NDC 58264-0015 D-15

Rosa Canina Fruit, Anamirta Cocculus Seed, Phosphoric Acid, Chamaelirium Luteum Root, Strychnos Ignatii Seed, Zinc, And Honey Solution Sublingual

  1. Labeler Index
  2. Dna Labs, Inc.
  3. NDC: 58264-0015 D-15

NDC Product Code 58264-0015

NDC CODE: 58264-0015

Proprietary Name: D-15 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: Rosa Canina Fruit, Anamirta Cocculus Seed, Phosphoric Acid, Chamaelirium Luteum Root, Strychnos Ignatii Seed, Zinc, And Honey 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used as conditions of nervous exhaustion.

NDC Code Structure

NDC 58264-0015-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC Product Information

D-15 with NDC 58264-0015 is a human over the counter drug product labeled by Dna Labs, Inc.. The generic name of D-15 is rosa canina fruit, anamirta cocculus seed, phosphoric acid, chamaelirium luteum root, strychnos ignatii seed, zinc, and honey. The product's dosage form is solution and is administered via sublingual form.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

D-15 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.

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.
  • Sublingual - Administration beneath the tongue.

Product Labeler Information

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

Labeler Name: Dna Labs, Inc.
Labeler Code: 58264
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: 01-01-1990 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: 12-31-2023 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

D-15 Product Label Images

D-15 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

Other

NDC 58264-0015-1

To be used according to standard homeopathic indications.

Otc - Purpose

Conditions of nervous exhaustion.

Active

Rosa canina 1x, Cocculus indicus 6x, Acidum phosphoricum 3x, Helonias dioica 6x, Ignatia amara 6x, Zincum metallicum 6x, Raw honey 1x

Inactive

20% alcohol in purified water.

Suggested Dosage

One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

Storage And Handling

SHAKE WELL

Warnings

  • Use only if cap seal is unbroken.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep this and all medication out of the reach of children.

* Please review the disclaimer below.