Homeopathic Moon Drops Lozenge
NDC 57556-008

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57556-008?
  5. Homeopathic Moon Drops Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Homeopathic Moon Drops (arsenic cation 30x, matricaria chamomilla 6x, arabica coffee bean 12x, gelsemium sempervirens root 12x, strychnos ignatii seed 30x, lycopodium clavatum spore 30x, sodium chloride 30x, strychnos nux vomica seed 30x, valerian 12c,) is a UNAPPROVED DRUG OTHER-approved product labeled by Historical Remedies Llp. This medication is typically used as a allergens [cs]. It is supplied as a white lozenge for oral administration. This product entry covers the primary NDC 57556-008 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
57556-008
Proprietary Name:
Homeopathic Moon Drops
Non-Proprietary Name: [1]
Arsenic Cation 30x, Matricaria Chamomilla 6x, Arabica Coffee Bean 12x, Gelsemium Sempervirens Root 12x, Strychnos Ignatii Seed 30x, Lycopodium Clavatum Spore 30x, Sodium Chloride 30x, Strychnos Nux Vomica Seed 30x, Valerian 12c,
Substance Name: [2]
Arabica Coffee Bean; Arsenic Trioxide; Gelsemium Sempervirens Root; Lycopodium Clavatum Spore; Matricaria Chamomilla Whole; Sodium Chloride; Strychnos Ignatii Seed; Strychnos Nux-vomica Seed; Valerian
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Historical Remedies Llp
Labeler Code:
57556
Product Label ID:
0e7972a5-a930-4a52-8896-02ce810fa90b
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
05-01-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
14 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 57556-008?

The NDC code 57556-008 is assigned by the FDA to the product Homeopathic Moon Drops. It is commonly known by its generic name, arsenic cation 30x, matricaria chamomilla 6x, arabica coffee bean 12x, gelsemium sempervirens root 12x, strychnos ignatii seed 30x, lycopodium clavatum spore 30x, sodium chloride 30x, strychnos nux vomica seed 30x, valerian 12c, . This pharmaceutical product is labeled by Historical Remedies Llp and is currently categorized as listed product. The medication is a lozenge administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 57556-008-01. 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?

Adults and children over 8: Dissolve one Moon Drops lozenge in mouth. Repeat every half hour as needed.

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:

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".