluoratum 500C 1gLithium Fluoratum 500C 5gLithium Fluoratum 500C 30gLithium Fluoratum 500C 100gLithium Fluoratum 1M 1gLithium Fluoratum 1M 5gLithium Fluoratum 1M 30gLithium Fluoratum 1M 100gLithium Fluoratum LM1 30g

LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3175
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3175-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
2NDC:37662-3175-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
3NDC:37662-3175-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
4NDC:37662-3175-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3178
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3178-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
2NDC:37662-3178-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
3NDC:37662-3178-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
4NDC:37662-3178-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3177
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3177-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
2NDC:37662-3177-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
3NDC:37662-3177-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
4NDC:37662-3177-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3179
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3179-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3172
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3172-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
2NDC:37662-3172-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
3NDC:37662-3172-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3173-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
2NDC:37662-3173-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
3NDC:37662-3173-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3174
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3174-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
2NDC:37662-3174-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
3NDC:37662-3174-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
4NDC:37662-3174-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
LITHIUM FLUORATUM 
lithium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3176
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LITHIUM FLUORIDE (UNII: 1485XST65B) (LITHIUM FLUORIDE - UNII:1485XST65B) LITHIUM 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:37662-3176-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
2NDC:37662-3176-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/16/2023
3NDC:37662-3176-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
4NDC:37662-3176-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/16/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3172, 37662-3173, 37662-3174, 37662-3175, 37662-3176, 37662-3177, 37662-3178, 37662-3179)

Revised: 5/2023
Document Id: fb747ef8-3ce0-317b-e053-6394a90a704a
Set id: fb747ef8-3cdf-317b-e053-6394a90a704a
Version: 1
Effective Time: 20230511
 
Hahnemann Laboratories, INC.