PETROLEUM ETHERUM- petroleum etherum 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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PETROLEUM ETHERUM 
petroleum etherum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3993
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHTHA (UNII: O3L624621X) (NAPHTHA - UNII:O3L624621X) NAPHTHA12 [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:37662-3993-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
2NDC:37662-3993-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
3NDC:37662-3993-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/22/2023
PETROLEUM ETHERUM 
petroleum etherum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3994
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHTHA (UNII: O3L624621X) (NAPHTHA - UNII:O3L624621X) NAPHTHA30 [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:37662-3994-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
2NDC:37662-3994-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
3NDC:37662-3994-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
4NDC:37662-3994-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/22/2023
PETROLEUM ETHERUM 
petroleum etherum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3997
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHTHA (UNII: O3L624621X) (NAPHTHA - UNII:O3L624621X) NAPHTHA500 [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:37662-3997-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
2NDC:37662-3997-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
3NDC:37662-3997-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
4NDC:37662-3997-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/22/2023
PETROLEUM ETHERUM 
petroleum etherum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3996
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHTHA (UNII: O3L624621X) (NAPHTHA - UNII:O3L624621X) NAPHTHA200 [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:37662-3996-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
2NDC:37662-3996-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
3NDC:37662-3996-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
4NDC:37662-3996-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/22/2023
PETROLEUM ETHERUM 
petroleum etherum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3995
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHTHA (UNII: O3L624621X) (NAPHTHA - UNII:O3L624621X) NAPHTHA100 [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:37662-3995-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
2NDC:37662-3995-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
3NDC:37662-3995-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
4NDC:37662-3995-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/22/2023
PETROLEUM ETHERUM 
petroleum etherum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3998
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHTHA (UNII: O3L624621X) (NAPHTHA - UNII:O3L624621X) NAPHTHA1 [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:37662-3998-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
2NDC:37662-3998-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
3NDC:37662-3998-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
4NDC:37662-3998-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/22/2023
PETROLEUM ETHERUM 
petroleum etherum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3992
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHTHA (UNII: O3L624621X) (NAPHTHA - UNII:O3L624621X) NAPHTHA6 [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:37662-3992-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/22/2023
2NDC:37662-3992-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
3NDC:37662-3992-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/22/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3992, 37662-3993, 37662-3994, 37662-3995, 37662-3996, 37662-3997, 37662-3998)

Revised: 9/2023
Document Id: 05fb5bbf-f1c2-203d-e063-6294a90ab79e
Set id: 05fb5bbf-f1c1-203d-e063-6294a90ab79e
Version: 1
Effective Time: 20230922
 
Hahnemann Laboratories, INC.