CRATAEGUS- crataegus 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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Crataegus 6C 5gCrataegus 6C 30gCrataegus 6C 100gCrataegus 12C 5gCrataegus 12C 30gCrataegus 12C 100gCrataegus 30C 1gCrataegus 30C 5gCrataegus 30C 30gCrataegus 30C 100gCrataegus 100C 1gCrataegus 100C 5gCrataegus 100C 30gCrataegus 100C 100gCrataegus 200C 1gCrataegus 200C 5gCrataegus 200C 30gCrataegus 200C 100gCrataegus 500C 1gCrataegus 500C 5gCrataegus 500C 30gCrataegus 500C 100gCrataegus 1M 1gCrataegus 1M 5gCrataegus 1M 30gCrataegus 1M 100g

CRATAEGUS 
crataegus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER200 [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:37662-2210-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
2NDC:37662-2210-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
3NDC:37662-2210-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
4NDC:37662-2210-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/22/2022
CRATAEGUS 
crataegus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER500 [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:37662-2211-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
2NDC:37662-2211-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
3NDC:37662-2211-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
4NDC:37662-2211-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/22/2022
CRATAEGUS 
crataegus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER1 [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:37662-2212-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
2NDC:37662-2212-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
3NDC:37662-2212-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
4NDC:37662-2212-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/22/2022
CRATAEGUS 
crataegus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2209
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER100 [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:37662-2209-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
2NDC:37662-2209-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
3NDC:37662-2209-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
4NDC:37662-2209-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/22/2022
CRATAEGUS 
crataegus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER6 [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:37662-2206-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
2NDC:37662-2206-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
3NDC:37662-2206-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/22/2022
CRATAEGUS 
crataegus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER12 [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:37662-2207-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
2NDC:37662-2207-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
3NDC:37662-2207-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/22/2022
CRATAEGUS 
crataegus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2208
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER30 [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:37662-2208-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
2NDC:37662-2208-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product12/22/2022
3NDC:37662-2208-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
4NDC:37662-2208-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/22/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-2206, 37662-2207, 37662-2208, 37662-2209, 37662-2210, 37662-2211, 37662-2212)

Revised: 12/2022
Document Id: f0732b95-e72c-07e4-e053-2995a90a0613
Set id: f0732b95-e72b-07e4-e053-2995a90a0613
Version: 1
Effective Time: 20221222
 
Hahnemann Laboratories, INC.