NDC 68784-101 Hemorrhoidal
Cocoa Butter, Phenylephrine Hydrochloride Suppository Rectal

Product Information

Product Code68784-101
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.
Hemorrhoidal
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.
Cocoa Butter, 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.
Acino Products, Llc.
Labeler Code68784
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.
04-29-2021
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.
12-31-2022
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

Usage Information


Product Packages

NDC 68784-101-12

Package Description: 12 BLISTER PACK in 1 BOX > 1 SUPPOSITORY in 1 BLISTER PACK

NDC 68784-101-24

Package Description: 24 BLISTER PACK in 1 BOX > 1 SUPPOSITORY in 1 BLISTER PACK

Product Details

Hemorrhoidal is a human over the counter drug product labeled by Acino Products, Llc.. The generic name of Hemorrhoidal is cocoa butter, phenylephrine hydrochloride. The product's dosage form is suppository and is administered via rectal form.


What are Hemorrhoidal Active Ingredients?

The following is the list of active ingredients in 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.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STARCH, CORN (UNII: O8232NY3SJ)


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.

Hemorrhoidal Labeling and Warnings

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.

Table of Contents



Drug Facts Active Ingredients



Active Ingredients
(per suppository)

Cocoa butter 88.44 %
Phenylephrine hydrochloride 0.25 %


Purpose



Protectant
Vasoconstructor


Keep Out Of Reach Of Children.



Keep out of reach of children.

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


Uses



  • temporarily shrinks hemorrhoidal tissues
  • gives temporary relief to th itching, burning and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas

Warnings



For rectal use only


Ask A Doctor Or Pharmacist Before Use If You Are



presently taking a prescription drug for high blood pressure or depression


Ask A Doctor Before Use If You Have



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

When Using This Product



  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

If Pregnant Or Breast-Feeding



ask a health professional before use.


Directions Adults



  • detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
  • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement. Children under 12 years of age: consult doctor

Other Information



Store at room temperature or in a cool place but not over 80° F


Inactive Ingredients



methylparaben, propylparaben, starch


Hemorrhoidal Suppositories Label



HEMORRHOIDAL SUPPOSITORIES

12 SUPPOSITORIES

NDC68784-101-12

*Compare to the active ingredient in PREPARATION H®

Acino Products

Hemorrhoidal Suppositories

HELPS REDUCE INFLAMMATION AND SWELLING OF HEMORRHOIDAL TISSUES
PROVIDES TEMPORARY RELIEF IN MANY CASES

12 SUPPOSITORIES

Tamper-evident: for your safety, suppositories are packed in tamper-evident sealed wrapper. Do not use if wrapper is torn or open.

Easy Open

Manufactured by:
Acino Products, LLC
Hamilton, NJ 08691
MADE IN USA

*This product is not manufactured or distributed by Pfizer Consumer Healthcare., distributor of Preparation H®.



* Please review the disclaimer below.