Mineral oil

Manufacturer: QUALITY CHOICE (Chain Drug Marketing Association)
Effective date: 2022-11-04
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 21:49:40

Label at a glance#

ProductMineral oil

Active ingredientMINERAL OIL

Label structure10 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 age dose adults & children over 12 years 1 to 3 tablespoons (15 to 45 mL) children under 12 years consult a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

PhoneLabel contact248-449-9300

Websitewww.qualitychoice.com

www.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 100%

Purpose

OTC - PURPOSE SECTION

intestinal lubricant

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

if you have difficulty swallowing
in children under 12 years of age
if you are pregnant
for a period longer than 1 week
if you are bedridden or aged

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

stomach reflux
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

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 ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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

age	dose
adults & children over 12 years	1 to 3 tablespoons (15 to 45 mL)
children under 12 years	consult a doctor

Other information

SPL UNCLASSIFIED SECTION

keep tightly closes
protect from sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

d-alpha tocopherol (Vitamin E) as stabilizer

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral Oil

Lubricant Laxative

Odorless

Tasteless

Colorless

FL OZ (mL)

Distributed by C.D.M.A Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

248-449-9300

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-938	MINERAL OIL OIL [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	5	Legacy NDC	20221105_b53b68de-e2b6-4c8b-b486-2e8aba32a9b6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-938-16	ML - Milliliter	63868-938	96508fd8-4f9e-4ebf-88f4-799b03e181c6	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	2
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Mineral oil
TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-938	63868-938-16

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
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	ACTIB
TOCOPHEROL	R0ZB2556P8	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Match
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA	Exact identifier — unii candidate 5 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ca3086e8-2446-49e4-9816-997ef2e4f9fe			b53b68de-e2b6-4c8b-b486-2e8aba32a9b6	2022-11-04	Warnings	Exact identifier spl id: ca3086e8-2446-49e4-9816-997ef2e4f9fe spl set id: b53b68de-e2b6-4c8b-b486-2e8aba32a9b6

Reported adverse events (FAERS/openFDA)#

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