GUAIACUM- guaiacum 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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Guaiacum 6C 5g Guaiacum 6C 30g Guaiacum 6C 100g Guaiacum 12C 5g Guaiacum 12C 30g Guaiacum 12C 100g Guaiacum 30C 1g Guaiacum 30C 5g Guaiacum 30C 30g Guaiacum 30C 100g Guaiacum 100C 1g Guaiacum 100C 5g Guaiacum 100C 30g Guaiacum 100C 100g Guaiacum 200C 1g Guaiacum 200C 5g Guaiacum 200C 30g Guaiacum 200C 100g Guaiacum 500C 1g Guaiacum 500C 5g Guaiacum 500C 30g Guaiacum 500C 100g Guaiacum 1M 1g Guaiacum 1M 5g Guaiacum 1M 30g Guaiacum 1M 100g

GUAIACUM
guaiacum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-1488
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	1 [hp_M]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	2mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37662-1488-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
2	NDC:37662-1488-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
3	NDC:37662-1488-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022
4	NDC:37662-1488-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/08/2022

GUAIACUM
guaiacum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-1482
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	6 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37662-1482-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
2	NDC:37662-1482-2	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022
3	NDC:37662-1482-3	4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/08/2022

GUAIACUM
guaiacum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-1483
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	12 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37662-1483-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
2	NDC:37662-1483-2	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022
3	NDC:37662-1483-3	4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/08/2022

GUAIACUM
guaiacum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-1484
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	30 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37662-1484-1	80 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
2	NDC:37662-1484-2	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
3	NDC:37662-1484-3	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022
4	NDC:37662-1484-4	4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/08/2022

GUAIACUM
guaiacum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-1485
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	100 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	2mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37662-1485-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
2	NDC:37662-1485-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
3	NDC:37662-1485-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022
4	NDC:37662-1485-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/08/2022

GUAIACUM
guaiacum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-1486
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	200 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	2mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37662-1486-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
2	NDC:37662-1486-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
3	NDC:37662-1486-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022
4	NDC:37662-1486-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/08/2022

GUAIACUM
guaiacum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-1487
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	500 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	2mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37662-1487-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
2	NDC:37662-1487-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/08/2022
3	NDC:37662-1487-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022
4	NDC:37662-1487-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/08/2022

Labeler - Hahnemann Laboratories, INC. (147098081)

Name	Address	ID/FEI	Business Operations
Establishment
Hahnemann Laboratories, INC.		147098081	manufacture(37662-1482, 37662-1483, 37662-1484, 37662-1485, 37662-1486, 37662-1487, 37662-1488)

Revised: 9/2022

Document Id: e8207fc8-0b00-430b-e053-2995a90a9610

Set id: e8207fc8-0aff-430b-e053-2995a90a9610

Version: 1

Effective Time: 20220907

Hahnemann Laboratories, INC.