Unda 21
Condurango, Calendula Officinalis, Camphora, Hydrastis Canadensis, Thuja Occidentalis, Aluminium Metallicum, Aurum Metallicum
Seroyal Usa
Human Otc Drug
NDC 62106-1120Unda 21 also known as Condurango, Calendula Officinalis, Camphora, Hydrastis Canadensis, Thuja Occidentalis, Aluminium Metallicum, Aurum Metallicum is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Unda 21 is 62106-1120. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Unda 21 drug includes Aluminum - 12 [hp_X]/20mL Calendula Officinalis Flowering Top - 4 [hp_X]/20mL Camphor (natural) - 4 [hp_X]/20mL Gold - 12 [hp_X]/20mL Goldenseal - 4 [hp_X]/20mL Marsdenia Condurango Bark - 4 [hp_X]/20mL Thuja Occidentalis Leafy Twig - 4 [hp_X]/20mL . The currest status of Unda 21 drug is Active.
Drug Information:
| Drug NDC: | 62106-1120 |
| 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 21 |
| 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: | Condurango, Calendula Officinalis, Camphora, Hydrastis Canadensis, Thuja Occidentalis, Aluminium Metallicum, Aurum Metallicum |
| 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: | ALUMINUM - 12 [hp_X]/20mL CALENDULA OFFICINALIS FLOWERING TOP - 4 [hp_X]/20mL CAMPHOR (NATURAL) - 4 [hp_X]/20mL GOLD - 12 [hp_X]/20mL GOLDENSEAL - 4 [hp_X]/20mL MARSDENIA CONDURANGO BARK - 4 [hp_X]/20mL THUJA OCCIDENTALIS LEAFY TWIG - 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: | 26 May, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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. |
| UPC: | 0883196301607 0883196305605
|
| UPC stands for Universal Product Code. |
| NUI: | N0000185508 N0000175629 N0000184306 M0000728 N0000185375 N0000185371 M0006342 M0016962 M0022575 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185019 N0000185001 M0516536
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | N20HL7Q941 CPD4NFA903 E55SMD6DA8 654825W09Z 2H1576D5WG 79Y1949PYO QH89N6B02U R23QIR6YBA 1NT28V9397 ZW3Z11D0JV
Load more...7TPC058OWY 00UK7646FG 18E7415PXQ AWN2M136UL 3M4G523W1G 8L72OKJ7II IHN2NQ5OF9 789U1901C5 1V3SHR7QB7 S7V92P67HO W6LFQ57E4M S546YLW6E6 269XH13919 492225Q21H 0R715588D2 26ZE1BZ2US M9VVZ08EKQ 2P299V784P
|
| 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] Copper-containing Intrauterine Device [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] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [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] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] Copper [CS] Seed Storage 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]. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 62106-1120-8 | 1 BOTTLE, GLASS in 1 CARTON (62106-1120-8) / 20 mL in 1 BOTTLE, GLASS | 26 May, 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 mild fever.
Uses for the temporary relief of symptoms associated with digestive upset.
Uses for the temporary relief of symptoms associated with menses and tiredness
Uses for the temporary relief of symptoms associated with mild dandruff.
Uses for the relief of symptoms associated with muscular weakness in the elderly.
Product Elements:
Unda 41 primula veris, rheum, juglans regia, sarsaparilla, nux vomica, symphytum officinale, plumbum metallicum sarsaparilla sarsaparilla primula veris primula veris strychnos nux-vomica seed strychnos nux-vomica seed comfrey root comfrey root lead lead alcohol water rheum tanguticum whole rheum tanguticum whole english walnut english walnut unda 40 capsicum annuum, pilocarpus, thymus vulgaris, urtica urens, aurum metallicum, cuprum metallicum thymus vulgaris whole thymus vulgaris whole water pilocarpus jaborandi leaf pilocarpus jaborandi leaf capsicum capsicum urtica urens urtica urens alcohol gold gold copper copper unda 20 aluminium metallicum, argentum metallicum, arsenicum album, aurum metallicum, calendula officinalis, condurango, jacaranda caroba, robinia pseudoacacia, sabina aluminum aluminum silver silver arsenic trioxide arsenic cation (3+) gold gold calendula officinalis flowering top calendula officinalis flowering top marsdenia condurango bark marsdenia condurango bark jacaranda caroba leaf jacaranda caroba leaf robinia pseudoacacia bark robinia pseudoacacia bark juniperus sabina leaf juniperus sabina leaf alcohol water unda 21 condurango, calendula officinalis, camphora, hydrastis canadensis, thuja occidentalis, aluminium metallicum, aurum metallicum marsdenia condurango bark marsdenia condurango bark calendula officinalis flowering top calendula officinalis flowering top camphor (natural) camphor (natural) goldenseal goldenseal thuja occidentalis leafy twig thuja occidentalis leafy twig aluminum aluminum gold gold alcohol water unda 15 allium cepa, aurum metallicum, eucalyptus globulus, inula helenium, trigonella foenum-graecum onion onion gold gold eucalyptus globulus leaf eucalyptus globulus leaf inula helenium root inula helenium root fenugreek seed fenugreek seed alcohol water
Indications and Usage:
Uses for the temporary relief of mild fever. 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 digestive upset. 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 menses and tiredness 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 dandruff. 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 muscular weakness in the elderly. 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:
Warning: 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 you are 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 if you are pregnant or breastfeeding, ask a healthcare practitioner before use. 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 symptoms persist or worsen.
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.
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:
Stope use and aks 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.
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.
In case of overdose, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Ndc 62106-1139-8 unda numbered compounds unda 40 homeopathic preparation for the temporary relief of symptoms associated with mild dandruff. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1139
Ndc 62106-1114-8 unda numbered compounds unda 15 homeopathic preparation for the temporary relief of mild fever. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1114-8
Ndc 62106-1120-8 unda numbered compounds unda 21 homeopathic preparation for the temporary relief of symptoms associated with menses and tiredness. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1120
Ndc 62106-1119-8 unda numbered compounds unda 20 homeopathic preparation for the temporary relief of symptoms associated with digestive upset. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1119-8
Ndc 62106-1140-8 unda numbered compounds unda 41 homeopathic preparation for the temporary relief of symptoms associated with muscular weakness. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1140