FDA.reportPublic FDA data

LEADER Mineral Oil

Product NDC
70000-0448
11-digit product format
700000448
Labeler code
70000
Product ID
70000-0448_3afc6408-65d9-be10-e063-6294a90aeb04
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
LIQUID
Route
ORAL
Labeler
Cardinal Health, 110 dba Leader
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-18
Marketing end
2027-02-28
Substance
MINERAL OIL
Active strength
1000 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

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

Additional Listing Data#

Finished product
Yes
Brand name base
LEADER Mineral Oil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL1000 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP
Rxcui343017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0448-1LEADER Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0448-1ML - Milliliter70000-0448b156330a-ea44-4e87-85fc-dc551674419912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0448LEADER MINERAL OIL (MINERAL OIL) LIQUID [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20231223_7d4f8fa3-8203-5523-e053-2991aa0aba1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
343017mineral oil 100 % Oral SolutionPSN7d4f8fa3-8203-5523-e053-2991aa0aba1a6
343017mineral oil 1000 MG/ML Oral SolutionSCD7d4f8fa3-8203-5523-e053-2991aa0aba1a6
343017mineral oil 100 % Oral SolutionSY7d4f8fa3-8203-5523-e053-2991aa0aba1a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0448-170000044801473 mL in 1 BOTTLE, PLASTIC (70000-0448-1) 473 ml2018-12-182027-02-28NoNoCurrent