NDC 48951-8115 Quercus Borago Adult Size
Suppository Rectal

Product Information

What is NDC 48951-8115?

The NDC code 48951-8115 is assigned by the FDA to the product Quercus Borago Adult Size which is a human over the counter drug product labeled by Uriel Pharmacy Inc.. The product's dosage form is suppository and is administered via rectal form. The product is distributed in a single package with assigned NDC code 48951-8115-1 10 blister pack in 1 box / 2 g in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code48951-8115
Proprietary Name 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.
Quercus Borago Adult Size
Non-Proprietary Name 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.
Quercus Borago Adult Size
Product Type 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.
Human Otc Drug
Dosage FormSuppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Rectal - Administration to the rectum.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Uriel Pharmacy Inc.
Labeler Code48951
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-01-2009
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Quercus Borago Adult Size?


Product Packages

NDC Code 48951-8115-1

Package Description: 10 BLISTER PACK in 1 BOX / 2 g in 1 BLISTER PACK

Product Details

What are Quercus Borago Adult Size Active Ingredients?

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.

Quercus Borago Adult Size Active Ingredients UNII Codes

Quercus Borago Adult Size Inactive Ingredients 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.

* Please review the disclaimer below.

Quercus Borago Adult Size Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Indications & Usage



Directions: FOR RECTAL USE


Dosage & Administration



Insert 1 suppository as needed.


Otc - Active Ingredient



Active Ingredients: 100g contains: 5g Aesculus (Horse chestnut) 3X, 5g Borago (Borage) 3X, 5g Carduus mar. (Milk thistle) 3X, 5g Hamamelis (Witch hazel) 3X; Quercus (Oak) 1X, Mercurialis per. (Dog’s mercury) 2X, Stibium met. (Antimony) 3X


Inactive Ingredient



Inactive Ingredients: Cocoa butter, Hydrogenated vegetable oil, Micronized silica gel


Otc - Purpose



Use: Temporary relief of hemorrhoid symptoms.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.


Warnings



KEEP REFRIGERATED OR STORE IN COOL, DRY PLACE. REFRIGERATE TO RESOLIDIFY. Warnings: Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seals on box are broken or missing.


Otc - Questions



Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com


* Please review the disclaimer below.