Serene Sleep Spray
NDC 50181-0080

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50181-0080?
  4. Serene Sleep Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Serene Sleep (eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox) is a UNAPPROVED HOMEOPATHIC-approved product labeled by The Wellness Center For Research A. This medication is typically used as a allergens [cs]. It is supplied as a spray for oral administration. This product entry covers the primary NDC 50181-0080 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50181-0080
Proprietary Name:
Serene Sleep
Non-Proprietary Name: [1]
Eschscholtzia Californica, Chamomilla, Cina, Coffea Cruda, Nux Vomica, Passiflora Incarnata, Pulsatilla (pratensis), Ignatia Amara, Kali Phosphoricum, Rhus Tox
Substance Name: [2]
Arabica Coffee Bean; Artemisia Cina Pre-flowering Top; Dibasic Potassium Phosphate; Eschscholzia Californica Whole; Matricaria Chamomilla Whole; Passiflora Incarnata Flowering Top; Pulsatilla Pratensis Whole; Strychnos Ignatii Seed; Strychnos Nux-vomica Seed; Toxicodendron Pubescens Leaf
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
The Wellness Center For Research A
Labeler Code:
50181
Product Label ID:
2d5bbd0d-9b50-45ce-aa23-05bd05b54645
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
02-14-2022
End Marketing Date: [10]
03-22-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 50181-0080?

The NDC code 50181-0080 is assigned by the FDA to the product Serene Sleep. It is commonly known by its generic name, eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox. This pharmaceutical product is labeled by The Wellness Center For Research A and is currently categorized as listed product. The medication is a spray administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50181-0080-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort. Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • ESCHSCHOLZIA CALIFORNICA WHOLE (UNII: 9315HN272X)
  • ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X) (Active Moiety)
  • MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
  • MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (Active Moiety)
  • ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT)
  • ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (Active Moiety)
  • ARABICA COFFEE BEAN (UNII: 3SW678MX72)
  • ARABICA COFFEE BEAN (UNII: 3SW678MX72) (Active Moiety)
  • STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919)
  • STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (Active Moiety)
  • PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O)
  • PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (Active Moiety)
  • PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI)
  • PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (Active Moiety)
  • STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K)
  • STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (Active Moiety)
  • DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
  • PHOSPHATE ION (UNII: NK08V8K8HR) (Active Moiety)
  • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A)
  • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".