FDA.reportPublic FDA data

Mineral Oil

Manufacturer
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Effective date
2025-04-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:59:18

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 daily dose or in divided doses adults and children 12 years of age and over: oral dosage is a minimum single dose of 15 mL to a maximum daily dose of 45 mL children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL children under 6 years of age: consult a doctor 

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil, USP 100%

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 - DO NOT USE SECTION

  • in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for longer than 1 week

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

When using this product

OTC - WHEN USING SECTION

  • do not take with meals
  • take only at bedtime

Stop use and ask a doctor if you have

OTC - STOP USE SECTION

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or 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 (1-800-222-1222) 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: oral dosage is a minimum single dose of 15 mL to a maximum daily dose of 45 mL
  • children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL
  • children under 6 years of age: consult a doctor 

Other Information

SPL UNCLASSIFIED SECTION

  • keep tightly closed
  • protect from direct light

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Vitamin E as stabilizer

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFETY SEALED

Mineral Oil

Lubricant Laxative

Odorless-Tasteless

Crystal Clear

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

www.mygnp.com

Questions or comments? Call 1-877-753-3935

Monday-Friday 9AM-5PM EST

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY Mineral OilGOOD NEIGHBOR PHARMACY Mineral Oil 

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-395-16Mineral Oil473 mL in 1 BOTTLE, PLASTICOIL4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-395MINERAL OIL OIL [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]8Current NDC, Legacy NDC, 1 package rows20250418_581f81a0-7488-4c90-b33e-06c6301a4fd2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-395-16ML - Milliliter46122-395289f1dd6-2d78-420a-ba77-1e442dd824ff12019-03-12

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
46122-39546122-395-16

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

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 OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
ndc (package): 46122-395-16
ndc (product): 46122-395
ndc11 (package): 46122039516
spl id: 3fff7ff5-b86e-4d83-a612-623e245ecd97
spl set id: 581f81a0-7488-4c90-b33e-06c6301a4fd2

Reported adverse events (FAERS/openFDA)#

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