FDA.reportPublic FDA data

Mineral Oil

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | Nice-Pak Products, LLC
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:35:56

Label at a glance#

ProductMineral Oil
Active ingredientMINERAL OIL
Label structure17 sections

Dosage and administration

do not take with meals  take only at bedtime may be taken as a single daily dose or in divided doses adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours children under 6 years of age - do not use, consult a doctor

Storage and handling

keep tightly closed. Protect from sunlight. 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 99.9% 

Purpose

OTC - PURPOSE SECTION

Lubricant laxative

Use

INDICATIONS & USAGE SECTION

for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.

Warnings

WARNINGS SECTION

for this product

Do not use

OTC - DO NOT USE SECTION

  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than 1 week
  • if you are bedridden or aged

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea, or vomiting
  • noticed 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
  • taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

OTC - WHEN USING SECTION

do not take with meals. Take only at bedtime.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

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 
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other Information

STORAGE AND HANDLING SECTION

keep tightly closed. Protect from sunlight. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

mixed tocopherols (added as a stabilizer)

Questions?

OTC - QUESTIONS SECTION

1-888-593-0593

Adverse reaction

ADVERSE REACTIONS SECTION

DIST. BY CAH DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

LEADER™

NDC 70000-0663-1

Mineral Oil

Lubricant Laxative

For relief of occasional constipation

100% Money back Guarantee

Odorless Tasteless, Colorless

16 FL OZ (1 PT) 473 mL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
705909mineral oil 99.9 % Oral SolutionPSN4
705909mineral oil 999 MG/ML Oral SolutionSCD4
705909mineral oil 99.9 % Oral SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0663-1Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0663-1ML - Milliliter70000-066396d1ca7e-8edb-42da-bb0d-6ad31078e8c612025-06-13

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
70000-066370000-0663-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
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
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsExact identifier
ndc (package): 70000-0663-1
ndc (product): 70000-0663
ndc11 (package): 70000066301
spl id: 498e8e9b-8f82-0c6e-e063-6294a90ae3e0
spl set id: 803f444f-d136-4f06-9842-24a71a3d7d6b

Reported adverse events (FAERS/openFDA)#

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