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NDC 63868-0938-16 Mineral oil 100 mg/100mL Details

Mineral oil 100 mg/100mL

Mineral oil is a ORAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is MINERAL OIL.

Product Information

NDC	63868-0938
Product ID	63868-938_ca3086e8-2446-49e4-9816-997ef2e4f9fe
Associated GPIs	46400010001700
GCN Sequence Number	002997
GCN Sequence Number Description	mineral oil OIL ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09020
HICL Sequence Number	001319
HICL Sequence Number Description	MINERAL OIL
Brand/Generic	Generic
Proprietary Name	Mineral oil
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral oil
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/100mL
Substance Name	MINERAL OIL
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 63868-0938-16 (63868093816)

Pricing Information
NDC Package Code	63868-938-16
Billing NDC	63868093816
Package	473 mL in 1 BOTTLE (63868-938-16)
Marketing Start Date	2014-07-31
NDC Exclude Flag	N
Price Per Unit	0.00562
Pricing Unit	ML
Effective Date	2022-08-17
NDC Description	QC MINERAL OIL HEAVY
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-08-17

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b53b68de-e2b6-4c8b-b486-2e8aba32a9b6 Details

Active ingredient

Mineral oil 100%

Purpose

intestinal lubricant

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 8 hours

Warnings

Do not use

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

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

do not take with meals
take only at bedtime

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

keep tightly closes
protect from sunlight

Inactive ingredients

d-alpha tocopherol (Vitamin E) as stabilizer

Questions or comments?

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

Principal Display Panel

Mineral Oil

Lubricant Laxative

Odorless

Tasteless

Colorless

FL OZ (mL)

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

248-449-9300

Package Label

Quality Choice Mineral Oil

INGREDIENTS AND APPEARANCE

MINERAL OIL

mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-938
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	100 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-938-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2014	05/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/31/2014	05/30/2025

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 11/2022

Document Id: ca3086e8-2446-49e4-9816-997ef2e4f9fe

Set id: b53b68de-e2b6-4c8b-b486-2e8aba32a9b6

Version: 5

Effective Time: 20221104