F22 Somatica

Agrimony, Calochortus Tolmiei, Cimicifuga Racemosa, Clematis Vitalba, Dandelion, Diplacus Aurantiacus, Echinacea Angustifolia, Ehrendorferia Chrysantha, Fuchsia, Hydrastis Canadensis, Kali Phosphoricum, Larix Decidua, Lathyrus Odoratus, Lonicera Caprifolium, Natrum Muriaticum, Rosa Californica, Rosmarinus Officinalis, Stigmata Maidis, Sulphur, Yarrow, Yerba Santa


Apex Energetics Inc.
Human Otc Drug
NDC 63479-0622
F22 Somatica also known as Agrimony, Calochortus Tolmiei, Cimicifuga Racemosa, Clematis Vitalba, Dandelion, Diplacus Aurantiacus, Echinacea Angustifolia, Ehrendorferia Chrysantha, Fuchsia, Hydrastis Canadensis, Kali Phosphoricum, Larix Decidua, Lathyrus Odoratus, Lonicera Caprifolium, Natrum Muriaticum, Rosa Californica, Rosmarinus Officinalis, Stigmata Maidis, Sulphur, Yarrow, Yerba Santa is a human otc drug labeled by 'Apex Energetics Inc.'. National Drug Code (NDC) number for F22 Somatica is 63479-0622. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in F22 Somatica drug includes Achillea Millefolium Flower - 12 [hp_C]/mL Agrimonia Eupatoria Flower - 12 [hp_C]/mL Black Cohosh - 15 [hp_C]/mL Calochortus Tolmiei Whole - 12 [hp_C]/mL Clematis Vitalba Flower - 12 [hp_C]/mL Corn Silk - 12 [hp_C]/mL Diplacus Aurantiacus Whole - 12 [hp_C]/mL Echinacea Angustifolia - 9 [hp_X]/mL Ehrendorferia Chrysantha Whole - 12 [hp_C]/mL Eriodictyon Californicum Flowering Top - 12 [hp_C]/mL and more. The currest status of F22 Somatica drug is Active.

Drug Information:

Drug NDC: 63479-0622
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: F22 Somatica
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: F22
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: SOMATICA
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Agrimony, Calochortus Tolmiei, Cimicifuga Racemosa, Clematis Vitalba, Dandelion, Diplacus Aurantiacus, Echinacea Angustifolia, Ehrendorferia Chrysantha, Fuchsia, Hydrastis Canadensis, Kali Phosphoricum, Larix Decidua, Lathyrus Odoratus, Lonicera Caprifolium, Natrum Muriaticum, Rosa Californica, Rosmarinus Officinalis, Stigmata Maidis, Sulphur, Yarrow, Yerba Santa
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Apex Energetics Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ACHILLEA MILLEFOLIUM FLOWER - 12 [hp_C]/mL
AGRIMONIA EUPATORIA FLOWER - 12 [hp_C]/mL
BLACK COHOSH - 15 [hp_C]/mL
CALOCHORTUS TOLMIEI WHOLE - 12 [hp_C]/mL
CLEMATIS VITALBA FLOWER - 12 [hp_C]/mL
CORN SILK - 12 [hp_C]/mL
DIPLACUS AURANTIACUS WHOLE - 12 [hp_C]/mL
ECHINACEA ANGUSTIFOLIA - 9 [hp_X]/mL
EHRENDORFERIA CHRYSANTHA WHOLE - 12 [hp_C]/mL
ERIODICTYON CALIFORNICUM FLOWERING TOP - 12 [hp_C]/mL
FUCHSIA MAGELLANICA WHOLE - 12 [hp_C]/mL
GOLDENSEAL - 9 [hp_X]/mL
LARIX DECIDUA FLOWERING TOP - 12 [hp_C]/mL
LATHYRUS ODORATUS FLOWER - 12 [hp_C]/mL
LONICERA CAPRIFOLIUM FLOWER - 12 [hp_C]/mL
POTASSIUM PHOSPHATE, DIBASIC - 15 [hp_C]/mL
ROSA CALIFORNICA WHOLE - 12 [hp_C]/mL
SALVIA ROSMARINUS FLOWER - 12 [hp_C]/mL
SODIUM CHLORIDE - 12 [hp_C]/mL
SULFUR - 1 [hp_Q]/mL
TARAXACUM OFFICINALE FLOWERING TOP - 9 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:SUBLINGUAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 12 Mar, 1996
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 13 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Apex Energetics Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:YQR8R0SQEA
5811MI029U
K73E24S6X9
831MXG026J
7SCP4N87CI
7D3VB244UX
TO6G4140YA
VB06AV5US8
68HKD4QMJR
HKE3DK7994
J66MJH220L
ZW3Z11D0JV
9UMZ642257
X3AJ4A1O73
5N1WD9784U
CI71S98N1Z
H14X4P9EKJ
NR1A27F29O
451W47IQ8X
70FD1KFU70
DQS85W46HV
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63479-0622-130 mL in 1 BOTTLE, GLASS (63479-0622-1)12 Mar, 1996N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Uses: for temporary relief of minor: tension* headache* sleep disturbances* fear* fatigue* sluggish mind* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

F22 somatica agrimony, calochortus tolmiei, cimicifuga racemosa, clematis vitalba, dandelion, diplacus aurantiacus, echinacea angustifolia, ehrendorferia chrysantha, fuchsia, hydrastis canadensis, kali phosphoricum, larix decidua, lathyrus odoratus, lonicera caprifolium, natrum muriaticum, rosa californica, rosmarinus officinalis, stigmata maidis, sulphur, yarrow, yerba santa rosa californica whole rosa californica whole echinacea angustifolia echinacea angustifolia lathyrus odoratus flower lathyrus odoratus flower achillea millefolium flower achillea millefolium flower fuchsia magellanica whole fuchsia magellanica whole corn silk corn silk taraxacum officinale flowering top taraxacum officinale flowering top ehrendorferia chrysantha whole ehrendorferia chrysantha whole goldenseal goldenseal potassium phosphate, dibasic potassium cation larix decidua flowering top larix decidua flowering top sulfur sulfur calochortus tolmiei whole calochortus tolmiei whole eriodictyon californicum flowering top eriodictyon californicum flowering top water alcohol black cohosh black cohosh diplacus aurantiacus whole diplacus aurantiacus whole lonicera caprifolium flower lonicera caprifolium flower agrimonia eupatoria flower agrimonia eupatoria flower sodium chloride sodium cation salvia rosmarinus flower salvia rosmarinus flower clematis vitalba flower clematis vitalba flower

Indications and Usage:

Uses: for temporary relief of minor: tension* headache* sleep disturbances* fear* fatigue* sluggish mind* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Warnings:

Warnings: if pregnant or breastfeeding , ask a health professional before use. do not use if clear seal over the cap is broken or missing. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. stop use and ask a doctor if tension, headache, sleep disturbances, fear, fatigue, sluggish mind, or other symptoms do not improve within 7 days or are accompanied by fever.

Dosage and Administration:

Directions: adults & children ages 12 years and over: take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. consult a physician for use in children under 12 years of age.

Stop Use:

Stop use and ask a doctor if tension, headache, sleep disturbances, fear, fatigue, sluggish mind, or other symptoms do not improve within 7 days or are accompanied by fever.

Package Label Principal Display Panel:

Futureplex® f22 flower essences somatica™ homeopathic formula tension* headache* sleep disturbances* 1 fl oz (30 ml) alcohol 20% by volume f22 somatica 20210331 label.jpg

Further Questions:

Distributed by apex energetics. questions? 16592 hale ave., irvine, ca 92606, usa


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.