BROMOETHANUM- bromoethanum 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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Bromoethanum 6C 5gBromoethanum 6C 30gBromoethanum 6C 100gBromoethanum 12C 5gBromoethanum 12C 30gBromoethanum 12C 100gBromoethanum 30C 1gBromoethanum 30C 5gBromoethanum 30C 30gBromoethanum 30C 100gBromoethanum 100C 1gBromoethanum 100C 5gBromoethanum 100C 30gBromoethanum 100C 100gBromoethanum 200C 1gBromoethanum 200C 5gBromoethanum 200C 30gBromoethanum 200C 100gBromoethanum 500C 1gBromoethanum 500C 5gBromoethanum 500C 30gBromoethanum 500C 100gBromoethanum 1M 1gBromoethanum 1M 5gBromoethanum 1M 30gBromoethanum 1M 100gBromoethanum LM1 30g

BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE12 [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:63545-327-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
2NDC:63545-327-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
3NDC:63545-327-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE500 [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:63545-331-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
2NDC:63545-331-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
3NDC:63545-331-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
4NDC:63545-331-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-333
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE1 [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:63545-333-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-328
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE30 [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:63545-328-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
2NDC:63545-328-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
3NDC:63545-328-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
4NDC:63545-328-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-329
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE100 [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:63545-329-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
2NDC:63545-329-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
3NDC:63545-329-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
4NDC:63545-329-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-326
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE6 [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:63545-326-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
2NDC:63545-326-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
3NDC:63545-326-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-330
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE200 [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:63545-330-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
2NDC:63545-330-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
3NDC:63545-330-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
4NDC:63545-330-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
BROMOETHANUM 
bromoethanum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-332
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOETHANE (UNII: LI8384T9PH) (BROMOETHANE - UNII:LI8384T9PH) BROMOETHANE1 [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:63545-332-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
2NDC:63545-332-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/10/2022
3NDC:63545-332-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
4NDC:63545-332-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/10/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-326, 63545-327, 63545-328, 63545-329, 63545-330, 63545-331, 63545-332, 63545-333)

Revised: 5/2022
Document Id: deabf506-f746-eec0-e053-2a95a90a0f62
Set id: deabf506-f745-eec0-e053-2a95a90a0f62
Version: 1
Effective Time: 20220510
 
Hahnemann Laboratories, INC.