NDC 72959-005 Rectibiom Hemorrhoid Relief
Rectibiom Suppositories Suppository Rectal

Product Information

What is NDC 72959-005?

The NDC code 72959-005 is assigned by the FDA to the product Rectibiom Hemorrhoid Relief which is a human over the counter drug product labeled by Biom Pharmaceutical Corporation. The generic name of Rectibiom Hemorrhoid Relief is rectibiom suppositories. 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 72959-005-01 15 suppository in 1 box . 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 Code72959-005
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.		Rectibiom Hemorrhoid Relief
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.		Rectibiom Suppositories
Substance Name 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.		Hard Fat; Phenylephrine Hydrochloride
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.		Biom Pharmaceutical Corporation
Labeler Code72959
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		part346
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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
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.		03-15-2023
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.		12-31-2024
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 Rectibiom Hemorrhoid Relief?


Product Packages

NDC Code 72959-005-01

Package Description: 15 SUPPOSITORY in 1 BOX

Product Details

What are Rectibiom Hemorrhoid Relief 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.

Rectibiom Hemorrhoid Relief Active Ingredients UNII Codes

Rectibiom Hemorrhoid Relief 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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Rectibiom Hemorrhoid Relief 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



Active Ingredients




Phenylephrine HCI, 0.25%

Hard Fat, 88.44%


Purpose



protectant

vasoconstrictor

protectant


Uses



  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily relieves burning and shrinks hemorrhoidal tissue.
  • Temporarily provide a coating for relief of anorectal discomforts.
  • Temporarily protects the inflammed, irritated anorectal surface to  help make bowel movements less painful.

Warnings



For rectal use only.


Ask A Doctor Before Use If You Have



  • heart disease
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes

Ask A Doctor Or Pharmacist Before Use If You Are



presently taking a prescription drug for high blood pressure or depression.


When Using This Product



do not exceed the recommended daily dosage.


Stop Use And Ask A Doctor If



  • you experience bleeding
  • condition worsens or does not improve within 7 days.

    • These may be signs of a serious condition.


If Pregnant Or Breastfeeding



 ask a health professional before use.


Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adults:

  • When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product.
  • Detach one suppository from strip
  • Remove wrapper before inserting into rectum
  • Hold suppository with rounded end up and insert tip of fingernail at end marked "peel down"
  • Carefully peel film slowly and evenly down both sides to expose suppository
  • Insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement

    • Children under 12 years:  ask a doctor


Storage



Store  at 20-250C(68-770C)


Inactive Ingredients



Silica gel, Hyaluronic acid, olive oil, Shea Butter, sesame seed oil, Probiotics(Lactobacillus reuteri, Lactobacillus Rhamnosus)


Otc - Questions



Call Weekdays 9 AM to 5PM est at +1941-552-8417


Box Information - 15 Count



image description - RectiBiom Hemorrhoid Relief

image description - RectiBiom Hemorrhoid Relief


* Please review the disclaimer below.