SABAL SERRULATA- sabal serrulata 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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Sabal Serrulata 6C 5gSabal Serrulata 6C 30gSabal Serrulata 6C 100gSabal Serrulata 12C 5gSabal Serrulata 12C 30gSabal Serrulata 12C 100gSabal Serrulata 30C 1gSabal Serrulata 30C 5gSabal Serrulata 30C 30gSabal Serrulata 30C 100gSabal Serrulata 100C 1gSabal Serrulata 100C 5gSabal Serrulata 100C 30gSabal Serrulata 100C 100gSabal Serrulata 200C 1gSabal Serrulata 200C 5gSabal Serrulata 200C 30gSabal Serrulata 200C 100gSabal Serrulata 500C 1gSabal Serrulata 500C 5gSabal Serrulata 500C 30gSabal Serrulata 500C 100gSabal Serrulata 1M 1gSabal Serrulata 1M 5gSabal Serrulata 1M 30gSabal Serrulata 1M 100g

SABAL SERRULATA 
sabal serrulata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1200
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO6 [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:37662-1200-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1200-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1200-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SABAL SERRULATA 
sabal serrulata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO1 [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:37662-1206-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1206-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1206-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1206-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SABAL SERRULATA 
sabal serrulata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO12 [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:37662-1201-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1201-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1201-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SABAL SERRULATA 
sabal serrulata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1203
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO100 [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:37662-1203-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1203-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1203-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1203-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SABAL SERRULATA 
sabal serrulata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO200 [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:37662-1204-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1204-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1204-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1204-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SABAL SERRULATA 
sabal serrulata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1202
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO30 [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:37662-1202-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1202-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1202-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1202-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
SABAL SERRULATA 
sabal serrulata pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1205
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO500 [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:37662-1205-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
2NDC:37662-1205-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/04/2022
3NDC:37662-1205-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
4NDC:37662-1205-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/04/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1200, 37662-1201, 37662-1202, 37662-1203, 37662-1204, 37662-1205, 37662-1206)

Revised: 8/2022
Document Id: e5718ce2-4f4f-7172-e053-2a95a90ad868
Set id: e5718ce2-4f4e-7172-e053-2a95a90ad868
Version: 1
Effective Time: 20220804
 
Hahnemann Laboratories, INC.