FLEET

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-05-31 23:57:32

Label at a glance#

ProductFLEET
Active ingredientMINERAL OIL
Label structure10 sections

Indications and uses

for relief of fecal impaction for relief of occasional constipation for removal of residue after barium administration This product usually produces a bowel movement in 2 to 15 minutes.

Dosage and administration

Single Daily Dosage (per 24 hours) adults and children 12 years and over 1 bottle per day children 2 to under 12 years one-half bottle children under 2 years DO NOT USE

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 118 mL delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 100%

Purpose

OTC - PURPOSE SECTION

Lubricant laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of fecal impaction
  • for relief of occasional constipation
  • for removal of residue after barium administration

This product usually produces a bowel movement in 2 to 15 minutes.

Warnings

WARNINGS SECTION

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask a doctor before using this product if you

OTC - ASK DOCTOR SECTION

  • have a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Stop use and ask a doctor if you have

OTC - STOP USE SECTION

  • rectal bleeding
  • no bowel movement within 15 minutes of using this product

These symptoms may indicate a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Single Daily Dosage (per 24 hours)

adults and children
12 years and over
1 bottle per day
children
2 to under 12 years
one-half bottle
children
under 2 years
DO NOT USE

Other information

OTHER SAFETY INFORMATION

  • sodium-free

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fleet®
Laxative

Mineral Oil enema
lubricant laxative
1 bottle - 4.5 FL OZ (133 mL)

Fleet® Laxative Mineral Oil enema lubricant laxative 1 bottle - 4.5 FL OZ (133 mL)Fleet® Laxative Mineral Oil enema lubricant laxative 1 bottle - 4.5 FL OZ (133 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205121mineral oil 100 % EnemaPSN14
205121mineral oil 1000 MG/ML EnemaSCD14
205121mineral oil 100 % EnemaSY14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0301-40FLEET133 mL in 1 BOTTLE, WITH APPLICATORENEMA13314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0301FLEET (MINERAL OIL) ENEMA [C.B. FLEET COMPANY, INC.]14Current NDC, Legacy NDC, 1 package rows20231025_2528cb5e-437e-41f0-9c34-e9ce57404d8b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0301-40ML - Milliliter0132-0301ddd6b765-e996-404e-96e9-5abb457fe06412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGP8
Mineral OilACTIVE MOIETYT5L8T28FGP8

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-03010132-0301-40

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB

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
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
ndc (package): 0132-0301-40
ndc (product): 0132-0301
ndc11 (package): 00132030140
spl id: 749b7e47-7344-44ec-a526-0c7dc18680f2
spl set id: 2528cb5e-437e-41f0-9c34-e9ce57404d8b

Reported adverse events (FAERS/openFDA)#

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