CALENDULA OFFICINALIS- calendula officinalis 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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CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0149
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [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:37662-0149-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0149-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0149-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
4NDC:37662-0149-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0151
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [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:37662-0151-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0145
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP30 [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:37662-0145-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0145-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0145-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
4NDC:37662-0145-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0146
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP100 [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:37662-0146-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0146-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0146-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
4NDC:37662-0146-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0147
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP200 [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:37662-0147-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0147-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0147-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
4NDC:37662-0147-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0148
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP500 [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:37662-0148-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0148-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0148-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
4NDC:37662-0148-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0144
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [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:37662-0144-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0144-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0144-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP10 [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:37662-0150-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0150-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0150-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
4NDC:37662-0150-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
CALENDULA OFFICINALIS 
calendula officinalis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP6 [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:37662-0143-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/25/2022
2NDC:37662-0143-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
3NDC:37662-0143-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/25/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0143, 37662-0144, 37662-0145, 37662-0146, 37662-0147, 37662-0148, 37662-0149, 37662-0150, 37662-0151)

Revised: 5/2022
Document Id: dfda3740-aa95-a083-e053-2a95a90a83a2
Set id: dfda3740-aa94-a083-e053-2a95a90a83a2
Version: 1
Effective Time: 20220525
 
Hahnemann Laboratories, INC.