F22 Solution/ Drops
NDC 63479-0622
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
F22 (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 UNAPPROVED HOMEOPATHIC-approved product labeled by Apex Energetics Inc.. This medication is typically used as a increased large intestinal motility [pe]. It is supplied as a solution/ drops for sublingual administration. This product entry covers the primary NDC 63479-0622 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63479-0622
Proprietary Name:
F22 Somatica
Non-Proprietary Name: [1]
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
Substance Name: [2]
Achillea Millefolium Flower; Agrimonia Eupatoria Flower; Black Cohosh; Calochortus Tolmiei Whole; Clematis Vitalba Flower; Corn Silk; Diplacus Aurantiacus Whole; Echinacea Angustifolia; Ehrendorferia Chrysantha Whole; Eriodictyon Californicum Flowering Top; Fuchsia Magellanica Whole; Goldenseal; Larix Decidua Flowering Top; Lathyrus Odoratus Flower; Lonicera Caprifolium Flower; Potassium Phosphate, Dibasic; Rosa Californica Whole; Salvia Rosmarinus Flower; Sodium Chloride; Sulfur; Taraxacum Officinale Flowering Top
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Solution/ Drops
- A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
Sublingual - Administration beneath the tongue.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
63479
Product Label ID:
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Marketing Timeline
Start Marketing Date: [9]
03-12-1996
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 63479-0622?
The NDC code 63479-0622 is assigned by the FDA to the product F22 Somatica. It is commonly known by its generic 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. This pharmaceutical product is labeled by Apex Energetics Inc. and is currently categorized as listed product. The medication is a solution/ drops administered via sublingual route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63479-0622-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- ACHILLEA MILLEFOLIUM FLOWER 12 [hp_C]/mL - extracts made from ACHILLEA MILLEFOLIUM leaves and flowers
- 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 - A genus of perennial herbs used topically and internally. It contains echinacoside, GLYCOSIDES; INULIN; isobutyl amides, resin, and SESQUITERPENES.
- 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 - A ubiquitous sodium salt that is commonly used to season food.
- SULFUR 1 [hp_Q]/mL - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.
- TARAXACUM OFFICINALE FLOWERING TOP 9 [hp_X]/mL
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ROSA CALIFORNICA WHOLE (UNII: H14X4P9EKJ)
- ROSA CALIFORNICA WHOLE (UNII: H14X4P9EKJ) (Active Moiety)
- ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
- ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (Active Moiety)
- LATHYRUS ODORATUS FLOWER (UNII: X3AJ4A1O73)
- LATHYRUS ODORATUS FLOWER (UNII: X3AJ4A1O73) (Active Moiety)
- ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
- ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (Active Moiety)
- FUCHSIA MAGELLANICA WHOLE (UNII: J66MJH220L)
- FUCHSIA MAGELLANICA WHOLE (UNII: J66MJH220L) (Active Moiety)
- CORN SILK (UNII: 7D3VB244UX)
- CORN SILK (UNII: 7D3VB244UX) (Active Moiety)
- TARAXACUM OFFICINALE FLOWERING TOP (UNII: DQS85W46HV)
- TARAXACUM OFFICINALE FLOWERING TOP (UNII: DQS85W46HV) (Active Moiety)
- EHRENDORFERIA CHRYSANTHA WHOLE (UNII: 68HKD4QMJR)
- EHRENDORFERIA CHRYSANTHA WHOLE (UNII: 68HKD4QMJR) (Active Moiety)
- GOLDENSEAL (UNII: ZW3Z11D0JV)
- GOLDENSEAL (UNII: ZW3Z11D0JV) (Active Moiety)
- POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
- POTASSIUM CATION (UNII: 295O53K152) (Active Moiety)
- LARIX DECIDUA FLOWERING TOP (UNII: 9UMZ642257)
- LARIX DECIDUA FLOWERING TOP (UNII: 9UMZ642257) (Active Moiety)
- SULFUR (UNII: 70FD1KFU70)
- SULFUR (UNII: 70FD1KFU70) (Active Moiety)
- CALOCHORTUS TOLMIEI WHOLE (UNII: 831MXG026J)
- CALOCHORTUS TOLMIEI WHOLE (UNII: 831MXG026J) (Active Moiety)
- ERIODICTYON CALIFORNICUM FLOWERING TOP (UNII: HKE3DK7994)
- ERIODICTYON CALIFORNICUM FLOWERING TOP (UNII: HKE3DK7994) (Active Moiety)
- BLACK COHOSH (UNII: K73E24S6X9)
- BLACK COHOSH (UNII: K73E24S6X9) (Active Moiety)
- DIPLACUS AURANTIACUS WHOLE (UNII: TO6G4140YA)
- DIPLACUS AURANTIACUS WHOLE (UNII: TO6G4140YA) (Active Moiety)
- LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
- LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) (Active Moiety)
- AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U)
- AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U) (Active Moiety)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM CATION (UNII: LYR4M0NH37) (Active Moiety)
- SALVIA ROSMARINUS FLOWER (UNII: NR1A27F29O)
- SALVIA ROSMARINUS FLOWER (UNII: NR1A27F29O) (Active Moiety)
- CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI)
- CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- WATER (UNII: 059QF0KO0R)
- ALCOHOL (UNII: 3K9958V90M)
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Potassium Compounds - [CS]
- Potassium Salt - [EPC] (Established Pharmacologic Class)
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
