SYMPHYTUM OFFICINALE- symphytum officinale 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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SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2115
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [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:37662-2115-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2115-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2115-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT10 [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:37662-2122-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2122-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2122-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
4NDC:37662-2122-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2116
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT12 [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:37662-2116-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2116-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2116-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT30 [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:37662-2117-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2117-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2117-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
4NDC:37662-2117-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2118
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT100 [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:37662-2118-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2118-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2118-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
4NDC:37662-2118-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT500 [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:37662-2120-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2120-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2120-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
4NDC:37662-2120-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT1 [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:37662-2121-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2121-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2121-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
4NDC:37662-2121-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT1 [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:37662-2123-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
SYMPHYTUM OFFICINALE 
symphytum officinale pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2119
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT200 [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:37662-2119-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
2NDC:37662-2119-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/19/2022
3NDC:37662-2119-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
4NDC:37662-2119-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/19/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-2115, 37662-2116, 37662-2117, 37662-2118, 37662-2119, 37662-2120, 37662-2121, 37662-2122, 37662-2123)

Revised: 12/2022
Document Id: efd3ad9d-f570-914f-e053-2995a90a3ea7
Set id: efd3ad9d-f56f-914f-e053-2995a90a3ea7
Version: 1
Effective Time: 20221214
 
Hahnemann Laboratories, INC.