FDA.reportPublic FDA data

Enema Mineral Oil

Manufacturer
Natureplex LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:49:54

Label at a glance#

ProductEnema Mineral Oil
Active ingredientMineral Oil
Label structure10 sections

Dosage and administration

Rectal enema dosage is 120 ml in a single daily dosage (per 24 hours). Adults & children 13 years old and older 1 bottle Children under 13 years old DO NOT USE

Storage and handling

Store at 15 to 30°C (59 to 86°F). Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 120 ml delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 100%

Purpose

OTC - PURPOSE SECTION

Lubricant laxative

Use

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.

Caution

SPL UNCLASSIFIED SECTION

To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.

Do not use

OTC - DO NOT USE SECTION

  • on children under 13 years of age
  • on pregnant women
  • on persons with difficulty swallowing
  • on bedridden patients
  • if you are presently taking a stool softener laxative
  • or take with meals

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have already used a laxative for more than 3 days
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits that persist over a period of 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions (or as directed by a doctor)

DOSAGE & ADMINISTRATION SECTION

Rectal enema dosage is 120 ml in a single daily dosage (per 24 hours).

Adults & children 13 years old and older1 bottle
Children under 13 years oldDO NOT USE

Other information

STORAGE AND HANDLING SECTION

  • Store at 15 to 30°C (59 to 86°F).
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive ingredient

INACTIVE INGREDIENT SECTION

None

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare To Fleet® Mineral Oil Enema

Natureplex™

READY TO USE

Enema

Mineral
Oil

Sodium
Free

For
Relief Of
Occasional
Constipation

Not Made
With
Natural
Rubber
Latex

Soft,
Easy To
Use
Bottle

NDC 67234-019-01

1
Bottle
4.5 Fl Oz
(133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205121mineral oil 100 % EnemaPSN5
205121mineral oil 1000 MG/ML EnemaSCD5
205121mineral oil 100 % EnemaSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-019-01Enema Mineral Oil133 mL in 1 BOTTLE, WITH APPLICATORENEMA1335
67234-019-01Enema Mineral Oil1 in 1 CARTONENEMA15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-019ENEMA MINERAL OIL (MINERAL OIL) ENEMA [NATUREPLEX LLC]5Legacy NDC, 2 package rows20250101_44ded8db-cace-416a-a15f-921fcdaa11bd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGP1
Mineral OilACTIVE MOIETYT5L8T28FGP1

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
67234-01967234-019-01

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
ad5f3dc7-8904-4d8f-b99c-0abd129046f844ded8db-cace-416a-a15f-921fcdaa11bd2024-12-31WarningsExact identifier
spl id: ad5f3dc7-8904-4d8f-b99c-0abd129046f8
spl set id: 44ded8db-cace-416a-a15f-921fcdaa11bd

Reported adverse events (FAERS/openFDA)#

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