FDA.reportPublic FDA data

Mineral Oil

Manufacturer
United Natural Foods, Inc. dba UNFI | Nice-Pak Products, LLC
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:46:14

Label at a glance#

ProductMineral Oil
Active ingredientMINERAL OIL
Label structure16 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

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.

Do not use

WARNINGS SECTION

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

OTC - STOP USE SECTION

if 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

SPL UNCLASSIFIED SECTION

keep tightly closed.  Protect from sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mixed tocopherols (added as a stabilizer)

Questions or comments?

OTC - QUESTIONS SECTION

1-877-932-7948

Adverse reactions

ADVERSE REACTIONS SECTION

Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA

Contact us at 1-877-932-7498, or www.supervalu-ourownbrands.com

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41163-831-43

EQUALINE ®

mineral oil USP

lubricant laxative

for relief of occasional constipation

  • odorless
  • tasteless
  • colorless

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (473 mL)

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
705909mineral oil 99.9 % Oral SolutionPSN17
705909mineral oil 999 MG/ML Oral SolutionSCD17
705909mineral oil 99.9 % Oral SolutionSY17

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041163251359GTIN-13: 0041163251359
EAN-13: 0041163251359
GTIN-12: 041163251359
UPC-A: 041163251359
GTIN storage (14 digits): 00041163251359		mm02.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-831-43Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID47317

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81

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
41163-83141163-831-43

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 · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates

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 OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
ndc (package): 41163-831-43
ndc (product): 41163-831
ndc11 (package): 41163083143
spl id: 4b093c55-ee57-5b4e-e063-6294a90a8aab
spl set id: cb7bc571-295f-47c2-ae93-18cba194752c

Reported adverse events (FAERS/openFDA)#

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