Sepia Plex Liquid
NDC 62106-0117

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 62106-0117?
  4. Sepia Plex Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Sepia Plex (aconitum napellus, cimicifuga racemosa, lachesis mutus, melissa officinalis, platinum metallicum, sanguinaria canadensis, sepia, sulphuricum acidum, valeriana officinalis) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Seroyal Usa. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 62106-0117 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
62106-0117
Proprietary Name:
Sepia Plex
Non-Proprietary Name: [1]
Aconitum Napellus, Cimicifuga Racemosa, Lachesis Mutus, Melissa Officinalis, Platinum Metallicum, Sanguinaria Canadensis, Sepia, Sulphuricum Acidum, Valeriana Officinalis
Substance Name: [2]
Aconitum Napellus; Black Cohosh; Lachesis Muta Venom; Melissa Officinalis; Platinum; Sanguinaria Canadensis Root; Sepia Officinalis Juice; Sulfuric Acid; Valerian
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Seroyal Usa
Labeler Code:
62106
Product Label ID:
4c4a0a95-3848-4e19-e054-00144ff8d46c
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
04-03-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 62106-0117?

The NDC code 62106-0117 is assigned by the FDA to the product Sepia Plex. It is commonly known by its generic name, aconitum napellus, cimicifuga racemosa, lachesis mutus, melissa officinalis, platinum metallicum, sanguinaria canadensis, sepia, sulphuricum acidum, valeriana officinalis. This pharmaceutical product is labeled by Seroyal Usa and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 62106-0117-0. 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?

Uses For the temporary relief of symptoms associated with menopause.Directions To be taken ten minutes away from food. Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. Hold contents for about 20 seconds and swallow. To promote drop flow, invert bottle and shake before each use. Dosage frequency may be increased up to six times daily depending on the severity of symptoms. Adults: Take 10 drops three times daily or as recommended by your healthcare practitioner.

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.
  • ACONITUM NAPELLUS 6 [hp_X]/30mL - A plant genus of the family RANUNCULACEAE. Members contain a number of diterpenoid alkaloids including: aconitans, hypaconitine, ACONITINE, jesaconitine, ignavine, napelline, and mesaconitine. The common name of Wolfbane is similar to the common name for ARNICA.
  • BLACK COHOSH 3 [hp_X]/30mL
  • LACHESIS MUTA VENOM 8 [hp_X]/30mL
  • MELISSA OFFICINALIS 2 [hp_X]/30mL - A plant genus of the family LAMIACEAE. The common names of beebalm or lemonbalm are also used for MONARDA.
  • PLATINUM 8 [hp_X]/30mL - A heavy, soft, whitish metal, resembling tin, with atomic number 78, atomic weight 195.084, symbol Pt. It is used in manufacturing equipment for laboratory and industrial use. It occurs as a black powder (platinum black) and as a spongy substance (spongy platinum) and may have been known in Pliny's time as alutiae.
  • SANGUINARIA CANADENSIS ROOT 3 [hp_X]/30mL
  • SEPIA OFFICINALIS JUICE 3 [hp_X]/30mL
  • SULFURIC ACID 6 [hp_X]/30mL - Inorganic and organic derivatives of sulfuric acid (H2SO4). The salts and esters of sulfuric acid are known as SULFATES and SULFURIC ACID ESTERS respectively.
  • VALERIAN 6 [hp_X]/30mL - A plant genus of the family VALERIANACEAE, order Dipsacales, subclass Asteridae, class Magnoliopsida. It is best known for the sedative use and valepotriate content of the roots. It is sometimes called Garden Heliotrope but is unrelated to true Heliotrope (HELIOTROPIUM).

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

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:

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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".