Sleepease Liquid
NDC Package 61096-2001-1
Package Information
Sleepease (aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met) liquids is temporarily relieves the common symptoms of sleeplessness, including:wakefulnessrestlessnessemotional stress and anxietycaffeine sensitivity. This formulation utilizes a liquid delivery system. Marketed by Eight & Company L.l.c, this product is identified by NDC 61096-2001.
Identification & Billing
Clinical Specifications
- AQUILEGIA VULGARIS 4 [hp_X]/41mL
- ARABICA COFFEE BEAN 200 [hp_C]/41mL
- AVENA SATIVA FLOWERING TOP 4 [hp_X]/41mL
- CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 4 [hp_X]/41mL
- DIBASIC POTASSIUM PHOSPHATE 12 [hp_X]/41mL
- HOPS 4 [hp_X]/41mL
- MATRICARIA CHAMOMILLA WHOLE 4 [hp_X]/41mL
- PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X]/41mL
- VALERIAN 4 [hp_X]/41mL
- ZINC 12 [hp_X]/41mL
- Allergens - [CS]
- Allergens - [CS]
- Cell-mediated Immunity - [PE] (Physiologic Effect)
- Dietary Proteins - [CS]
- Food Additives - [CS]
- Increased Histamine Release - [PE] (Physiologic Effect)
- Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Plant Proteins - [CS]
- Seed Storage Proteins - [CS]
Regulatory & Marketing
Hierarchy Structure
- 61096 - Eight & Company L.l.c
- 61096-2001 - Sleepease
- 61096-2001-1 - 1 BOTTLE, SPRAY in 1 CARTON / 41 mL in 1 BOTTLE, SPRAY
- 61096-2001 - Sleepease
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 61096-2001-1 identifies a specific commercial package of 1 bottle, spray in 1 carton / 41 ml in 1 bottle, spray of Sleepease, a human over the counter drug labeled by Eight & Company L.l.c. This liquid is formulated for oral use and contains aquilegia vulgaris; arabica coffee bean; avena sativa flowering top; cypripedium parviflorum var. pubescens root; dibasic potassium phosphate; hops; matricaria chamomilla whole; passiflora incarnata flowering top; valerian; zinc 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 Eight & Company L.l.c on April 24, 2019. The current certification is valid through December 31, 2026.
How is this Eight & Company L.l.c product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 61096200101. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.