NDC 71919-618 Secale Cornutum

Claviceps Purpurea Sclerotium

NDC Product Code 71919-618

NDC CODE: 71919-618

Proprietary Name: Secale Cornutum 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: Claviceps Purpurea Sclerotium 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.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)

NDC Code Structure

NDC 71919-618-07

Package Description: 15 mL in 1 VIAL, GLASS

NDC 71919-618-08

Package Description: 30 mL in 1 VIAL, GLASS

NDC 71919-618-09

Package Description: 50 mL in 1 BOTTLE, GLASS

NDC 71919-618-10

Package Description: 100 mL in 1 BOTTLE, GLASS

NDC Product Information

Secale Cornutum with NDC 71919-618 is a a human over the counter drug product labeled by Washington Homeopathic Products. The generic name of Secale Cornutum is claviceps purpurea sclerotium. The product's dosage form is liquid and is administered via oral form.

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.

Secale Cornutum 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.

  • 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: Washington Homeopathic Products
Labeler Code: 71919
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: 12-10-2009 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: 12-31-2021 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.

Secale Cornutum Product Label Images

Secale Cornutum 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

Active Ingredients

SECALE

Uses

To relieve the symptoms of restlessness.

Keep Out Of Reach Of Children

Keep this and all medicines out of reach of children.

Indications

Indications: SECALE   Restlessness

Stop Use And Ask Doctor

If symptoms persist/worsen or if pregnant/nursing, consult your practitioner.

Directions

Adults: 4 drops into a tsp. of water 3 times a day. Children: 1/2 dose. Repeat at greater intervals as condition subsides. Or as directed bya lic. practitioner.

Inactive Ingredients

Sucrose/Lactose

* Please review the disclaimer below.