SAMBUCUS NIGRA- sambucus nigra 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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SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1209
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1209-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1209-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1209-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1209-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1212-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1212-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1212-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1212-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1208
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1208-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1208-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1208-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1213-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1213-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1213-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1213-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1210-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1210-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1210-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1210-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1211-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1211-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1211-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1211-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1214
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1214-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SAMBUCUS NIGRA 
sambucus nigra pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA 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:37662-1207-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1207-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1207-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1207, 37662-1208, 37662-1209, 37662-1210, 37662-1211, 37662-1212, 37662-1213, 37662-1214)

Revised: 8/2022
Document Id: e572f913-9239-d58b-e053-2995a90af6ca
Set id: e572f913-9238-d58b-e053-2995a90af6ca
Version: 1
Effective Time: 20220804
 
Hahnemann Laboratories, INC.