GALLIUM FLUORATUM- gallium 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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Gallium Fluoratum 6C 5gGallium Fluoratum 6C 30gGallium Fluoratum 6C 100gGallium Fluoratum 12C 5gGallium Fluoratum 12C 30gGallium Fluoratum 12C 100gGallium Fluoratum 30C 1gGallium Fluoratum 30C 5gGallium Fluoratum 30C 30gGallium Fluoratum 30C 100gGallium Fluoratum 100C 1gGallium Fluoratum 100C 5gGallium Fluoratum 100C 30gGallium Fluoratum 100C 100gGallium Fluoratum 200C 1gGallium Fluoratum 200C 5gGallium Fluoratum 200C 30gGallium Fluoratum 200C 100gGallium Fluoratum 500C 1gGallium Fluoratum 500C 5gGallium Fluoratum 500C 30gGallium Fluoratum 500C 100gGallium Fluoratum 1M 1gGallium Fluoratum 1M 5gGallium Fluoratum 1M 30gGallium Fluoratum 1M 100gGallium Fluoratum LM1 30g

GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2626
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE500 [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:37662-2626-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
2NDC:37662-2626-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
3NDC:37662-2626-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
4NDC:37662-2626-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2627
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE1 [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:37662-2627-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
2NDC:37662-2627-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
3NDC:37662-2627-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
4NDC:37662-2627-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2622
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE12 [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:37662-2622-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
2NDC:37662-2622-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
3NDC:37662-2622-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2621
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE6 [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:37662-2621-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
2NDC:37662-2621-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
3NDC:37662-2621-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2623
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE30 [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:37662-2623-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
2NDC:37662-2623-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
3NDC:37662-2623-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
4NDC:37662-2623-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2624
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE100 [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:37662-2624-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
2NDC:37662-2624-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
3NDC:37662-2624-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
4NDC:37662-2624-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2628
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE1 [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:37662-2628-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
GALLIUM FLUORATUM 
gallium fluoratum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2625
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALLIUM TRIFLUORIDE (UNII: 3EG50JLZ49) (GALLIUM TRIFLUORIDE - UNII:3EG50JLZ49) GALLIUM TRIFLUORIDE200 [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:37662-2625-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
2NDC:37662-2625-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/06/2023
3NDC:37662-2625-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
4NDC:37662-2625-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/06/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-2621, 37662-2622, 37662-2623, 37662-2624, 37662-2625, 37662-2626, 37662-2627, 37662-2628)

Revised: 2/2023
Document Id: f4133b5c-25ca-5a33-e053-2a95a90a8681
Set id: f4133b5c-25c9-5a33-e053-2a95a90a8681
Version: 1
Effective Time: 20230206
 
Hahnemann Laboratories, INC.