NDC 61096-2001 Sleepease

Aquilegia, Avena, Chamomilla, Coffea Cruda, Cypripedium, Humulus, Kali Phos, Passiflora, Valeriana, Zinc Met

NDC Product Code 61096-2001

NDC Code: 61096-2001

Proprietary Name: Sleepease 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: Aquilegia, Avena, Chamomilla, Coffea Cruda, Cypripedium, Humulus, Kali Phos, Passiflora, Valeriana, Zinc Met 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

  • 61096 - Eight & Company L.l.c
    • 61096-2001 - Sleepease

NDC 61096-2001-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 41 mL in 1 BOTTLE, SPRAY

NDC Product Information

Sleepease with NDC 61096-2001 is a a human prescription drug product labeled by Eight & Company L.l.c. The generic name of Sleepease is aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Eight & Company L.l.c

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 Prescription 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.

Sleepease 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.

  • AQUILEGIA VULGARIS 4 [hp_X]/41mL
  • AVENA SATIVA FLOWERING TOP 4 [hp_X]/41mL
  • MATRICARIA RECUTITA 4 [hp_X]/41mL
  • ARABICA COFFEE BEAN 200 [hp_C]/41mL
  • CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 4 [hp_X]/41mL
  • HOPS 4 [hp_X]/41mL
  • POTASSIUM PHOSPHATE, DIBASIC 12 [hp_X]/41mL
  • PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X]/41mL
  • VALERIAN 4 [hp_X]/41mL
  • ZINC 12 [hp_X]/41mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Dietary Proteins - [CS]
  • Plant Proteins - [CS]
  • Seed Storage Proteins - [CS]
  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Dietary Proteins - [CS]
  • Plant Proteins - [CS]
  • Food Additives - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eight & Company L.l.c
Labeler Code: 61096
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: 04-24-2019 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’.

* Please review the disclaimer below.

Sleepease Product Label Images

Sleepease Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredient: Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.

Warnings

Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

  • Temporarily relieves the common symptoms of sleeplessness, including:wakefulnessrestlessnessemotional stress and anxietycaffeine sensitivity

Dosage & Administration

  • Directions:Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.Children Under 12: consult a health care professional.

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Non-GMO Glycerin, organic alcohol 20% v/v, purified water.

Otc - Purpose

Temporarily relieves the common symptoms of sleeplessness, including:° wakefulness° restlessness° emotional stress and anxiety° caffeine sensitivity° natural° gluten free° no artifical flavors or colors° vegan° no known negative side effects° no known negative drug interactions

* Please review the disclaimer below.

Previous Code
61096-1039
Next Code
61096-2006