LEADER Mineral Oil

Manufacturer: Cardinal Health, 110 dba Leader | Pharma Nobis, LLC
Effective date: 2025-07-28
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:08:46

Label at a glance#

ProductLEADER Mineral Oil

Active ingredientMINERAL OIL

Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil

OTC - PURPOSE SECTION

Lubricant Laxative

INDICATIONS & USAGE SECTION

For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.

WARNINGS SECTION

Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative

OTC - ASK DOCTOR SECTION

Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

OTC - STOP USE SECTION

and consult a doctor if there is a fialure to have a bowel movement after use.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime.

Children under 6 yrs of age: Consult a doctor before use

INACTIVE INGREDIENT SECTION

dl-alpha-tocopherol as a preservative

OTHER SAFETY INFORMATION

Keep tightly closed and protected from direct light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mineraloil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
343017	mineral oil 100 % Oral Solution	PSN	6
343017	mineral oil 1000 MG/ML Oral Solution	SCD	6
343017	mineral oil 100 % Oral Solution	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0448-1	LEADER Mineral Oil	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0448-1	ML - Milliliter	70000-0448	b156330a-ea44-4e87-85fc-dc5516744199	1	2019-08-06

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

LEADER Mineral Oil
Mineral Oil
.ALPHA.-TOCOPHEROL ACETATE, DL-

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0448	70000-0448-1

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
Name	UNII	Kind
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
MINERAL OIL	T5L8T28FGP	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER Mineral Oil	MINERAL OIL	Cardinal Health, 110 dba Leader	7d4f8fa3-8203-5523-e053-2991aa0aba1a	2025-07-28	Warnings	Exact identifier ndc (package): 70000-0448-1 ndc (product): 70000-0448 ndc11 (package): 70000044801 spl id: 3afc6408-65d9-be10-e063-6294a90aeb04 spl set id: 7d4f8fa3-8203-5523-e053-2991aa0aba1a

Reported adverse events (FAERS/openFDA)#

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