MedPath

Diet Power

Drug Facts:

Approved
Approval ID

b607827c-07d1-4ec6-be94-5c25aecc12b3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

Eight and Company L.L.C

DUNS: 927364120

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Apis Mellifica, Boldo, Fucus Vesiculosus, Galium Aparine, Gambogia, Hamamelis Virginiana, Hepar Suis, Histaminum hydrochloricum, Pancreas Suis, Thuja Occidentalis

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61096-2004
Product Classification
G
Generic Name
Apis Mellifica, Boldo, Fucus Vesiculosus, Galium Aparine, Gambogia, Hamamelis Virginiana, Hepar Suis, Histaminum hydrochloricum, Pancreas Suis, Thuja Occidentalis
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (13)

PEUMUS BOLDUS LEAFActive
Quantity: 4 [hp_X] in 1 mL
Code: Q4EWM09M3O
Classification: ACTIB
FUCUS VESICULOSUSActive
Quantity: 4 [hp_X] in 1 mL
Code: 535G2ABX9M
Classification: ACTIB
GALIUM APARINE WHOLEActive
Quantity: 4 [hp_X] in 1 mL
Code: Z4B6561488
Classification: ACTIB
GAMBOGEActive
Quantity: 12 [hp_X] in 1 mL
Code: 7556HJ7587
Classification: ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKActive
Quantity: 4 [hp_X] in 1 mL
Code: T7S323PKJS
Classification: ACTIB
HISTAMINE DIHYDROCHLORIDEActive
Quantity: 200 [hp_C] in 1 mL
Code: 3POA0Q644U
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 6 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
APIS MELLIFERAActive
Quantity: 6 [hp_X] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB
PORK LIVERActive
Quantity: 12 [hp_X] in 1 mL
Code: 6EC706HI7F
Classification: ACTIB
SUS SCROFA PANCREASActive
Quantity: 12 [hp_X] in 1 mL
Code: 9Y3J3362RY
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/14/2023

PACKAGE LABEL DISPLAY:

NDC 61096-2004-1

sprayology

Diet Power

SUPPORTS WEIGHT LOSS

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

Diet Power LBL

Diet Power CNT

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/16/2021

INDICATIONS:

Temporarily relieves the common symptoms of a reducing diet, including:

° excessive appetite

° food cravings

° low energy

° water retention

° natural

° gluten & lactose free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/16/2021

OTHER INFORMATION:

Do not use if the transparent seal around spray bottle is broken or missing.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/14/2023

ACTIVE INGREDIENTS:

Apis Mellifica 6X, Boldo 4X, Fucus Vesiculosus 4X, Galium Aparine 4X, Gambogia 12X, Hamamelis Virginiana 4X, Hepar Suis 12X, Histaminum hydrochloricum 200C, Pancreas Suis 12X, Thuja Occidentalis 6X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/16/2021

PURPOSE:

Temporarily relieves the common symptoms of a reducing diet, including:

° excessive appetite
° food cravings
° low energy
° water retention

WARNINGS SECTION

LOINC: 34071-1Updated: 2/16/2021

WARNINGS:

If symptoms persist or worsen, seek advice of physician.If pregnant or breast-feeding, ask a health care professional before use.Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/16/2021

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/16/2021

DIRECTIONS:

Adults and children over 12: 2 sprays into the mouth 3 times per day 15 minutes before meals. For additional hunger control, spray 2 sprays as needed up to 6 times per day total.

Under age 12: consult a health care professional.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/16/2021

INACTIVE INGREDIENTS:

Non-GMO Glycerin, organic alcohol 20% v/v, purified water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/16/2021

QUESTIONS:

Mfd. for Eight and Company L.L.C.

Gaithersburg, MD 20879 1.800.377.5787

www.sprayology.com

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Diet Power - FDA Drug Approval Details