DIMETHYLUM FLAVUS- dimethylum flavus 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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Dimethylum Flavus 6C 5gDimethylum Flavus 6C 30gDimethylum Flavus 6C 100gDimethylum Flavus 12C 5gDimethylum Flavus 12C 30gDimethylum Flavus 12C 100gDimethylum Flavus 30C 1gDimethylum Flavus 30C 5gDimethylum Flavus 30C 30gDimethylum Flavus 30C 100gDimethylum Flavus 100C 1gDimethylum Flavus 100C 5gDimethylum Flavus 100C 30gDimethylum Flavus 100C 100gDimethylum Flavus 200C 1gDimethylum Flavus 200C 5gDimethylum Flavus 200C 30gDimethylum Flavus 200C 100gDimethylum Flavus 500C 1gDimethylum Flavus 500C 5gDimethylum Flavus 500C 30gDimethylum Flavus 500C 100gDimethylum Flavus 1M 1gDimethylum Flavus 1M 5gDimethylum Flavus 1M 30gDimethylum Flavus 1M 100g

DIMETHYLUM FLAVUS 
dimethylum flavus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0989
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
P-DIMETHYLAMINOAZOBENZENE (UNII: A49L8E13FD) (P-DIMETHYLAMINOAZOBENZENE - UNII:A49L8E13FD) P-DIMETHYLAMINOAZOBENZENE6 [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:37662-0989-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
2NDC:37662-0989-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
3NDC:37662-0989-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/2022
DIMETHYLUM FLAVUS 
dimethylum flavus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0991
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
P-DIMETHYLAMINOAZOBENZENE (UNII: A49L8E13FD) (P-DIMETHYLAMINOAZOBENZENE - UNII:A49L8E13FD) P-DIMETHYLAMINOAZOBENZENE30 [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:37662-0991-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
2NDC:37662-0991-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
3NDC:37662-0991-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
4NDC:37662-0991-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/2022
DIMETHYLUM FLAVUS 
dimethylum flavus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0990
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
P-DIMETHYLAMINOAZOBENZENE (UNII: A49L8E13FD) (P-DIMETHYLAMINOAZOBENZENE - UNII:A49L8E13FD) P-DIMETHYLAMINOAZOBENZENE12 [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:37662-0990-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
2NDC:37662-0990-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
3NDC:37662-0990-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/2022
DIMETHYLUM FLAVUS 
dimethylum flavus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0993
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
P-DIMETHYLAMINOAZOBENZENE (UNII: A49L8E13FD) (P-DIMETHYLAMINOAZOBENZENE - UNII:A49L8E13FD) P-DIMETHYLAMINOAZOBENZENE200 [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:37662-0993-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
2NDC:37662-0993-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
3NDC:37662-0993-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
4NDC:37662-0993-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/2022
DIMETHYLUM FLAVUS 
dimethylum flavus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0995
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
P-DIMETHYLAMINOAZOBENZENE (UNII: A49L8E13FD) (P-DIMETHYLAMINOAZOBENZENE - UNII:A49L8E13FD) P-DIMETHYLAMINOAZOBENZENE1 [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:37662-0995-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
2NDC:37662-0995-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
3NDC:37662-0995-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
4NDC:37662-0995-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/2022
DIMETHYLUM FLAVUS 
dimethylum flavus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0994
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
P-DIMETHYLAMINOAZOBENZENE (UNII: A49L8E13FD) (P-DIMETHYLAMINOAZOBENZENE - UNII:A49L8E13FD) P-DIMETHYLAMINOAZOBENZENE500 [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:37662-0994-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
2NDC:37662-0994-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
3NDC:37662-0994-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
4NDC:37662-0994-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/2022
DIMETHYLUM FLAVUS 
dimethylum flavus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0992
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
P-DIMETHYLAMINOAZOBENZENE (UNII: A49L8E13FD) (P-DIMETHYLAMINOAZOBENZENE - UNII:A49L8E13FD) P-DIMETHYLAMINOAZOBENZENE100 [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:37662-0992-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
2NDC:37662-0992-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/19/2022
3NDC:37662-0992-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
4NDC:37662-0992-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0989, 37662-0990, 37662-0991, 37662-0992, 37662-0993, 37662-0994, 37662-0995)

Revised: 7/2022
Document Id: e4329129-5c5c-7f0c-e053-2995a90aa921
Set id: e4329129-5c5b-7f0c-e053-2995a90aa921
Version: 1
Effective Time: 20220719
 
Hahnemann Laboratories, INC.