FDA.reportPublic FDA data

Mineral Oil

Manufacturer
Better Living Brands, LLC | Nice-Pak Products, LLC
Effective date
2026-02-24
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:47:14

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

Storage and handling

keep tightly closed.  Protect from sunlight.

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

STORAGE AND HANDLING SECTION

keep tightly closed.  Protect from sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mixed tocopherols (added as a stabilizer)

Questions?

OTC - QUESTIONS SECTION

Call 1-888-723-3929

Adverse reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009     1-888-723-3929

www.betterlivingbrandsLLC.com

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

Signature Care  ™

NDC 21130-831-43

Quality Guaranteed

Mineral Oil USP

LUBRICANT LAXATIVE

  • Tasteless, Odorless, Colorless
  • Generally effective within 6-8 hours

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 SolutionPSN10
705909mineral oil 999 MG/ML Oral SolutionSCD10
705909mineral oil 99.9 % Oral SolutionSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130321130780700GTIN-13: 0321130780700
EAN-13: 0321130780700
GTIN-12: 321130780700
UPC-A: 321130780700
GTIN storage (14 digits): 00321130780700		mm02.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-831-432024-04-18C16284748780-1d6a99b39-73c7-a426-e053-dadaa90af4c2Signature Care 831.000/831AA Mineral Oil
21130-831-432022-01-28C16284748780-1d6a99b39-73c7-a426-e053-dadaa90af4c2Signature Care 831.000/831AA Mineral Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-831-43Mineral Oil473 mL in 1 BOTTLE, PLASTICLIQUID47310

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
21130-83121130-831-43

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
TOCOPHEROLR0ZB2556P8IACT
MINERAL OILT5L8T28FGPACTIB

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
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact 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
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii+route
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact 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 OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
ndc (package): 21130-831-43
ndc (product): 21130-831
ndc11 (package): 21130083143
spl id: 4b92e29d-b8ec-ed74-e063-6294a90ae2f4
spl set id: 7f2f1b30-497a-4c53-accc-8455169b17b3

Reported adverse events (FAERS/openFDA)#

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