FDA.reportPublic FDA data

Mineral Oil

Manufacturer
Safecor Health, LLC
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:40

Label at a glance#

ProductMineral Oil
Active ingredientMINERAL OIL
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil USP

Purpose

OTC - PURPOSE SECTION

Lubricant Laxative

Use:

INDICATIONS & USAGE SECTION

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

WARNINGS:

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use * 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.

OTC - WHEN USING SECTION

When using this product: Do not take with meals. Take only at bedtime.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If breast feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.

DOSAGE & ADMINISTRATION SECTION

Directions: * 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 mL to 45 mL), maximum 3 Tablespoons (45 mL) in 24 hours
Children 6 to under 12 years of age 1 to 3 teaspoons (5 mL to 15 mL), maximum 3 teaspoons (15 mL) in 24 hours
Children under 6 years Do not use. Consult a doctor

OTHER SAFETY INFORMATION

Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Mixed tocopherols (added as a stabilizer)

NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204
Rev: 05/2019 PN5471

Principal Display Panel - Lid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 30 mL

NDC 48433-202-30

Mineral Oil USP

Lubricant Laxative

DO NOT TAKE WITH MEALS

348433202302

Pkg By: Safecor Health, LLC

Columbus, OH 43204

Principal Display Panel - Lid Label
Principal Display Panel - Lid Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
343017mineral oil 100 % Oral SolutionPSN3
343017mineral oil 1000 MG/ML Oral SolutionSCD3
343017mineral oil 100 % Oral SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48433-202-302022-01-30C16284748780-1d6a99b39-8513-a426-e053-dadaa90af4c2SAFECOR HEALTH Mineral Oil USP 30 mL Unit Dose Drug Facts
48433-202-302022-01-28C16284748780-1d6a99b39-8513-a426-e053-dadaa90af4c2SAFECOR HEALTH Mineral Oil USP 30 mL Unit Dose Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-202-30Mineral Oil30 mL in 1 CUP, UNIT-DOSESOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-202MINERAL OIL SOLUTION [SAFECOR HEALTH, LLC]3Current NDC, Legacy NDC, 1 package rows20250110_ef182484-692e-4eb3-bcf1-3c990ec0d08e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-202-30ML - Milliliter48433-20212bff3ec-94d8-4d44-ad4f-fa1c310a35b512019-10-07

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
48433-20248433-202-30

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
MINERAL OILT5L8T28FGPACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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 OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
ndc (package): 48433-202-30
ndc (product): 48433-202
ndc11 (package): 48433020230
spl id: 3d4d61f6-fa20-4a72-b7fd-2fdeb0709f5d
spl set id: ef182484-692e-4eb3-bcf1-3c990ec0d08e

Reported adverse events (FAERS/openFDA)#

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