CALCAREA BROMATA- calcarea bromata 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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Calcarea Bromata 6C 5gCalcarea Bromata 6C 30gCalcarea Bromata 6C 100gCalcarea Bromata 12C 5gCalcarea Bromata 12C 30gCalcarea Bromata 12C 100gCalcarea Bromata 30C 1gCalcarea Bromata 30C 5gCalcarea Bromata 30C 30gCalcarea Bromata 30C 100gCalcarea Bromata 100C 1gCalcarea Bromata 100C 5gCalcarea Bromata 100C 30gCalcarea Bromata 100C 100gCalcarea Bromata 200C 1gCalcarea Bromata 200C 5gCalcarea Bromata 200C 30gCalcarea Bromata 200C 100gCalcarea Bromata 500C 1g Calcarea Bromata 500C 5gCalcarea Bromata 500C 30gCalcarea Bromata 500C 100gCalcarea Bromata 1M 1gCalcarea Bromata 1M 5gCalcarea Bromata 1M 30gCalcarea Bromata 1M 100gCalcarea Bromata LM1 30g

CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0055
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE1 [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:37662-0055-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0055-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0055-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0055-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0054
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE500 [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:37662-0054-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0054-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0054-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0054-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0053
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE200 [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:37662-0053-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0053-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0053-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0053-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE1 [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:37662-0056-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0051
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE30 [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:37662-0051-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0051-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0051-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0051-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0052
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE100 [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:37662-0052-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0052-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0052-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0052-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0049
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE6 [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:37662-0049-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0049-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0049-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
CALCAREA BROMATA 
calcarea bromata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BROMATE (UNII: QJ2S78C3RO) (CALCIUM BROMATE - UNII:QJ2S78C3RO) CALCIUM BROMATE12 [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:37662-0050-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0050-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0050-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/17/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0049, 37662-0050, 37662-0051, 37662-0052, 37662-0053, 37662-0054, 37662-0055, 37662-0056)

Revised: 5/2022
Document Id: df38e786-bb21-75d6-e053-2a95a90a86c0
Set id: df38e786-bb20-75d6-e053-2a95a90a86c0
Version: 1
Effective Time: 20220517
 
Hahnemann Laboratories, INC.