CHIMAPHILA UMBELLATA- chimaphila umbellata 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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CHIMAPHILA UMBELLATA 
chimaphila umbellata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-642
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA30 [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:63545-642-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-642-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-642-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-642-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CHIMAPHILA UMBELLATA 
chimaphila umbellata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-643
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA100 [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:63545-643-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-643-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-643-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-643-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CHIMAPHILA UMBELLATA 
chimaphila umbellata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-647
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA200 [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:63545-647-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-647-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-647-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-647-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CHIMAPHILA UMBELLATA 
chimaphila umbellata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-649
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA1 [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:63545-649-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-649-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-649-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-649-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CHIMAPHILA UMBELLATA 
chimaphila umbellata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-648
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA500 [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:63545-648-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-648-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-648-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-648-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CHIMAPHILA UMBELLATA 
chimaphila umbellata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-641
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA12 [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:63545-641-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-641-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-641-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CHIMAPHILA UMBELLATA 
chimaphila umbellata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA6 [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:63545-482-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-482-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-482-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-482, 63545-641, 63545-642, 63545-643, 63545-647, 63545-648, 63545-649)

Revised: 5/2022
Document Id: dec454e3-7621-04bc-e053-2995a90af264
Set id: dec454e3-7620-04bc-e053-2995a90af264
Version: 1
Effective Time: 20220511
 
Hahnemann Laboratories, INC.