CALCAREA IODATA- calcarea iodata 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 IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0085
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE12 [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:37662-0085-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0085-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0085-34000 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 IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0084
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE6 [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:37662-0084-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0084-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0084-34000 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 IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE30 [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:37662-0086-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0086-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0086-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0086-44000 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
CALCAREA IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0088
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE200 [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:37662-0088-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0088-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0088-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0088-410000 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 IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0090
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE1 [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:37662-0090-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0090-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0090-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0090-410000 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 IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0091
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE10 [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:37662-0091-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0091-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0091-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0091-410000 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 IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0087
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE100 [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:37662-0087-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0087-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0087-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0087-410000 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 IODATA 
calcarea iodata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0089
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE500 [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:37662-0089-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
2NDC:37662-0089-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/18/2022
3NDC:37662-0089-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2022
4NDC:37662-0089-410000 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
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0084, 37662-0085, 37662-0086, 37662-0087, 37662-0088, 37662-0089, 37662-0090, 37662-0091)

Revised: 5/2022
Document Id: df505f8d-6e8d-9621-e053-2a95a90a277f
Set id: df505f8d-6e8c-9621-e053-2a95a90a277f
Version: 1
Effective Time: 20220518
 
Hahnemann Laboratories, INC.