BAPTISIA TINCTORIA- baptisia tinctoria 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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BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-356
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA 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:63545-356-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-356-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-356-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
4NDC:63545-356-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-354
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA 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:63545-354-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-354-031200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-354-044000 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
4NDC:63545-354-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-352
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA 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:63545-352-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-352-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-352-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-353
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA 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:63545-353-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-353-021200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-353-034000 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-355
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA 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:63545-355-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-355-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-355-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
4NDC:63545-355-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-358
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA 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:63545-358-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-358-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-358-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
4NDC:63545-358-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-359
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10 [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:63545-359-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-359-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-359-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
4NDC:63545-359-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
BAPTISIA TINCTORIA 
baptisia tinctoria pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-357
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA 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:63545-357-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
2NDC:63545-357-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
3NDC:63545-357-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/22/2021
4NDC:63545-357-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/22/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-352, 63545-353, 63545-354, 63545-355, 63545-356, 63545-357, 63545-358, 63545-359)

Revised: 6/2021
Document Id: c562c423-70e5-0953-e053-2a95a90a6681
Set id: c562c423-70e4-0953-e053-2a95a90a6681
Version: 1
Effective Time: 20210622
 
Hahnemann Laboratories, Inc.