ROSA CANINA FLOS- rosa canina flos 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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ROSA CANINA FLOS 
rosa canina flos pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA 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:37662-3047-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3047-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3047-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3047-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
ROSA CANINA FLOS 
rosa canina flos pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA 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:37662-3050-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3050-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3050-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3050-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
ROSA CANINA FLOS 
rosa canina flos pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA 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:37662-3046-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3046-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3046-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
ROSA CANINA FLOS 
rosa canina flos pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3051
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA 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:37662-3051-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3051-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3051-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3051-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
ROSA CANINA FLOS 
rosa canina flos pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3045
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA 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:37662-3045-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3045-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3045-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
ROSA CANINA FLOS 
rosa canina flos pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3048
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA 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:37662-3048-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3048-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3048-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3048-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
ROSA CANINA FLOS 
rosa canina flos pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3049
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA 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:37662-3049-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
2NDC:37662-3049-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/27/2023
3NDC:37662-3049-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
4NDC:37662-3049-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3045, 37662-3046, 37662-3047, 37662-3048, 37662-3049, 37662-3050, 37662-3051)

Revised: 4/2023
Document Id: fa59f46b-6651-17c9-e053-6394a90ace77
Set id: fa59f46b-6650-17c9-e053-6394a90ace77
Version: 1
Effective Time: 20230427
 
Hahnemann Laboratories, INC.