PHYTOLACCA DECANDRA- phytolacca decandra 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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PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1439
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1439-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
2NDC:37662-1439-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
3NDC:37662-1439-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
4NDC:37662-1439-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1435
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1435-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
2NDC:37662-1435-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
3NDC:37662-1435-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1441
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1441-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
2NDC:37662-1441-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
3NDC:37662-1441-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
4NDC:37662-1441-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1442
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1442-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1437
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1437-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
2NDC:37662-1437-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
3NDC:37662-1437-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
4NDC:37662-1437-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1436
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1436-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
2NDC:37662-1436-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
3NDC:37662-1436-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1438
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1438-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
2NDC:37662-1438-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
3NDC:37662-1438-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
4NDC:37662-1438-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
PHYTOLACCA DECANDRA 
phytolacca decandra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA 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:37662-1440-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
2NDC:37662-1440-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
3NDC:37662-1440-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/24/2022
4NDC:37662-1440-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1435, 37662-1436, 37662-1437, 37662-1438, 37662-1439, 37662-1440, 37662-1441, 37662-1442)

Revised: 8/2022
Document Id: e706a1e5-c78e-7464-e053-2995a90a35a5
Set id: e706a1e5-c78d-7464-e053-2995a90a35a5
Version: 1
Effective Time: 20220824
 
Hahnemann Laboratories, INC.