Drugplain

Mineral oil 100 mg/100mL

Mineral oil · OIL · EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

10 Recalls on Record
Plain English

Mineral oil is an over-the-counter oral lubricant laxative that helps relieve constipation by softening stool and making bowel movements easier. It works by coating the intestines and stool to retain moisture.

Key Facts

Brand Name
Mineral oil
Generic Name
Mineral oil
NDC Code (Product)
49035-035
Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Strength
100 mg/100mL
Dosage Form
OIL
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
10/31/2014

Recall History

10 Recalls on Record
Class II09/11/2024

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

OngoingVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II01/30/2024

Brassica Pharma Pvt Ltd

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II08/24/2015

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

TerminatedVoluntary: Firm initiated
Class II09/16/2024

AbbVie Inc.

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

OngoingVoluntary: Firm initiated
Class I02/24/2023

Global Pharma Healthcare Private Limited

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

OngoingVoluntary: Firm initiated
Class II01/30/2024

Brassica Pharma Pvt Ltd

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II01/30/2024

Brassica Pharma Pvt Ltd

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II08/24/2015

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

TerminatedVoluntary: Firm initiated
Class II09/16/2024

AbbVie Inc.

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use141 reports
drug ineffective139 reports
pyrexia138 reports
fatigue136 reports
headache125 reports
pain123 reports
rash118 reports
nausea117 reports
pulmonary embolism109 reports
cardiac murmur105 reports

Frequently Asked Questions

What is Mineral oil used for?

Mineral oil is an over-the-counter oral lubricant laxative that helps relieve constipation by softening stool and making bowel movements easier. It works by coating the intestines and stool to retain moisture.

Is Mineral oil a controlled substance?

Mineral oil is not classified as a controlled substance by the DEA.

What is the generic name for Mineral oil?

The generic name for Mineral oil is Mineral oil. There are 12 other brand versions of Mineral oil.

What is the NDC code for Mineral oil 100 mg/100mL?

The NDC (National Drug Code) for Mineral oil 100 mg/100mL is 49035-035, listed by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC).