FDA.reportPublic FDA data

Fleet

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2021-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:52

Label at a glance#

ProductFleet
Active ingredientSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC
Label structure13 sections

Dosage and administration

Single   Daily   Dosage:   Do   not   use   more   unless   directed   by   a   doctor.   See   Warnings. Adults and children 12 years and over       One Bottle Children 2 to 11 years       Use Fleet Enema for Children Children under 2 years       DO NOT USE

Label contents#

Full prescribing information#

Active Ingredient (in each 118-mL delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Monobasic Sodium Phosphate 19 g      

Dibasic Sodium Phosphate 7 g      

Purpose

OTC - PURPOSE SECTION

Laxative / Bowel Cleanser

Laxative / Bowel Cleanser

Use

INDICATIONS & USAGE SECTION

For relief of occasional constipation or bowel cleansing before rectal examinations.

Warnings

WARNINGS SECTION

Using more than one enema in 24 hours can be harmful.

Ask a doctor before using this product if you

OTC - ASK DOCTOR SECTION

  • are on a sodium-restricted diet
  • have kidney diseaseare pregnant or nursing a baby

Ask a doctor before using any laxative if you:

OTC - ASK DOCTOR SECTION

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

Stop using this product and consult a doctor if you

OTC - STOP USE SECTION

  • have rectal bleeding
  • have no bowel movement after the enema is given These symptoms may indicate a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or accidental ingestion, get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Single Daily Dosage: Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years and over       One Bottle

Children 2 to 11 years       Use Fleet Enema for Children

Children under 2 years       DO NOT USE

Other Information

OTHER SAFETY INFORMATION

Sodium Content 4.4 g

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

Questions?

OTC - QUESTIONS SECTION

C.B. Fleet Co., Inc. Lynchburg, VA 24502 U.S.A.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fleet
ready-to use
enema
133 mL

PRINCIPAL DISPLAY PANEL Fleet ready-to use enema 133 mLPRINCIPAL DISPLAY PANEL Fleet ready-to use enema 133 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN2
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD2
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY2
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0132-0553-402021-11-10C16284748780-19d75b9d1-26f7-f424-e053-dadaa90a57ceFleet Enema Adult Australia 0132-0553-40
0132-0553-402020-01-31C16284748780-19d75b9d1-26f7-f424-e053-dadaa90a57ceFleet Enema Adult Australia 0132-0553-40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0553-40Fleet133 mL in 1 BOTTLE, WITH APPLICATORENEMA1332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0553FLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]21 package rows20211112_2d4f908a-85b1-49d6-85cf-e44556b87c4c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-05530132-0553-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWACTIB
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZETHONIUM CHLORIDEPH41D05744IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6895efc0-18e6-4304-8dc2-86632631bdcc2d4f908a-85b1-49d6-85cf-e44556b87c4c2021-11-15WarningsExact identifier
spl id: 6895efc0-18e6-4304-8dc2-86632631bdcc
spl set id: 2d4f908a-85b1-49d6-85cf-e44556b87c4c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.