FDA.reportPublic FDA data

Mineral Oil

Manufacturer
Strategic Sourcing Services LLC | Nice-Pak Products, LLC
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:46:17

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#

ADVERSE REACTIONS SECTION

Distributed by: McKesson Corp. Via Strategic Sourcing Services LLC.

Memphis, TN 38141 

Money Back Guarantee

www.fosterandthrive.com

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)

SPL UNCLASSIFIED SECTION

© 2023 McKesson Corporation

You may report serious side effects to 833-358-6431

Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70677-1110-1

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

Foster & Thrive™

Mineral Oil

LUBRICANT LAXATIVE

Odorless Tasteless Colorless

For Relief of:

  • Occasional Constipation

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0021047BAmm02.jpg
Data codeData MatrixL0021047FAmm01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1110-1Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1110-1ML - Milliliter70677-1110519f12be-8cdd-44b8-99ed-439a4ac6ce5f12023-09-05

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
70677-111070677-1110-1

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
MINERAL OILT5L8T28FGPACTIB
TOCOPHEROLR0ZB2556P8IACT

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 OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
ndc (package): 70677-1110-1
ndc (product): 70677-1110
ndc11 (package): 70677111001
spl id: 4b0a7266-a1ff-f97f-e063-6294a90a497b
spl set id: e4965086-dcc0-4b34-bb30-81facf7139f3

Reported adverse events (FAERS/openFDA)#

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