IRIS VERSICOLOR- iris versicolor 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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Iris Versicolor 6C 5gIris Versicolor 6C 30gIris Versicolor 6C 100gIris Versicolor 12C 5gIris Versicolor 12C 30gIris Versicolor 12C 100gIris Versicolor 30C 1gIris Versicolor 30C 5gIris Versicolor 30C 30gIris Versicolor 30C 100gIris Versicolor 100C 1gIris Versicolor 100C 5gIris Versicolor 100C 30gIris Versicolor 100C 100gIris Versicolor 200C 1gIris Versicolor 200C 5gIris Versicolor 200C 30gIris Versicolor 200C 100gIris Versicolor 500C 1gIris Versicolor 500C 5gIris Versicolor 500C 30gIris Versicolor 500C 100gIris Versicolor 1M 1gIris Versicolor 1M 5gIris Versicolor 1M 30gIris Versicolor 1M 100gIris Versicolor 10M 1gIris Versicolor 10M 5gIris Versicolor 10M 30gIris Versicolor 10M 100g

IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1708
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1708-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1708-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1708-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1708-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1709
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1709-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1709-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1709-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1709-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1711
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1711-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1711-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1711-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1711-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1712
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1712-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1712-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1712-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1712-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1713
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1713-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1713-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1713-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1713-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1707
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1707-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1707-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1707-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1710
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1710-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1710-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1710-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1710-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IRIS VERSICOLOR 
iris versicolor pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1706
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR 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:37662-1706-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1706-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1706-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1706, 37662-1707, 37662-1708, 37662-1709, 37662-1710, 37662-1711, 37662-1712, 37662-1713)

Revised: 10/2022
Document Id: eadf989b-0dad-0afc-e053-2a95a90adea3
Set id: eadf989b-0dac-0afc-e053-2a95a90adea3
Version: 1
Effective Time: 20221012
 
Hahnemann Laboratories, INC.