Sleepcalm Pellet
NDC 0220-9308

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0220-9308?
  5. Sleepcalm Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

Sleepcalm (matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Boiron. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white pellet for oral administration. This product entry covers the primary NDC 0220-9308 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0220-9308
Proprietary Name:
Sleepcalm
Non-Proprietary Name: [1]
Matricaria Chamomilla Whole, Gelsemium Sempervirens Root, Hyoscyamus Niger, Potassium Bromide, Passiflora Incarnata Flowering Top, Datura Stramonium
Substance Name: [2]
Gelsemium Sempervirens Root; Potassium Bromide; Hyoscyamus Niger; Passiflora Incarnata Flowering Top; Matricaria Chamomilla Whole; Datura Stramonium
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Boiron
Labeler Code:
0220
Product Label ID:
de0b458d-5f0a-78f4-e053-2995a90afe4b
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
05-02-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
4 MM

Code Structure Chart

Product Details

What is NDC 0220-9308?

The NDC code 0220-9308 is assigned by the FDA to the product Sleepcalm. It is commonly known by its generic name, matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium. This pharmaceutical product is labeled by Boiron and is currently categorized as listed product. The medication is a pellet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0220-9308-42. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Uses*temporarily relieves symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as:restless sleepintermittent awakeningirritability nightmaresnight terrorsreduces time to fall asleep if your child has difficulty falling asleep

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q)
  • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (Active Moiety)
  • POTASSIUM BROMIDE (UNII: OSD78555ZM)
  • BROMIDE ION (UNII: 952902IX06) (Active Moiety)
  • HYOSCYAMUS NIGER (UNII: 4WRK2153H3)
  • HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (Active Moiety)
  • PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O)
  • PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (Active Moiety)
  • DATURA STRAMONIUM (UNII: G6W4F0V8Z3)
  • DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (Active Moiety)
  • MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
  • MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

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

Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".