NDC 62106-1130 Unda 31

Argentum Metallicum, Camphora, Carduus Benedictus, Juniperus Communis, Lappa Major, Robinia Pseudoacacia

NDC Product Code 62106-1130

NDC Code: 62106-1130

Proprietary Name: Unda 31 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Argentum Metallicum, Camphora, Carduus Benedictus, Juniperus Communis, Lappa Major, Robinia Pseudoacacia 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.

NDC Code Structure

  • 62106 - Seroyal Usa
    • 62106-1130 - Unda 31

NDC 62106-1130-8

Package Description: 1 BOTTLE, GLASS in 1 CARTON > 20 mL in 1 BOTTLE, GLASS

NDC Product Information

Unda 31 with NDC 62106-1130 is a a human over the counter drug product labeled by Seroyal Usa. The generic name of Unda 31 is argentum metallicum, camphora, carduus benedictus, juniperus communis, lappa major, robinia pseudoacacia. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Seroyal Usa

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.

Product Type: Human Otc Drug 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.

Unda 31 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SILVER 12 [hp_X]/20mL
  • CINNAMOMUM CAMPHORA WHOLE 12 [hp_X]/20mL
  • CENTAUREA BENEDICTA 4 [hp_X]/20mL
  • JUNIPERUS COMMUNIS WHOLE 4 [hp_X]/20mL
  • ARCTIUM LAPPA ROOT 4 [hp_X]/20mL
  • ROBINIA PSEUDOACACIA BARK 4 [hp_X]/20mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Seroyal Usa
Labeler Code: 62106
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 03-27-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Unda 31 Product Label Images

Unda 31 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredientsEach drop contains:

Argentum metallicum (Silver) 12X

Camphora (Camphor from Cinnamomum camphora) 12X

Carduus benedictus (Blessed Thistle) Aerial Parts 4X

Juniperus communis (Common juniper) Berry 4X

Lappa major (Great Burdock) Root 4X

Robinia pseudoacacia (Black locust) Bark 4X

Otc - Purpose

Uses

For the temporary relief of symptoms

associated with mild stomach upset.

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Other Safety Information

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

Inactive Ingredient

Inactive ingredients

Ethanol (beet), purified water

Dosage & 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.

Indications & Usage

Uses

For the temporary relief of symptoms associated with mild stomach 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.

* Please review the disclaimer below.

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