DailyMed - PLEUROTUS OSTREATUS pellet

NDC Code(s): 37662-4008-1, 37662-4008-2, 37662-4008-3, 37662-4009-1, view more
37662-4009-2, 37662-4009-3, 37662-4010-1, 37662-4010-2, 37662-4010-3, 37662-4010-4, 37662-4011-1, 37662-4011-2, 37662-4011-3, 37662-4011-4, 37662-4012-1, 37662-4012-2, 37662-4012-3, 37662-4012-4, 37662-4013-1, 37662-4013-2, 37662-4013-3, 37662-4013-4, 37662-4014-1, 37662-4014-2, 37662-4014-3, 37662-4014-4
Packager: Hahnemann Laboratories, INC.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated September 25, 2023

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ACTIVE INGREDIENT

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DOSAGE FORMS & STRENGTHS

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ACTIVE INGREDIENT

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PURPOSE

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INDICATIONS & USAGE

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WARNINGS

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PREGNANCY OR BREAST FEEDING

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KEEP OUT OF REACH OF CHILDREN

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INSTRUCTIONS FOR USE

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DOSAGE & ADMINISTRATION

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ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

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INACTIVE INGREDIENT

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INGREDIENTS AND APPEARANCE

Product Information

PLEUROTUS OSTREATUS pleurotus ostreatus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-4012
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLEUROTUS OSTREATUS WHOLE (UNII: 8HZE76Y44L) (PLEUROTUS OSTREATUS WHOLE - UNII:8HZE76Y44L)	PLEUROTUS OSTREATUS WHOLE	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
Packaging
1	NDC:37662-4012-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
2	NDC:37662-4012-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
3	NDC:37662-4012-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023
4	NDC:37662-4012-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

PLEUROTUS OSTREATUS pleurotus ostreatus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-4008
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLEUROTUS OSTREATUS WHOLE (UNII: 8HZE76Y44L) (PLEUROTUS OSTREATUS WHOLE - UNII:8HZE76Y44L)	PLEUROTUS OSTREATUS WHOLE	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
Packaging
1	NDC:37662-4008-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
2	NDC:37662-4008-2	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023
3	NDC:37662-4008-3	4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

PLEUROTUS OSTREATUS pleurotus ostreatus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-4009
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLEUROTUS OSTREATUS WHOLE (UNII: 8HZE76Y44L) (PLEUROTUS OSTREATUS WHOLE - UNII:8HZE76Y44L)	PLEUROTUS OSTREATUS WHOLE	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
Packaging
1	NDC:37662-4009-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
2	NDC:37662-4009-2	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023
3	NDC:37662-4009-3	4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

PLEUROTUS OSTREATUS pleurotus ostreatus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-4011
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLEUROTUS OSTREATUS WHOLE (UNII: 8HZE76Y44L) (PLEUROTUS OSTREATUS WHOLE - UNII:8HZE76Y44L)	PLEUROTUS OSTREATUS WHOLE	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
Packaging
1	NDC:37662-4011-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
2	NDC:37662-4011-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
3	NDC:37662-4011-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023
4	NDC:37662-4011-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

PLEUROTUS OSTREATUS pleurotus ostreatus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-4014
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLEUROTUS OSTREATUS WHOLE (UNII: 8HZE76Y44L) (PLEUROTUS OSTREATUS WHOLE - UNII:8HZE76Y44L)	PLEUROTUS OSTREATUS WHOLE	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
Packaging
1	NDC:37662-4014-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
2	NDC:37662-4014-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
3	NDC:37662-4014-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023
4	NDC:37662-4014-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

PLEUROTUS OSTREATUS pleurotus ostreatus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-4010
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLEUROTUS OSTREATUS WHOLE (UNII: 8HZE76Y44L) (PLEUROTUS OSTREATUS WHOLE - UNII:8HZE76Y44L)	PLEUROTUS OSTREATUS WHOLE	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
Packaging
1	NDC:37662-4010-1	80 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
2	NDC:37662-4010-2	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
3	NDC:37662-4010-3	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023
4	NDC:37662-4010-4	4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

PLEUROTUS OSTREATUS pleurotus ostreatus pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37662-4013
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLEUROTUS OSTREATUS WHOLE (UNII: 8HZE76Y44L) (PLEUROTUS OSTREATUS WHOLE - UNII:8HZE76Y44L)	PLEUROTUS OSTREATUS WHOLE	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
Packaging
1	NDC:37662-4013-1	200 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
2	NDC:37662-4013-2	500 in 1 VIAL, GLASS; Type 0: Not a Combination Product	09/25/2023
3	NDC:37662-4013-3	3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023
4	NDC:37662-4013-4	10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

Labeler - Hahnemann Laboratories, INC. (147098081)

Name	Address	ID/FEI	Business Operations
Establishment
Hahnemann Laboratories, INC.		147098081	manufacture(37662-4008, 37662-4009, 37662-4010, 37662-4011, 37662-4012, 37662-4013, 37662-4014)

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Label: PLEUROTUS OSTREATUS pellet

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	NDC
1	37662-4008-1
2	37662-4008-2
3	37662-4008-3
4	37662-4009-1
5	37662-4009-2
6	37662-4009-3
7	37662-4010-1
8	37662-4010-2
9	37662-4010-3
10	37662-4010-4
11	37662-4011-1
12	37662-4011-2
13	37662-4011-3
14	37662-4011-4
15	37662-4012-1
16	37662-4012-2
17	37662-4012-3
18	37662-4012-4
19	37662-4013-1
20	37662-4013-2
21	37662-4013-3
22	37662-4013-4
23	37662-4014-1
24	37662-4014-2
25	37662-4014-3
26	37662-4014-4

Label: PLEUROTUS OSTREATUS pellet

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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Safety

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More Info on this Drug

PLEUROTUS OSTREATUS pellet

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PLEUROTUS OSTREATUS pellet

PLEUROTUS OSTREATUS pellet

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PLEUROTUS OSTREATUS pellet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.