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Leader Ready to Use Mineral Oil Laxative 118 g/118mL Enema — NDC 70000-0109-01 package photo

Leader Ready to Use Mineral Oil Laxative 118 g/118mL Enema

by Cardinal Health · 1 BOTTLE in 1 CARTON (70000-0109-1) / 133 mL in 1 BOTTLE
NDC 70000-0109-01
🏷️ FDA NDC (as labeled) 70000-0109-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70000-0109-1
Product NDC 70000-0109
11-digit billing NDC 70000010901
NCPDP billing unit ML — per mL (volume)
RxCUI 205121
UNII T5L8T28FGP
Application # M007
SPL Set ID b8494d02-8a7d-47b4-80b0-b8ab51b625fd
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-02-19
Marketing end 2026-11-30
Route RECTAL
Dosage form ENEMA
Substance MINERAL OIL
GPI-14 46400010005110
GPI class Enema Mineral Oil
GCN Seq No 002996
GCN 09049
HICL code 001319
Ingredient (HICL) Mineral Oil
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3S
Therapeutic class — specific (HIC3) Laxatives, Local/Rectal
AHFS code 56:12.00.00
AHFS class Cathartics And Laxatives
FDB label name READY TO USE MINERAL OIL ENEMA
FDB brand name Ready To Use Enema
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0109-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70000-0109-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Softeners, emollients class.

Drug family (ATC) Softeners, emollients
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCardinal Health
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedFeb 2013
Product typeHuman Otc Drug
Portfolio84 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name READY TO USE MINERAL OIL ENEMA Ingredient Mineral Oil
📗 Our plain-language guide HelloPharmacist
  • That depends on how you take it. If you use a rectal enema, you can expect a bowel movement in about 2 to 15 minutes. If you take the oral liquid, it generally takes 6 to 8 hours —...
  • How long does it take mineral oil to work?
  • You need to be careful here. Mineral oil can change how other drugs are absorbed into your body. The general rule is to take mineral oil at least 2 hours before or after any other...
  • Can I take mineral oil with my other medications?
📖 Read our full Mineral Oil guide →
7
Nutrient depletion considerations

Mineral Oil may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Mineral Oil nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

From the label’s inactive-ingredient sectionnone

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.014 $1.90 / 133 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Nov 2021 Sep 2022 Oct 2022 Aug 2023 $0.014 $0.013
▲ Up 12% over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunmark Mineral Oil Laxative 118 g/118mL 49348-0185-20 Strategic 1 bottle $0.014 — Availability likely save 2%
Foster and Thrive Ready to Use Mineral oil Laxative 1000 g/118mL 70677-1090-01 Strategic 1 bottle $0.014 — Availability likely save 2%
HealthMart Mineral Oil Single Laxative 118 g/118mL 62011-0270-01 Strategic 1 bottle $0.014 — FDA listed —
Leader Ready to Use Mineral Oil Laxative 118 g/118mLthis 70000-0109-01 Cardinal 1 bottle $0.014 — FDA listed —
Fleet 100 g/100mL 00132-0301-40 C.B. 133 ml $0.017 — Availability likely +19%
Pure and Gentle 100 g/100mL 53329-0013-11 Medline 1 bottle — — FDA listed —
4718 Enema, Mineral Oil 133 g/133mL 67777-0430-01 Dynarex 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
On the market since
Feb 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Leader Ready to Use Mineral Oil Laxative (this brand).

Top reported reactions

Pyrexia142
Fatigue137
Headache127
Pain125
Rash121
Nausea117
Pulmonary Embolism112

Age at onset

Neonate1
Child2
Adolescent4
Adult100
Elderly145

Reporter sex

1,146 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization557
Death160
Life-threatening65
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 132 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0109-01 You're viewing this 1 BOTTLE in 1 CARTON (70000-0109-1) / 133 mL in 1 BOTTLE 2013-02-19 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 18 words ▾

Uses for relief of occasional constipation for relief of fecal impaction for removal of residue after barium administration

⏱️ Dosage and Administration 38 words ▾

Directions Single daily dose (per 24 hours). adults & children 12 years and over 1 bottle once daily children 2 to under 12 years 1/2 bottle once daily discard unused portion children under 2 years DO NOT USE

⚠️ Warnings 132 words ▾

Warnings For rectal use only Ask a doctor before use if you have abdominal pain, nausea, or vomiting if you have a sudden change in bowel habits that persists over a period of 2 weeks if you have already used a laxative for more than 1 week if constipation continues after one week of use, contact your doctor Stop use and ask a doctor if you have rectal bleeding or no bowel movement within 15 minutes of using this product you need to use a laxative for more than one week These symptoms may indicate a serious condition.

If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

📦 Storage and Handling 18 words ▾

Other information store at 15°-30°C (59°-86°F) this product generally produces a bowel movement in 2 to 15 minutes

🧪 Active Ingredient 11 words ▾

Active ingredient (in each 118 mL delivered dose) Mineral oil 100%

🧪 Inactive Ingredients 3 words ▾

Inactive ingredients none

🎯 Purpose 3 words ▾

Purpose Lubricant laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0108-01 · Cardinal 70000-0112-01 · Cardinal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.