0132-0201 NDC - FLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC)

Drug Information

Product NDC: 0132-0201

Proprietary Name: Fleet

Non Proprietary Name: sodium phosphate, dibasic and sodium phosphate, monobasic

Active Ingredient(s):
  • 7 g/230mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE;
  • 19 g/230mL SODIUM PHOSPHATE, MONOBASIC


Administration Route(s): RECTAL

Dosage Form(s): ENEMA

Pharmacy Class(es):
  • Increased Large Intestinal Motility [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC]

Labeler Information

Labeler Name: C.B. Fleet Company, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: part334
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:6/25/2004

Package Information

No. Package Code Package Description Billing Unit
10132-0201-10230 mL in 1 BOTTLE, WITH APPLICATOR (0132-0201-10)ML
20132-0201-40133 mL in 1 BOTTLE, WITH APPLICATOR (0132-0201-40)ML
30132-0201-42133 mL in 1 BOTTLE, WITH APPLICATOR (0132-0201-42)ML
40132-0201-45133 mL in 1 BOTTLE, WITH APPLICATOR (0132-0201-45)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0132-0201The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEFleetThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEsodium phosphate, dibasic and sodium phosphate, monobasicThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEENEMAThe translation of the dosage form Code submitted by the firm.
ROUTE NAMERECTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/10/1953This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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.
APPLICATION NUMBERpart334This 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.
LABELER NAMEC.B. Fleet Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASICAn 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.
ACTIVE NUMERATOR STRENGTH7; 19 
ACTIVE INGRED UNITg/133mL; g/133mL 
PRODUCT NDC0132-0201The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEFleetThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEsodium phosphate, dibasic and sodium phosphate, monobasicThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEENEMAThe translation of the dosage form Code submitted by the firm.
ROUTE NAMERECTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/25/2004This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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.
APPLICATION NUMBERpart334This 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.
LABELER NAMEC.B. Fleet Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASICAn 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.
ACTIVE NUMERATOR STRENGTH7; 19 
ACTIVE INGRED UNITg/230mL; g/230mL 

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This page was last updated on: 2/1/2023