FDA.reportPublic FDA data

4718 Enema, Mineral Oil

Manufacturer
Dynarex
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:26

Label at a glance#

Product4718 Enema, Mineral Oil
Active ingredientMINERAL OIL
Label structure8 sections

Indications and uses

For relief of occasional constipation. This product generally produces bowel movement in 2 to 15 minutes.

Dosage and administration

Adults and children 12 years old and older: 1 bottle daily. Children from 2 to under 12 years of age: 1/2 bottle once daily. Children under 2 years old: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 100%

Purpose

OTC - PURPOSE SECTION

Lubricant Laxative

Uses

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation.
  • This product generally produces bowel movement in 2 to 15 minutes.

Warnings

WARNINGS SECTION

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

  • Laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.
  • Longer than one week unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • Noticed a sudden change in bowel habits that persists over a period of two weeks.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You have rectal bleeding or fail to have a bowel movement after use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years old and older: 1 bottle daily.
  • Children from 2 to under 12 years of age: 1/2 bottle once daily.
  • Children under 2 years old: Consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature.

Questions?

OTC - QUESTIONS SECTION

  • 1-888-Dynarex

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4718 Enema Box Label4718 Enema Box LabelEnema, Mineral Oil, 4718

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205121mineral oil 100 % EnemaPSN3
205121mineral oil 1000 MG/ML EnemaSCD3
205121mineral oil 100 % EnemaSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-430-014718 Enema, Mineral Oil48 in 1 CASEENEMA483
67777-430-024718 Enema, Mineral Oil133 mL in 1 BOTTLEENEMA1333
67777-430-024718 Enema, Mineral Oil1 in 1 BOXENEMA13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-4304718 ENEMA, MINERAL OIL ENEMA [DYNAREX]3Current NDC, Legacy NDC, 3 package rows20241122_9e51c852-9477-5cf5-e053-2a95a90a97db.zip

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
67777-43067777-430-02, 67777-430-01

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
ndc (package): 67777-430-02
ndc (package): 67777-430-01
ndc (product): 67777-430
ndc11 (package): 67777043002
ndc11 (package): 67777043001
spl id: 27596c71-a1ec-2f3c-e063-6394a90a8d6d
spl set id: 9e51c852-9477-5cf5-e053-2a95a90a97db

Reported adverse events (FAERS/openFDA)#

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