CALCAREA FLUORICA- calcarea fluorica 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 Fluorica 6C 5gCalcarea Fluorica 6C 30gCalcarea Fluorica 6C 100gCalcarea Fluorica 12C 5gCalcarea Fluorica 12C 30gCalcarea Fluorica 12C 100gCalcarea Fluorica 30C 1gCalcarea Fluorica 30C 5gCalcarea Fluorica 30C 30gCalcarea Fluorica 30C 100gCalcarea Fluorica 100C 1gCalcarea Fluorica 100C 5gCalcarea Fluorica 100C 30gCalcarea Fluorica 100C 100gCalcarea Fluorica 200C 1g Calcarea Fluorica 200C 5gCalcarea Fluorica 200C 30gCalcarea Fluorica 200C 100gCalcarea Fluorica 500C 1g Calcarea Fluorica 500C 5gCalcarea Fluorica 500C 30gCalcarea Fluorica 500C 100gCalcarea Fluorica 1M 1gCalcarea Fluorica 1M 5gCalcarea Fluorica 1M 30gCalcarea Fluorica 1M 100gCalcarea Fluorica 10M 1gCalcarea Fluorica 10M 5gCalcarea Fluorica 10M 30gCalcarea Fluorica 10M 100gCalcarea Fluorica LM1 30g

CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0081
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE1 [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:37662-0081-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0081-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0081-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0081-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0082
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE10 [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:37662-0082-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0082-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0082-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0082-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0083
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE1 [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:37662-0083-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0075
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [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:37662-0075-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0075-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0075-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0079
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE200 [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:37662-0079-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0079-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0079-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0079-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0076
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [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:37662-0076-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0076-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0076-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0078
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE100 [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:37662-0078-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0078-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0078-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0078-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0080
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE500 [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:37662-0080-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0080-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0080-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0080-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
CALCAREA FLUORICA 
calcarea fluorica pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0077
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [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:37662-0077-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0077-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0077-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0077-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/18/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0075, 37662-0076, 37662-0077, 37662-0078, 37662-0079, 37662-0080, 37662-0081, 37662-0082, 37662-0083)

Revised: 5/2022
Document Id: df4d09a9-a719-510c-e053-2995a90a3d6b
Set id: df4d09a9-a718-510c-e053-2995a90a3d6b
Version: 1
Effective Time: 20220518
 
Hahnemann Laboratories, INC.