BROMIUM- bromium 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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BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-540
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE6 [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:63545-540-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-540-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-540-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-541
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE12 [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:63545-541-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-541-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-541-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-542
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE30 [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:63545-542-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-542-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-542-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-542-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-543
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE100 [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:63545-543-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-543-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-543-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-543-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-544
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE200 [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:63545-544-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-544-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-544-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-544-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-545
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE500 [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:63545-545-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-545-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-545-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-545-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-546
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE1 [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:63545-546-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
2NDC:63545-546-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/04/2022
3NDC:63545-546-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
4NDC:63545-546-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
BROMIUM 
bromium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-547
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE1 [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:63545-547-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/04/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-540, 63545-541, 63545-542, 63545-543, 63545-544, 63545-545, 63545-546, 63545-547)

Revised: 5/2022
Document Id: de3826bd-0078-0c6a-e053-2a95a90ab02d
Set id: de3826bd-0077-0c6a-e053-2a95a90ab02d
Version: 1
Effective Time: 20220504
 
Hahnemann Laboratories, INC.