BORAX- borax 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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Borax 6C 5gBorax 6C 30gBorax 6C 100gBorax 12C 5gBorax 12C 30gBorax 12C 100gBorax 30C 1gBorax 30C 5gBorax 30C 30gBorax 30C 100gBorax 100C 1gBorax 100C 5gBorax 100C 30gBorax 100C 100gBorax 200C 1gBorax 200C 5gBorax 200C 30gBorax 200C 100gBorax 500C 1gBorax 500C 5gBorax 500C 30gBorax 500C 100gBorax 1M 1gBorax 1M 5gBorax 1M 30gBorax 1M 100g

BORAX 
borax pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-507
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE12 [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:63545-507-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-507-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-507-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORAX 
borax pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-506
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE6 [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:63545-506-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-506-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-506-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORAX 
borax pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-509
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE100 [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:63545-509-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-509-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-509-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-509-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORAX 
borax pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-510
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE200 [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:63545-510-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-510-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-510-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-510-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORAX 
borax pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-508
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE30 [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:63545-508-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-508-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-508-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-508-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORAX 
borax pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-511
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE500 [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:63545-511-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-511-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-511-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-511-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
BORAX 
borax pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-512
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE1 [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:63545-512-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
2NDC:63545-512-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/03/2022
3NDC:63545-512-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
4NDC:63545-512-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/03/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-506, 63545-507, 63545-508, 63545-509, 63545-510, 63545-511, 63545-512)

Revised: 5/2022
Document Id: de2165c5-02d4-77a6-e053-2995a90a46ef
Set id: de2165c5-02d3-77a6-e053-2995a90a46ef
Version: 1
Effective Time: 20220503
 
Hahnemann Laboratories, INC.