FDA.reportPublic FDA data

Mineral Oil

Manufacturer
Kesin Pharma Corporation
Effective date
2025-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:20

Label at a glance#

ProductMineral Oil
Active ingredientMINERAL OIL
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours

Dosage and administration

do not take with meals take only at bedtime may be taken as a single dose or as directed by a doctor Age Dose 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.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Mineral Oil (100%)

Lubricant Laxative

INACTIVE INGREDIENT SECTION

There are no other inactive ingredients.

Purpose

OTC - PURPOSE SECTION

Lubricant Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours

Warnings

WARNINGS SECTION

Do not use

OTC - KEEP OUT OF REACH OF CHILDREN 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

Ask a doctor before use

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 persists over a period of 2 weeks

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • 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

OTC - WHEN USING SECTION

When using this product

  • do not take with meals
  • take only at bedtime

Stop use and ask a doctor

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.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 dose or as directed by a doctor
AgeDose
adults and children 12 years of age and over1 to 3 Tablespoons (15 mL to 45 mL)
maximum 3 Tablespoons (45 mL) in 24 hours
children 6 to under 12 years of age1 to 3 teaspoons (5 mL to 15 mL)
maximum 3 teaspoons (15 mL) in 24 hours
children under 6 yearsdo not use. consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • store at 20°C to 25°C (68°F to 77°F)
  • protect from direct light
  • NDC 81033-042-30: 30 mL unit dose cup
  • NDC 81033-042-50: Carton containing 50 - 30 mL unit dose cups

Questions or comments ?

OTC - QUESTIONS SECTION

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Packaged by:
Kesin Pharma
Oldsmar, FL 34677

Rev. 03/2025

Kesin LogoKesin Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-042-50

Mineral Oil, USP 30 mL

Delivers 30 mL

FOR INSTITUTIONAL ONLY

50 x 30 mL Unit Dose Cups

Store at 68ºF to 77ºF (20ºC to 25ºC)

NDC 81033-042-50 Mineral Oil 30 mL Carton LabelNDC 81033-042-50 Mineral Oil 30 mL Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
343017mineral oil 100 % Oral SolutionPSN1
343017mineral oil 1000 MG/ML Oral SolutionSCD1
343017mineral oil 100 % Oral SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-042-30Mineral Oil30 mL in 1 CUP, UNIT-DOSESOLUTION301
81033-042-50Mineral Oil50 in 1 CARTONSOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-042MINERAL OIL SOLUTION [KESIN PHARMA CORPORATION]1Current NDC, 2 package rows20250321_30a11cc9-e407-23b7-e063-6294a90a7d6e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-042-30ML - Milliliter81033-042f0f21268-ce5c-4392-a927-75b9ade2ada212025-05-14
81033-042-50ML - Milliliter81033-0421c6d783f-55d6-4b91-9855-4721bcf9318d12025-05-14
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 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81033-04281033-042-30, 81033-042-50
48433-202

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
ndc (package): 81033-042-50
ndc (package): 81033-042-30
ndc (product): 81033-042
ndc11 (package): 81033004230
ndc11 (package): 81033004250
spl id: 30a11cc9-e408-23b7-e063-6294a90a7d6e
spl set id: 30a11cc9-e407-23b7-e063-6294a90a7d6e
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
ndc (product): 48433-202

Reported adverse events (FAERS/openFDA)#

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