Unda 27
Antimonium Crudum, Borago Officinalis, Cetraria Islandica, Drosera, Mentha Piperita, Senega Officinalis
Seroyal Usa
Human Otc Drug
NDC 62106-1126Unda 27 also known as Antimonium Crudum, Borago Officinalis, Cetraria Islandica, Drosera, Mentha Piperita, Senega Officinalis is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Unda 27 is 62106-1126. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Unda 27 drug includes Antimony Trisulfide - 12 [hp_X]/20mL Borage - 4 [hp_X]/20mL Cetraria Islandica Subsp. Islandica - 4 [hp_X]/20mL Drosera Rotundifolia Flowering Top - 4 [hp_X]/20mL Mentha Piperita - 4 [hp_X]/20mL Polygala Senega Root - 4 [hp_X]/20mL . The currest status of Unda 27 drug is Active.
Drug Information:
| Drug NDC: | 62106-1126 |
| 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 27 |
| 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: | Antimonium Crudum, Borago Officinalis, Cetraria Islandica, Drosera, Mentha Piperita, Senega Officinalis |
| 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: | ANTIMONY TRISULFIDE - 12 [hp_X]/20mL BORAGE - 4 [hp_X]/20mL CETRARIA ISLANDICA SUBSP. ISLANDICA - 4 [hp_X]/20mL DROSERA ROTUNDIFOLIA FLOWERING TOP - 4 [hp_X]/20mL MENTHA PIPERITA - 4 [hp_X]/20mL POLYGALA SENEGA ROOT - 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: | 21 Sep, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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 N0000185375 N0000185371 M0006342 M0016962
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | JWF5YAW3QW TF219GU161 2H1576D5WG PB618V0K2W 79Y1949PYO BJ7YPN79A1 79M2M2UDA9 9Q24RAI43V F79059A38U 639KR60Q1Q
Load more...V36I2B8LD5 U0NQ8555JD Q21UUL2105 F84709P2XV 9H58JRT35E CK15HA8438 IH3063S9MY 3M4G523W1G 00543AP1JV KPS1B1162N B10M69172N G0R4UBI2ZZ 597E9BI3Z3 997724QNDS 75O014T1HG M7T6H7D4IF 065C5D077J RV23PE6426 387GMG9FH5 Q4EWM09M3O
|
| 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] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food 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]
|
| 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] Dietary Proteins [CS] Plant Proteins [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]. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 62106-1126-8 | 1 BOTTLE, GLASS in 1 CARTON (62106-1126-8) / 20 mL in 1 BOTTLE, GLASS | 21 Sep, 2015 | N/A | No |
| 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 mild skin irritation.
Uses for the temporary relief of symptoms associated with mild anxiousness and nervousness.
Uses for the temporary relief of symptoms associated with coldness or numbness of the extremities.
Uses for the relief of symptoms associated with laryngitis and voice hoarseness.
Product Elements:
Unda 25 argentum metallicum, crataegus, gelsemium sempervirens, hamamelis virginiana, magnolia grandiflora, spiraea ulmaria, stannum metallicum, valeriana officinalis silver silver filipendula ulmaria root filipendula ulmaria root crataegus fruit crataegus fruit tin tin valerian valerian alcohol water gelsemium sempervirens root gelsemium sempervirens root hamamelis virginiana bark hamamelis virginiana bark magnolia grandiflora flower magnolia grandiflora flower unda 27 antimonium crudum, borago officinalis, cetraria islandica, drosera, mentha piperita, senega officinalis antimony trisulfide antimony trisulfide borage borage cetraria islandica subsp. islandica cetraria islandica subsp. islandica drosera rotundifolia flowering top drosera rotundifolia flowering top mentha piperita mentha piperita polygala senega root polygala senega root water alcohol unda 22 absinthium, aconitum napellus, argentum metallicum, boldo leaf, chamomilla, coffea tosta, jateorhiza palmata, manganum oxydatum nigrum, salvia officinalis manganese dioxide manganese dioxide sage sage alcohol water peumus boldus leaf peumus boldus leaf matricaria recutita matricaria recutita jateorhiza calumba root jateorhiza calumba root wormwood wormwood aconitum napellus aconitum napellus silver silver coffea arabica seed, roasted coffea arabica seed, roasted unda 12 argentum metallicum, aurum metallicum, dulcamara, fagopyrum esculentum, illicium verum, lappa major, salvia officinalis, sarsaparilla, staphysagria, viola tricolor gold gold solanum dulcamara top solanum dulcamara top fagopyrum esculentum fagopyrum esculentum star anise fruit star anise fruit arctium lappa root arctium lappa root sage sage sarsaparilla sarsaparilla delphinium staphisagria seed delphinium staphisagria seed water silver silver viola tricolor viola tricolor alcohol
Indications and Usage:
Uses for the temporary relief of symptoms associated with mild skin irritation. 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 mild anxiousness and nervousness. 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 coldness or numbness of the extremities. 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 relief of symptoms associated with laryngitis and voice hoarseness. 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 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.
Warnings 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.
Warnings 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.
Warnings ask a doctor before use if you have persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema and cough that is accompanied by excessive phlegm (mucus) or fever. stop use and ask a doctor if symptoms persist or worsen and 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. 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.
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 symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen and 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.
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.
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 62106-1152-8 unda numbered compounds unda 12 homeopathic preparation for the temporary relief of symptoms associated with mild skin irritation. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1152
Ndc 62106-1121-8 unda numbered compounds unda 22 homeopathic preparation for the temporary relief of symptoms associated with mild anxiousness and nervousness. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1121-8
Ndc 62106-1124-8 unda numbered compounds unda 25 homeopathic preparation for the temporary relief of symptoms associated with coldness or numbness of the extremities. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1124
Unda ndc 62106-1126-8 numbered compounds unda 27 homeopathic preparation for the relief of symptoms associated with laryngitis and voice hoarseness. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1126