ASAFORTIDA- asafortida 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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Asafoetida 6C 5gAsafoetida 6C 30gAsafoetida 6C 100gAsafoetida 12C 5gAsafoetida 12C 30gAsafoetida 12C 100gAsafoetida 30C 1gAsafoetida 30C 5gAsafoetida 30C 30gAsafoetida 30C 100gAsafoetida 100C 1gAsafoetida 100C 5gAsafoetida 100C 30gAsafoetida 100C 100gAsafoetida 200C 1gAsafoetida 200C 5gAsafoetida 200C 30gAsafoetida 200C 100gAsafoetida 500C 1gAsafoetida 500C 5gAsafoetida 500C 30gAsafoetida 500C 100gAsafoetida 1M 1gAsafoetida 1M 5gAsafoetida 1M 30gAsafoetida 1M 100gAsafoetida 10M 1gAsafoetida 10M 5gAsafoetida 10M 30gAsafoetida 10M 100gAsafoetida LM 1 30g

ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-264
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA1 [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:63545-264-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-264-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-264-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
4NDC:63545-264-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-267
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA12 [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:63545-267-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-267-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-267-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-260
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA30 [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:63545-260-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-260-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-260-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
4NDC:63545-260-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-262
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA200 [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:63545-262-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-262-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-262-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
4NDC:63545-262-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-261
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA100 [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:63545-261-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-261-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-261-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
4NDC:63545-261-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-257
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA6 [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:63545-257-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-257-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-257-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-263
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA500 [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:63545-263-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-263-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-263-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
4NDC:63545-263-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-266
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA1 [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:63545-266-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
ASAFORTIDA 
asafortida pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-265
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA10 [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:63545-265-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
2NDC:63545-265-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
3NDC:63545-265-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
4NDC:63545-265-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Registrant - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-257, 63545-267, 63545-260, 63545-261, 63545-262, 63545-263, 63545-264, 63545-265, 63545-266)

Revised: 4/2021
Document Id: beee19c9-1487-d594-e053-2a95a90abc4d
Set id: beee19c9-1486-d594-e053-2a95a90abc4d
Version: 1
Effective Time: 20210401
 
Hahnemann Laboratories, Inc.