CALCAREA CARBONICA- calcarea carbonica 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 Carbonica 6C 5gCalcarea Carbonica 6C 30gCalcarea Carbonica 6C 100gCalcarea Carbonica 12C 5gCalcarea Carbonica 12C 30gCalcarea Carbonica 12C 100gCalcarea Carbonica 30C 1gCalcarea Carbonica 30C 5gCalcarea Carbonica 30C 30gCalcarea Carbonica 30C 100gCalcarea Carbonica 100C 1gCalcarea Carbonica 100C 5gCalcarea Carbonica 100C 30gCalcarea Carbonica 100C 100gCalcarea Carbonica 200C 1gCalcarea Carbonica 200C 5gCalcarea Carbonica 200C 30gCalcarea Carbonica 200C 100gCalcarea Carbonica 500C 1gCalcarea Carbonica 500C 5gCalcarea Carbonica 500C 30gCalcarea Carbonica 500C 100gCalcarea Carbonica 1M 1gCalcarea Carbonica 1M 5gCalcarea Carbonica 1M 30gCalcarea Carbonica 1M 100gCalcarea Carbonica 10M 1gCalcarea Carbonica 10M 5gCalcarea Carbonica 10M 30gCalcarea Carbonica 10M 100gCalcarea Carbonica LM1 30g

CALCAREA CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE6 [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:37662-0057-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0057-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0057-34000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0059
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [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:37662-0059-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0059-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0059-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0059-44000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE100 [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:37662-0060-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0060-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0060-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0060-410000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0064
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [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:37662-0064-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0064-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0064-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0064-410000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0065
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE1 [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:37662-0065-110000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE200 [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:37662-0061-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0061-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0061-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0061-410000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [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:37662-0058-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0058-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0058-34000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0062
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE500 [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:37662-0062-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0062-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0062-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0062-410000 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 CARBONICA 
calcarea carbonica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0063
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE1 [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:37662-0063-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
2NDC:37662-0063-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/17/2022
3NDC:37662-0063-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/17/2022
4NDC:37662-0063-410000 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
Labeler - Hahnemann Laboratories, INC, (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0057, 37662-0058, 37662-0059, 37662-0060, 37662-0061, 37662-0062, 37662-0063, 37662-0064, 37662-0065)

Revised: 5/2022
Document Id: df3a8618-e6bc-17f8-e053-2995a90a17db
Set id: df3a8618-e6bb-17f8-e053-2995a90a17db
Version: 1
Effective Time: 20220517
 
Hahnemann Laboratories, INC,