Fissure Control Solution/ Drops
NDC 51393-6334
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Fissure Control (calendula officinalis flowering top and hamamelis virginiana root bark/stem bark) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Forces Of Nature. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a blue solution/ drops for topical administration. This product entry covers the primary NDC 51393-6334 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
51393-6334
Proprietary Name:
Fissure Control
Non-Proprietary Name: [1]
Calendula Officinalis Flowering Top And Hamamelis Virginiana Root Bark/stem Bark
Substance Name: [2]
Calendula Officinalis Flowering Top; Hamamelis Virginiana Root Bark/stem Bark
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Solution/ Drops
- A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
51393
Product Label ID:
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Marketing Timeline
Start Marketing Date: [9]
04-06-2011
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
BLUE (C48333)
Code Structure Chart
Product Details
What is NDC 51393-6334?
The NDC code 51393-6334 is assigned by the FDA to the product Fissure Control. It is commonly known by its generic name, calendula officinalis flowering top and hamamelis virginiana root bark/stem bark. This pharmaceutical product is labeled by Forces Of Nature and is currently categorized as listed product. The medication is a solution/ drops administered via topical route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 51393-6334-1, 51393-6334-3, 51393-6334-5. 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?
For the relief of inflammation, pain, itching and redness associated with hemorrhoids/fissures. Symptoms of fissures include an anal tear, pain during or after bowel movements, blood in the stool.
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:
- CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
- CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (Active Moiety)
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (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:
- CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
- LAVANDIN OIL (UNII: 9RES347CKG)
- SESAME OIL (UNII: QX10HYY4QV)
- HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
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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".
