Serene Sleep Spray
NDC Package 50181-0080-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Serene Sleep (eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox) sprays is supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. This formulation utilizes a spray delivery system. Marketed by The Wellness Center For Research A, this product is identified by NDC 50181-0080.

Identification & Billing

NDC Package Code
50181-0080-1
Package Description
30 mL in 1 BOTTLE, SPRAY
Product Code
50181-0080
11-Digit Billing Format
50181008001

Clinical Specifications

Proprietary Name
Serene Sleep
Non-Proprietary Name
Eschscholtzia Californica, Chamomilla, Cina, Coffea Cruda, Nux Vomica, Passiflora Incarnata, Pulsatilla (pratensis), Ignatia Amara, Kali Phosphoricum, Rhus Tox
Substance Name
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
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
The Wellness Center For Research A
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
02-14-2022
End Marketing Date
03-22-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50181-0080-1 identifies a specific commercial package of 30 ml in 1 bottle, spray of Serene Sleep, a human over the counter drug labeled by The Wellness Center For Research A. This spray is formulated for oral use and contains 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 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by The Wellness Center For Research A on February 14, 2022.

How is this The Wellness Center For Research A product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50181008001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
50181-0080-1
11-Digit CMS (5-4-2)
50181-0080-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.