NDC 0132-0079 Fleet
Glycerin Suppository Rectal

Product Information

Product Code0132-0079
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.
Fleet
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.
Glycerin
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.
  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.
  • 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.
C.b. Fleet Company, Inc.
Labeler Code0132
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.
part334
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
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.
11-01-1984
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
04-30-2023
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

Usage Information


Product Packages

NDC 0132-0079-00

Package Description: 100 SUPPOSITORY in 1 JAR

NDC 0132-0079-12

Package Description: 12 SUPPOSITORY in 1 JAR

Price per Unit: $0.08064 per EA

NDC 0132-0079-24

Package Description: 24 SUPPOSITORY in 1 JAR

Price per Unit: $0.08064 per EA

NDC 0132-0079-50

Package Description: 50 SUPPOSITORY in 1 JAR

Price per Unit: $0.08064 per EA

Product Details

Fleet is a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Fleet is glycerin. The product's dosage form is suppository and is administered via rectal form.


What are Fleet 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.

  • ALOE (UNII: V5VD430YW9)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • STEARIC ACID (UNII: 4ELV7Z65AP)


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.

Fleet 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



Active Ingredient



Glycerin 2 g


Purpose



Hyperosmotic Laxative


Uses



  • for relief of occasional constipation
  • this product usually produces bowel movement in 1/4 to 1 hour

Warnings



For rectal use only

May cause rectal discomfort or a burning sensation.


Ask A Doctor Before Using Any Laxative If You Have



  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Stop Use And Consult A Doctor If You Have



  • rectal bleeding
  • no bowel movement within 1 hour of using this product
  • These symptoms may indicate a serious condition.


Keep Out Of Reach Of Children To Prevent Accidental Ingestion.



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


Directions



Single Daily Dosage (per 24 hours)

adults and children 6 years and over1 suppository, or as directed by a doctor
children 2 to under 6 yearsuse Fleet® Pedia-Lax Suppositories®
children under 2 yearsask a doctor

Insert suppository well up into rectum. To product laxative action suppository is designed to dissolve only partially, which may not be noticeable.


Other Information



  • Store container tightly closed.
  • Keep away from excessive heat.
  • Mouth of jar sealed for safety. If foil imprinted with green Fleet® emblem is missing or torn, do not use.

Inactive Ingredients



aloe vera gel (decolorized), edetate disodium, purified water, sodium hydroxide, stearic acid


Questions?



1-866-255-6960


Principal Display Panel



Fleet Glycerin Suppositories

24 suppositories


* Please review the disclaimer below.