Unda 35

Aurum Metallicum, Corallium Rubrum Exoskeleton, Crataegus, Grindelia, Hamamelis Virginiana, Mentha Piperita, Myrtus Communis


Seroyal Usa
Human Otc Drug
NDC 62106-1134
Unda 35 also known as Aurum Metallicum, Corallium Rubrum Exoskeleton, Crataegus, Grindelia, Hamamelis Virginiana, Mentha Piperita, Myrtus Communis is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Unda 35 is 62106-1134. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Unda 35 drug includes Corallium Rubrum Exoskeleton - 12 [hp_X]/20mL Crataegus Fruit - 4 [hp_X]/20mL Gold - 12 [hp_X]/20mL Grindelia Hirsutula Flowering Top - 4 [hp_X]/20mL Hamamelis Virginiana Root Bark/stem Bark - 4 [hp_X]/20mL Mentha Piperita - 4 [hp_X]/20mL Myrtus Communis Top - 4 [hp_X]/20mL . The currest status of Unda 35 drug is Active.

Drug Information:

Drug NDC: 62106-1134
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: Unda 35
Also known as the trade name. It is the name of the product chosen by the labeler.
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: Aurum Metallicum, Corallium Rubrum Exoskeleton, Crataegus, Grindelia, Hamamelis Virginiana, Mentha Piperita, Myrtus Communis
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Seroyal Usa
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:CORALLIUM RUBRUM EXOSKELETON - 12 [hp_X]/20mL
CRATAEGUS FRUIT - 4 [hp_X]/20mL
GOLD - 12 [hp_X]/20mL
GRINDELIA HIRSUTULA FLOWERING TOP - 4 [hp_X]/20mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 4 [hp_X]/20mL
MENTHA PIPERITA - 4 [hp_X]/20mL
MYRTUS COMMUNIS TOP - 4 [hp_X]/20mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 10 Sep, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 13 Jun, 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:Seroyal USA
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.
NUI:N0000185508
N0000175629
N0000184306
M0000728
N0000185021
N0000185001
M0002274
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:KPS1B1162N
Q21UUL2105
IDB0NAZ6AI
18E7415PXQ
79Y1949PYO
T7S323PKJS
2CA71K0DLE
79M2M2UDA9
367E55FXGW
C88X29Y479
7S82P3R43Z
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 EPC:Standardized Chemical Allergen [EPC]
Standardized Insect Venom Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Allergens [CS]
Bee Venoms [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Allergens [CS]
Cell-mediated Immunity [PE]
Increased Histamine Release [PE]
Standardized Chemical Allergen [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
62106-1134-81 BOTTLE, GLASS in 1 CARTON (62106-1134-8) / 20 mL in 1 BOTTLE, GLASS10 Sep, 2015N/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 the temporary relief of symptoms associated with cough.

Uses for the temporary relief of symptoms associated with common colds.

Product Elements:

Unda 35 aurum metallicum, corallium rubrum exoskeleton, crataegus, grindelia, hamamelis virginiana, mentha piperita, myrtus communis gold gold corallium rubrum exoskeleton corallium rubrum exoskeleton crataegus fruit crataegus fruit grindelia hirsutula flowering top grindelia hirsutula flowering top hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark mentha piperita mentha piperita myrtus communis top myrtus communis top alcohol water unda 710 apis mellifica, calendula officinalis, lycopodium clavatum, dulcamara, aurum metallicum lycopodium clavatum spore lycopodium clavatum spore solanum dulcamara top solanum dulcamara top gold gold calendula officinalis flowering top calendula officinalis flowering top water alcohol apis mellifera apis mellifera

Indications and Usage:

Uses for the temporary relief of symptoms associated with cough. directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.

Uses for the temporary relief of symptoms associated with common colds. directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.

Warnings:

Warnings ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. cough that is accompanied by excessive phlegm (mucus) or fever. stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting maybe serious. consult physician promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by physician. stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Do Not Use:

Warnings ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. cough that is accompanied by excessive phlegm (mucus) or fever. stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting maybe serious. consult physician promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by physician. stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Dosage and Administration:

Directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.

Directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.

Stop Use:

Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. symptoms persist or worsen.

Overdosage:

In case of overdose, get medical help or contact a poison control center right away.

In case of overdose, get medical help or contact a poison control center right away.

Package Label Principal Display Panel:

Ndc 62106-1134-8 unda numbered compounds unda 35 homeopathic preparation for the temporary relief of symptoms associated with cough. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1134

Ndc 62106-1172-8 unda numbered compounds unda 710 homeopathic preparation for the temporary relief of symptoms associated with common colds. contains 30% alcohol 0.7 fl oz (20 ml) 62106-1172-8


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.