FDA.reportPublic FDA data

FLEET

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:40

Label at a glance#

ProductFLEET
Active ingredientMINERAL OIL
Label structure10 sections

Indications and uses

▪ relieves occasional constipation ▪ generally produces bowel movement in 6 to 8 hours

Dosage and administration

▪ do not take with meals ▪ shake well before using ▪ adults and children 12 years of age and over: 3 to 9 teaspoons  (15 - 45 mL), maximum 9 teaspoons (45 mL) in 24 hours ▪ children 6 to under 12 years of age: 1 to 3 teaspoons (5 – 15 mL), maximum 3 teaspoons (15 mL) in 24 hours or as directed by a doctor ▪ children under 6 years of age: consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL/teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 2.5 mL.......................................

Purpose

OTC - PURPOSE SECTION

Lubricant Laxative

Uses

INDICATIONS & USAGE SECTION

▪ relieves occasional constipation

▪ generally produces bowel movement in 6 to 8 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

▪ for children under 6 years of age, pregnant women, bedridden patients or persons with difficulty swallowing

Ask a doctor before using this product if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

▪ abdominal pain, nausea or vomiting

▪ a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a stool softener laxative.

When using this product

OTC - WHEN USING SECTION

do not take with meals.

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪ you notice rectal bleeding or fail to have a bowel movement after use of a laxative. This may indicate a serious condition. Discontinue use and consult a doctor.

▪ you need to use the product more than one week

If 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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

▪ do not take with meals

▪ shake well before using

▪ adults and children 12 years of age and over: 3 to 9 teaspoons  (15 - 45 mL), maximum 9 teaspoons (45 mL) in 24 hours

▪ children 6 to under 12 years of age: 1 to 3 teaspoons (5 – 15 mL), maximum 3 teaspoons (15 mL) in 24 hours or as directed by a doctor

▪ children under 6 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, benzoic acid, carrageenan (irish moss), ethyl vanillin, glycerin, mapliene triple oil, purified water, titanium dioxide, vanillin

Other information

OTHER SAFETY INFORMATION

Store at room temperature 15°-25°C (59°-77°F)

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-855-727- 4277

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fleet ®  
Laxative
Mineral Oil
Oral Liquid
Lubricant Laxative

16 FL OZ (480 mL)

Fleet ® Laxative Mineral Oil Oral Liquid Lubricant Laxative 16 FL OZ (480 mL)Fleet ® Laxative Mineral Oil Oral Liquid Lubricant Laxative 16 FL OZ (480 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489229mineral oil 2.5 mL in 5 mL Oral SuspensionPSN1
1489229mineral oil 0.5 ML/ML Oral SuspensionSCD1
1489229mineral oil 2.5 ML per 5 ML Oral SuspensionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0400-48FLEET480 mL in 1 BOTTLELIQUID4801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0400FLEET (MINERAL OIL) LIQUID [C.B. FLEET COMPANY, INC.]1Current NDC, 1 package rows20240405_e0b7acab-add4-4daf-b1df-bb7cf5ca8e19.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-04000132-0400-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
ACACIA5C5403N26OIACT
BENZOIC ACID8SKN0B0MIMIACT
CARRAGEENAN5C69YCD2YJIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
VANILLINCHI530446XIACT

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.e0b7acab-add4-4daf-b1df-bb7cf5ca8e192024-04-01WarningsExact identifier
ndc (package): 0132-0400-48
ndc (product): 0132-0400
ndc11 (package): 00132040048
spl id: be2908e5-b58b-4d3c-b284-ee31cf2f088d
spl set id: e0b7acab-add4-4daf-b1df-bb7cf5ca8e19

Reported adverse events (FAERS/openFDA)#

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