FDA.reportPublic FDA data

Mineral oil

Manufacturer
GERITREX LLC | Calumet Penreco LLC
Effective date
2017-08-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:52:19

Label at a glance#

ProductMineral oil
Active ingredientMINERAL OIL
Label structure9 sections

Storage and handling

Store at room temperature 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

WARNINGS SECTION

Dosage wanring: Using more than one enema in 24 hours can be harmful

​Caution: For rectal use only

Ask a doctor before using laxative if you:

OTC - ASK DOCTOR SECTION

  • Have nausea, vomiting, or abdominal pain
  • Have suddent change in bowel habits lasting more than two weeks
  • Have already used a laxative for more than 1 week


​Ask a doctor of pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

​When using this product, do not use more than directed.

OTC - WHEN USING SECTION

Serious side effects may occur from excess dosage.

​Stop using this product and consult a doctor if you:

OTC - STOP USE SECTION

  • Have rectal bleeding
  • Have no bowel movemenet after the enema is given

These symptoms may indicated a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

​If pregnant or breastfeeding​ ​ ​Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN
In the case of accidental ingestion contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Remove orange protective shield before inserting by holding bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove, then insert lubricated tip into rectum and squeeze gently.

STORAGE AND HANDLING SECTION

Store at room temperature 59°-86°F (15°-30°C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130354162175053GTIN-13: 0354162175053
EAN-13: 0354162175053
GTIN-12: 354162175053
UPC-A: 354162175053
GTIN storage (14 digits): 00354162175053		Clean Copy - Mineral Oil Enema 4.5-LABEL PROOF-1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-175-052020-09-27C16284748780-1ab0e2407-2fed-f274-e053-dbdaa90a6471Mineral Oil Enema
54162-175-122020-09-27C16284748780-1ab0e2407-2fed-f274-e053-dbdaa90a6471Mineral Oil Enema
54162-175-052020-09-25C16284748780-1ab0e2407-2fed-f274-e053-dbdaa90a6471Mineral Oil Enema
54162-175-122020-09-25C16284748780-1ab0e2407-2fed-f274-e053-dbdaa90a6471Mineral Oil Enema
54162-175-052020-07-22C16284748780-1ab0e2407-2fed-f274-e053-dbdaa90a6471Mineral Oil Enema
54162-175-122020-07-22C16284748780-1ab0e2407-2fed-f274-e053-dbdaa90a6471Mineral Oil Enema

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-175-05Mineral oil113 g in 1 BOTTLE, WITH APPLICATOROIL1133
54162-175-12Mineral oil113 g in 1 BOTTLE, WITH APPLICATOROIL1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-175MINERAL OIL OIL [GERITREX LLC]3Legacy NDC, 2 package rows20170828_2d035d8f-9914-4378-b976-aa0d851caa3a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-175-05ML - Milliliter54162-175fb46ed83-bfce-42fe-83ff-74a07b0ba22512014-08-01
54162-175-12ML - Milliliter54162-175e322e3d8-ea10-48c4-92d8-6b65160a1fa812016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
VITAMIN DINACTIVE INGREDIENT9VU1KI44GP1

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
54162-17554162-175-05, 54162-175-12

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
VITAMIN D9VU1KI44GPIACT

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
e37fe39a-b729-4e3c-9f79-e1f50f6c74d42d035d8f-9914-4378-b976-aa0d851caa3a2017-08-28WarningsExact identifier
spl id: e37fe39a-b729-4e3c-9f79-e1f50f6c74d4
spl set id: 2d035d8f-9914-4378-b976-aa0d851caa3a

Reported adverse events (FAERS/openFDA)#

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