ASARUM EUROPAEUM- asarum europaeum 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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Asarum Europaeum 6C 5gAsarum Europaeum 6C 30gAsarum Europaeum 6C 100gAsarum Europaeum 12C 5gAsarum Europaeum 12C 30gAsarum Europaeum 12C 100gAsarum Europaeum 30C 1gAsarum Europaeum 30C 5gAsarum Europaeum 30C 30gAsarum Europaeum 30C 100gAsarum Europaeum 100C 1gAsarum Europaeum 100C 5gAsarum Europaeum 100C 30gAsarum Europaeum 100C 100gAsarum Europaeum 200C 1gAsarum Europaeum 200C 5gAsarum Europaeum 200C 30gAsarum Europaeum 200C 100gAsarum Europaeum 500C 1gAsarum Europaeum 500C 5gAsarum Europaeum 500C 30gAsarum Europaeum 500C 100gAsarum Europaeum 1M 1gAsarum Europaeum 1M 5gAsarum Europaeum 1M 30gAsarum Europaeum 1M 100g

ASARUM EUROPAEUM 
asarum europaeum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-268
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM6 [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:63545-268-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
2NDC:63545-268-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
3NDC:63545-268-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/02/2021
ASARUM EUROPAEUM 
asarum europaeum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-269
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM12 [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:63545-269-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
2NDC:63545-269-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
3NDC:63545-269-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/02/2021
ASARUM EUROPAEUM 
asarum europaeum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-274
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM1 [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:63545-274-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
2NDC:63545-274-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
3NDC:63545-274-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
4NDC:63545-274-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/02/2021
ASARUM EUROPAEUM 
asarum europaeum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-270
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM30 [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:63545-270-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
2NDC:63545-270-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
3NDC:63545-270-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
4NDC:63545-270-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/02/2021
ASARUM EUROPAEUM 
asarum europaeum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-273
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM500 [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:63545-273-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
2NDC:63545-273-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
3NDC:63545-273-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
4NDC:63545-273-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/02/2021
ASARUM EUROPAEUM 
asarum europaeum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-271
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM100 [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:63545-271-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
2NDC:63545-271-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
3NDC:63545-271-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
4NDC:63545-271-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/02/2021
ASARUM EUROPAEUM 
asarum europaeum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-272
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM200 [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:63545-272-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
2NDC:63545-272-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
3NDC:63545-272-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
4NDC:63545-272-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/02/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Registrant - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-268, 63545-269, 63545-270, 63545-271, 63545-272, 63545-273, 63545-274)

Revised: 4/2021
Document Id: bef18dfa-8756-48eb-e053-2995a90af8da
Set id: bef18dfa-8755-48eb-e053-2995a90af8da
Version: 1
Effective Time: 20210401
 
Hahnemann Laboratories, Inc.