NDC 68703-346 Good Night Sleep

Aconitum Nap, Aesculus Hipp, Flos, Avena, Cocculus, Coffea Cruda, Hyoscyamus, Ignatia, Passiflora, Pulsatilla Nutt, Staphysag, Valeriana

NDC Product Code 68703-346

NDC CODE: 68703-346

Proprietary Name: Good Night Sleep 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: Aconitum Nap, Aesculus Hipp, Flos, Avena, Cocculus, Coffea Cruda, Hyoscyamus, Ignatia, Passiflora, Pulsatilla Nutt, Staphysag, Valeriana 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

  • 68703 - Silver Star Brands

NDC 68703-346-02

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Good Night Sleep with NDC 68703-346 is a a human over the counter drug product labeled by Silver Star Brands. The generic name of Good Night Sleep is aconitum nap, aesculus hipp, flos, avena, cocculus, coffea cruda, hyoscyamus, ignatia, passiflora, pulsatilla nutt, staphysag, valeriana. The product's dosage form is spray and is administered via oral form.

Labeler Name: Silver Star Brands

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc 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.

Good Night Sleep 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.

  • ACONITUM NAPELLUS 10 [hp_X]/59mL
  • AESCULUS HIPPOCASTANUM FLOWER 10 [hp_X]/59mL
  • HYOSCYAMUS NIGER 10 [hp_X]/59mL
  • VALERIANA OFFICINALIS WHOLE 10 [hp_X]/59mL
  • AVENA SATIVA LEAF 10 [hp_X]/59mL
  • PASSIFLORA INCARNATA FLOWER 10 [hp_X]/59mL
  • ANAMIRTA COCCULUS SEED 10 [hp_X]/59mL
  • DELPHINIUM STAPHISAGRIA SEED 10 [hp_X]/59mL
  • STRYCHNOS IGNATII WHOLE 10 [hp_X]/59mL
  • COFFEA ARABICA FRUIT 10 [hp_X]/59mL
  • ANEMONE PATENS WHOLE 10 [hp_X]/59mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLUCOSYL STEVIOL (UNII: TKD5UC898Q)
  • BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY)
  • WATER (UNII: 059QF0KO0R)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • CARYA OVATA BARK (UNII: X765CF609L)

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.

Product Labeler Information

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

Labeler Name: Silver Star Brands
Labeler Code: 68703
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: 10-01-2019 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: 12-31-2021 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.

Good Night Sleep Product Label Images

Good Night Sleep 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

Hpus Active Ingredients

HPUS Active Ingredients: Equal volumes of each ingrediet in 10X, 30X, 1LM potencies. Aconitum nap, Aesculus hipp, flos, Avena, Cocculus, Coffea cruda, Hysocyamus, Ignatia, Passiflora, Pusatilla nutt, Staphysag, Valeriana.

Uses*

Uses*: Temporarily relieves symptoms of occasional sleeplessness.
*This statement has not been evaluated by the food and Drug Administration. This product is not inteded to diagnose, treat, cure or prevent any disease.

Warnings

If symptoms persist or worsen, consult a healthcare professional.
If pregnant or breastfeeding, ask a healthcare professional before use.
Keep this and all medication out of reach of children.

Directions

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and Children 12+: 3 sprays, 3 times per day. Children 2-12: 2 sprays, 3 times per day. Use additionally as needed, up to 6 times per day.

Other Safety Information

Contains no artificial flavors or colorants. No gluten added.Tamper resistant for your protection. use only if saftey seal is intact.

Inactive Ingredients

Inactive Ingredients: Purified water, carya ovata bark extract (hickory), citrust extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Inactive Ingredients: Purified water, carya ovata bark extract (hickory), citrust extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Otc - Keep Out Of Reach Of Children

Keep this and all medication out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Purpose

Temporarily relieves symptoms of occasional sleeplessness

* Please review the disclaimer below.