NDC 66579-0049 Calm

  1. Labeler Index
  2. New Sun Inc.
  3. NDC: 66579-0049 Calm

NDC Product Code 66579-0049

NDC CODE: 66579-0049

Proprietary Name: Calm 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: 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

NDC 66579-0049-1

Package Description: 29 mL in 1 BOTTLE, SPRAY

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Calm with NDC 66579-0049 is a product labeled by New Sun Inc.. The generic name of Calm is . The product's dosage form is and is administered via form.

Labeler Name: New Sun Inc.

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.
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: New Sun Inc.
Labeler Code: 66579
Start Marketing Date: 07-29-2014 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: 12-31-2018 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 Product Label Images

Calm 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

Dosage & Administration

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.Adult Dose: 3 Pump SpraysChild's Dose (2-12): 2 Pump Sprays

Warnings

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Purpose

Indications: For temporary relief of: stress induced states such as: •nervous tension •minor anxieties •fearfulness •over-sensitivity

Otc - Active Ingredient

Active Ingredients: ​Aconitum napellus, Alfalfa, Argentum nitricum, Avena sativa, Chamomilla, Gelsemium sempervirens, Glonoinum, Histaminum hydrochloricum, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Veratrum album. ​Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

Inactive Ingredient

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

Indications & Usage

  • Indications: For temporary relief of: stress induced states such as:nervous tensionminor anxietyfearfulnessover-sensitivityFor promoting:calmconfidence

* Please review the disclaimer below.