ARNICA MONTANA- arnica montana 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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ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-166
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [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:63545-166-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-166-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-166-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
4NDC:63545-166-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-165
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [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:63545-165-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-165-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-165-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
4NDC:63545-165-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-162
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA100 [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:63545-162-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-162-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-162-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
4NDC:63545-162-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-167
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [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:63545-167-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-159
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [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:63545-159-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-159-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-159-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA500 [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:63545-164-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-164-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-164-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
4NDC:63545-164-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [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:63545-160-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-160-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-160-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [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:63545-161-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-161-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-161-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
4NDC:63545-161-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
ARNICA MONTANA 
arnica montana pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [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:63545-163-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
2NDC:63545-163-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/12/2021
3NDC:63545-163-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
4NDC:63545-163-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/12/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Registrant - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-159, 63545-160, 63545-161, 63545-162, 63545-163, 63545-164, 63545-165, 63545-166, 63545-167)

Revised: 3/2021
Document Id: bd5fb73e-d129-1b1e-e053-2a95a90a4dea
Set id: bd5fb73e-d128-1b1e-e053-2a95a90a4dea
Version: 1
Effective Time: 20210312
 
Hahnemann Laboratories, Inc.