NDC 70476-0004 Quiet Calm

Avena Sativa, Ammonium Bromatum, Chamomilla, Coffea Cruda, Gelsemium Sempervirens, L-tryptophan, Phosphoricum Acidum, Valeriana Officinalis

NDC Product Code 70476-0004

NDC Code: 70476-0004

Proprietary Name: Quiet 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: Avena Sativa, Ammonium Bromatum, Chamomilla, Coffea Cruda, Gelsemium Sempervirens, L-tryptophan, Phosphoricum Acidum, Valeriana Officinalis 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

  • 70476 - Holistic Haven

NDC 70476-0004-1

Package Description: 59 mL in 1 BOTTLE, DROPPER

NDC Product Information

Quiet Calm with NDC 70476-0004 is a a human over the counter drug product labeled by Holistic Haven. The generic name of Quiet Calm is avena sativa, ammonium bromatum, chamomilla, coffea cruda, gelsemium sempervirens, l-tryptophan, phosphoricum acidum, valeriana officinalis. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Holistic Haven

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.

Quiet Calm 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.

  • TRYPTOPHAN 6 [hp_X]/mL
  • VALERIAN 30 [hp_X]/mL

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: Holistic Haven
Labeler Code: 70476
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: 10-10-2019 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: 12-31-2020 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’.

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Quiet Calm Product Label Images