ACTAEA SPICATA- actaea spicata 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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ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3456
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3456-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3456-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3456-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3459
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3459-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3459-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3459-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3459-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3461
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3461-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3461-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3461-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3461-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3460
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3460-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3460-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3460-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3460-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3463
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3463-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3463-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3463-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3463-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3462
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3462-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3462-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3462-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3462-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3458
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3458-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3458-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3458-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3458-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
ACTAEA SPICATA 
actaea spicata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3457
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA 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:37662-3457-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3457-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3457-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3457, 37662-3456, 37662-3458, 37662-3459, 37662-3460, 37662-3461, 37662-3462, 37662-3463)

Revised: 6/2023
Document Id: ff3d269e-a041-2ffa-e053-6294a90a4089
Set id: ff3d269e-a040-2ffa-e053-6294a90a4089
Version: 1
Effective Time: 20230628
 
Hahnemann Laboratories, INC.