CALCAREA SILICATA- calcarea silicata 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 Silicata 6C 5gCalcarea Silicata 6C 30gCalcarea Silicata 6C 100gCalcarea Silicata 12C 5gCalcarea Silicata 12C 30gCalcarea Silicata 12C 100gCalcarea Silicata 30C 1gCalcarea Silicata 30C 5gCalcarea Silicata 30C 30gCalcarea Silicata 30C 100gCalcarea Silicata 100C 1gCalcarea Silicata 100C 5gCalcarea Silicata 100C 30gCalcarea Silicata 100C 100gCalcarea Silicata 200C 1gCalcarea Silicata 200C 5gCalcarea Silicata 200C 30gCalcarea Silicata 200C 100gCalcarea Silicata 500C 1gCalcarea Silicata 500C 5gCalcarea Silicata 500C 30gCalcarea Silicata 500C 100gCalcarea Silicata 1M 1gCalcarea Silicata 1M 5gCalcarea Silicata 1M 30gCalcarea Silicata 1M 100gCalcarea Silicata 10M 1gCalcarea Silicata 10M 5gCalcarea Silicata 10M 30gCalcarea Silicata 10M 100gCalcarea Silicata LM1 30g

CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0128
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE30 [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:37662-0128-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0128-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0128-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
4NDC:37662-0128-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE100 [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:37662-0129-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0129-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0129-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
4NDC:37662-0129-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE500 [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:37662-0131-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0131-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0131-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
4NDC:37662-0131-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE200 [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:37662-0130-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0130-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0130-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
4NDC:37662-0130-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE10 [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:37662-0133-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0133-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0133-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
4NDC:37662-0133-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0126
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE6 [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:37662-0126-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0126-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0126-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0134
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE1 [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:37662-0134-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0132
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE1 [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:37662-0132-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0132-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0132-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
4NDC:37662-0132-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
CALCAREA SILICATA 
calcarea silicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE12 [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:37662-0127-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/24/2022
2NDC:37662-0127-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
3NDC:37662-0127-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0126, 37662-0127, 37662-0128, 37662-0129, 37662-0130, 37662-0131, 37662-0132, 37662-0133, 37662-0134)

Revised: 5/2022
Document Id: dfc69349-a757-6cd9-e053-2995a90a5e51
Set id: dfc69349-a756-6cd9-e053-2995a90a5e51
Version: 1
Effective Time: 20220524
 
Hahnemann Laboratories, INC.