I-sleep Liquid
NDC Package 55714-2568-1

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

Package Information

I-sleep (absinthium, anacardium orientale, arg. nit., arsenicum alb., belladonna, bryonia, calc. carb., camphora, chamomilla, cimicifuga, cinchona, coffea cruda, cypripedium, gelsemium, humulus, hyoscyamus, ignatia, kali brom., nux vom., passiflora, pulsatilla, scutellaria lateriflora, sepia, thuja occ., valeriana) liquids is formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking. This formulation utilizes a liquid delivery system. Marketed by Newton Laboratories, Inc., this product is identified by NDC 55714-2568.

Identification & Billing

NDC Package Code
55714-2568-1
Package Description
30 mL in 1 BOTTLE, GLASS
Product Code
55714-2568
11-Digit Billing Format
55714256801

Clinical Specifications

Proprietary Name
I-sleep
Non-Proprietary Name
Absinthium, Anacardium Orientale, Arg. Nit., Arsenicum Alb., Belladonna, Bryonia, Calc. Carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea Cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali Brom., Nux Vom., Passiflora, Pulsatilla, Scutellaria Lateriflora, Sepia, Thuja Occ., Valeriana
Substance Name
Anemone Pulsatilla; Arabica Coffee Bean; Arsenic Trioxide; Atropa Belladonna; Black Cohosh; Bryonia Alba Root; Camphor (natural); Cinchona Officinalis Bark; Cypripedium Parviflorum Var. Pubescens Root; Gelsemium Sempervirens Root; Hops; Hyoscyamus Niger; Matricaria Chamomilla; Oyster Shell Calcium Carbonate, Crude; Passiflora Incarnata Flowering Top; Potassium Bromide; Scutellaria Lateriflora Whole; Semecarpus Anacardium Juice; Sepia Officinalis Juice; Silver Nitrate; Strychnos Ignatii Seed; Strychnos Nux-vomica Seed; Thuja Occidentalis Leafy Twig; Valerian; Wormwood
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.

Regulatory & Marketing

Labeler Name
Newton Laboratories, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
02-01-2021
Listing Expiration
12-31-2026
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 55714-2568-1 identifies a specific commercial package of 30 ml in 1 bottle, glass of I-sleep, a human over the counter drug labeled by Newton Laboratories, Inc.. This liquid is formulated for oral use and contains anemone pulsatilla; arabica coffee bean; arsenic trioxide; atropa belladonna; black cohosh; bryonia alba root; camphor (natural); cinchona officinalis bark; cypripedium parviflorum var. pubescens root; gelsemium sempervirens root; hops; hyoscyamus niger; matricaria chamomilla; oyster shell calcium carbonate, crude; passiflora incarnata flowering top; potassium bromide; scutellaria lateriflora whole; semecarpus anacardium juice; sepia officinalis juice; silver nitrate; strychnos ignatii seed; strychnos nux-vomica seed; thuja occidentalis leafy twig; valerian; wormwood 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 Newton Laboratories, Inc. on February 01, 2021. The current certification is valid through December 31, 2026.

How is this Newton Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55714256801. 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)
55714-2568-1
11-Digit CMS (5-4-2)
55714-2568-01

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