ARALIA RACEMOSA- aralia racemosa 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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ARALIA RACEMOSA 
aralia racemosa pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-084
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA 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:63545-084-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-084-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-084-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-084-0410000 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 RACEMOSA 
aralia racemosa pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-085
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA 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:63545-085-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-085-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-085-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-085-0410000 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 RACEMOSA 
aralia racemosa pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-080
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA 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:63545-080-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-080-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-080-034000 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 RACEMOSA 
aralia racemosa pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-081
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA 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:63545-081-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-081-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-081-034000 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 RACEMOSA 
aralia racemosa pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-082
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA 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:63545-082-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-082-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-082-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-082-044000 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 RACEMOSA 
aralia racemosa pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-083
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA 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:63545-083-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-083-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-083-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-083-0410000 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 RACEMOSA 
aralia racemosa pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA 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:63545-086-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
2NDC:63545-086-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/24/2021
3NDC:63545-086-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/24/2021
4NDC:63545-086-0410000 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
Labeler - Hahnemann Laboratories, Inc. (147098081)
Registrant - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-080, 63545-081, 63545-082, 63545-083, 63545-084, 63545-085, 63545-086)

Revised: 2/2021
Document Id: bc1c6150-aa63-f9b1-e053-2995a90a07d0
Set id: bc1c6150-aa62-f9b1-e053-2995a90a07d0
Version: 1
Effective Time: 20210224
 
Hahnemann Laboratories, Inc.