NDC 51393-5006 Calm Mood

Garlic, Avena Sativa Flowering Top, Angelica Archangelica Root, Arabica Coffee Bean, Holy Basil Leaf, Passiflora Edulis Flower, Scutellaria Lateriflora Whole, Verbena Hastata Top, And Macropiper Methysticum Root Solution/ Drops Sublingual

NDC Product Code 51393-5006

NDC CODE: 51393-5006

Proprietary Name: Calm Mood 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: Garlic, Avena Sativa Flowering Top, Angelica Archangelica Root, Arabica Coffee Bean, Holy Basil Leaf, Passiflora Edulis Flower, Scutellaria Lateriflora Whole, Verbena Hastata Top, And Macropiper Methysticum Root 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 active ingredientspurposeallium sativumusda certified organic 89cremedy for nervousness/restlessness avena sativa 30xfor nervous exhaustionangelica 89cfor difficulty concentrating, unable to focuscoffea cruda 30cto calm the system, nervousnessocimum 89cfor anxietypassiflora 30cquieting effect on the nervous systemscutellaria lateriflora 12crestlessness, nervousnessverbena 6ceases nervous system, helps mood swingspiper methysticum 30cfor impaired thinking, sluggish emotion

NDC Code Structure

NDC 51393-5006-1

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON > 10 mL in 1 BOTTLE, DISPENSING

NDC 51393-5006-3

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Calm Mood with NDC 51393-5006 is a human over the counter drug product labeled by Forces Of Nature. The generic name of Calm Mood is garlic, avena sativa flowering top, angelica archangelica root, arabica coffee bean, holy basil leaf, passiflora edulis flower, scutellaria lateriflora whole, verbena hastata top, and macropiper methysticum root. The product's dosage form is solution/ drops and is administered via sublingual form.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Calm Mood 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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)

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.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.


Product Labeler Information

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

Labeler Name: Forces Of Nature
Labeler Code: 51393
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: 01-01-2021 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: 12-31-2022 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.

Calm Mood 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

Drug Facts

Manufactured & Distributed by Forces of Nature, Inc.21787 8th St East #3A Sonoma, CA 95476 USA

Otc - Purpose

Active ingredientsPurposeAllium sativumUSDA Certified Organic 89CRemedy for Nervousness/Restlessness Avena sativa 30XFor Nervous ExhaustionAngelica 89CFor Difficulty Concentrating, Unable to FocusCoffea cruda 30CTo Calm the System, NervousnessOcimum 89CFor AnxietyPassiflora 30CQuieting Effect on the Nervous SystemScutellaria lateriflora 12CRestlessness, NervousnessVerbena 6CEases Nervous System, Helps Mood SwingsPiper methysticum 30CFor Impaired Thinking, Sluggish Emotion

Uses

For the relief of nervousness and tension often associated with stress/anxiety.

Warnings

For oral (sublingual) use.

Otc - Ask Doctor

Ask a doctor before use in children under 6 years of age.

Otc - Stop Use

Stop use and ask doctor if symptoms persist for more than 3 days or worsen.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Use as needed. For best results, use at the first sign of symptoms. Shake well before use. For stress/anxiety: Take 5-10 drops under the tongue. Repeat 3-4 times per day when experiencing symptoms.

Other Information

  • Store in a cool, dark place

Inactive Ingredients

Distilled Water, Grain Alcohol, Lavender Oil

* Please review the disclaimer below.