ARALIA QUINQUEFOLIA- aralia quinquefolia 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.

----------

Aralia Quinquefolia 6C 5gAralia Quinquefolia 6C 30gAralia Quinquefolia 6C 100gAralia Quinquefolia 12C 5gAralia Quinquefolia 12C 30gAralia Quinquefolia 12C 100g Aralia Quinquefolia 30C 1gAralia Quinquefolia 30C 5gAralia Quinquefolia 30C 30gAralia Quinquefolia 30C 100gAralia Quinquefolia 100C 1gAralia Quinquefolia 100C 5gAralia Quinquefolia 100C 30gAralia Quinquefolia 100C 100gAralia Quinquefolia 200C 1gAralia Quinquefolia 200C 5gAralia Quinquefolia 200C 30gAralia Quinquefolia 200C 100gAralia Quinquefolia 500C 1gAralia Quinquefolia 500C 5gAralia Quinquefolia 500C 30gAralia Quinquefolia 500C 100gAralia Quinquefolia 1M 1gAralia Quinquefolia 1M 5gAralia Quinquefolia 1M 30gAralia Quinquefolia 1M 100g

ARALIA QUINQUEFOLIA 
aralia quinquefolia pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-079
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG1 [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:63545-079-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-079-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-079-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-079-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2021
ARALIA QUINQUEFOLIA 
aralia quinquefolia pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-073
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG6 [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:63545-073-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-073-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-073-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2021
ARALIA QUINQUEFOLIA 
aralia quinquefolia pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-074
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG12 [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:63545-074-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-074-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-074-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2021
ARALIA QUINQUEFOLIA 
aralia quinquefolia pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-076
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG100 [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:63545-076-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-076-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-076-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-076-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2021
ARALIA QUINQUEFOLIA 
aralia quinquefolia pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-075
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG30 [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:63545-075-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-075-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-075-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-075-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2021
ARALIA QUINQUEFOLIA 
aralia quinquefolia pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-078
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG500 [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:63545-078-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-078-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-078-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-078-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2021
ARALIA QUINQUEFOLIA 
aralia quinquefolia pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-077
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG200 [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:63545-077-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-077-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-077-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-077-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Registrant - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-073, 63545-074, 63545-075, 63545-076, 63545-077, 63545-078, 63545-079)

Revised: 2/2021
Document Id: bc1a103b-b700-15f3-e053-2a95a90acfb0
Set id: bc1a103b-b6ff-15f3-e053-2a95a90acfb0
Version: 1
Effective Time: 20210224
 
Hahnemann Laboratories, Inc.