Sunmark Mineral Oil

Manufacturer: Strategic Sourcing Services | Natureplex LLC
Effective date: 2025-01-14
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:52:55

Label at a glance#

ProductSunmark Mineral Oil Laxative

Active ingredientMineral Oil

Label structure11 sections

Dosage and administration

Single daily dosage Do not use more unless directed by a doctor. See Warnings . Adults and children 12 years old and over 1 bottle Children 2 to under 12 years old 1/2 bottle once daily Children under 2 years DO NOT USE

Storage and handling

store at 15 to 30°C (59 to 86°F) this product generally produces a bowel movement in 1-5 minutes carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.

Contacts and useful links#

PhonePoison Help800-222-1222

PhoneLabel contact866-323-0107

Websitewww.natureplex.com

www.natureplex.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 118 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

Warnings

WARNINGS SECTION

For rectal use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

abdominal pain, nausea, or vomiting
a sudden change in bowel habits lasting more than 2 weeks
already used a laxative for more than 1 week

OTC - STOP USE SECTION

Stop use and ask a doctor if you have:

rectal bleeding
no bowel movement after use

These symptoms may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

DOSAGE & ADMINISTRATION SECTION

Single daily dosage

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years old and over	1 bottle
Children 2 to under 12 years old	1/2 bottle once daily
Children under 2 years	DO NOT USE

Other information

STORAGE AND HANDLING SECTION

store at 15 to 30°C (59 to 86°F)
this product generally produces a bowel movement in 1-5 minutes
carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

Distributed By Strategic Sourcing Services LLC
6555 State Highway 161, Irwing, TX 75039

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark^®

COMPARE TO FLEET^®
MINERAL OIL ENEMA
ACTIVE INGREDIENT*

NDC 49348-185-20

complete
ready-to-use

enema

Mineral Oil

Sodium free lubricant
laxative for relief of
occasional constipation

Comfortable,
lubricated tip

Works in minutes

NOT MADE WITH
NATURAL RUBBER
LATEX

4.5 FL OZ
(133 ml)

Principal Display Panel - 133 ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
205121	mineral oil 100 % Enema	PSN	5
205121	mineral oil 1000 MG/ML Enema	SCD	5
205121	mineral oil 100 % Enema	SY	5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-185-20	Sunmark Mineral OilLaxative	1 in 1 CARTON	ENEMA	1		5
49348-185-20	Sunmark Mineral OilLaxative	133 mL in 1 BOTTLE	ENEMA	133		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-185	SUNMARK MINERAL OIL LAXATIVE (MINERAL OIL) ENEMA [STRATEGIC SOURCING SERVICES]	5	Current NDC, Legacy NDC, 2 package rows	20250117_c54f7df2-3845-425f-b13e-3dc000123f3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-185-20	ML - Milliliter	49348-185	dbbce4c4-e389-4c66-a02b-e754431205a3	1	2016-12-07

Products#

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

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

Sunmark Mineral Oil Laxative
Mineral Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-185	49348-185-20

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
Name	UNII	Kind
Mineral Oil	T5L8T28FGP	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunmark Mineral Oil Laxative	MINERAL OIL	Strategic Sourcing Services	c54f7df2-3845-425f-b13e-3dc000123f3c	2025-01-14	Warnings	Exact identifier ndc (package): 49348-185-20 ndc (product): 49348-185 ndc11 (package): 49348018520 spl id: fdbfcdfe-c67a-4aa5-9dc5-f4bd11a51a53 spl set id: c54f7df2-3845-425f-b13e-3dc000123f3c

Reported adverse events (FAERS/openFDA)#

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