CARUM CARVI- carum carvi 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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CARUM CARVI 
carum carvi pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-465
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED200 [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:63545-465-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-465-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-465-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-465-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CARUM CARVI 
carum carvi pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-462
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED12 [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:63545-462-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-462-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-462-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CARUM CARVI 
carum carvi pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-463
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED30 [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:63545-463-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-463-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-463-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-463-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CARUM CARVI 
carum carvi pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-461
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED6 [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:63545-461-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-461-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-461-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CARUM CARVI 
carum carvi pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-466
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED500 [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:63545-466-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-466-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-466-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-466-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CARUM CARVI 
carum carvi pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED1 [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:63545-467-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-467-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-467-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-467-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
CARUM CARVI 
carum carvi pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-464
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED100 [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:63545-464-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
2NDC:63545-464-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/11/2022
3NDC:63545-464-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
4NDC:63545-464-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-461, 63545-462, 63545-463, 63545-464, 63545-465, 63545-466, 63545-467)

Revised: 5/2022
Document Id: dec096db-f7bd-4b77-e053-2995a90a06a5
Set id: dec096db-f7bc-4b77-e053-2995a90a06a5
Version: 1
Effective Time: 20220511
 
Hahnemann Laboratories, INC.