Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
LEADER Mineral Oil 1000 mg/mL Liquid, 473 mL — NDC 70000-0448-1 (Billing 70000-0448-01)
by Cardinal Health, 110 dba Leader · 473 mL in 1 BOTTLE, PLASTIC
This is a package of 473 mL of LEADER Mineral Oil 1000 mg/mL Liquid from Cardinal Health, 110 dba Leader, marketed since Dec 2018 and currently FDA-listed, this package's marketing is listed to end Feb 2027; retail pharmacies pay about $0.0105 per mL (NADAC). It is this product's only package size.
NDC 70000-0448-01
🏷️ FDA NDC (as labeled)
70000-0448-1
billing pads the package segment with a zero
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 70000-0448-1 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 70000 labeler · 0448 product · 1 package
- Package marketed since
- Dec 18, 2018
- Package marketing ended
- Feb 28, 2027
- Sample package
- No — commercial package
- Billing quantity
- 473 mL per package
- Barcode (UPC-A, from the NDC)
- 3 7000004481 7
- Medicaid fills, this package
- 107 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
70000-0448-1
Product NDC
70000-0448
11-digit billing NDC
70000044801
NCPDP billing unit
ML — per mL (volume)
RxCUI
343017
UNII
T5L8T28FGP
Application #
M007
SPL Set ID
7d4f8fa3-8203-5523-e053-2991aa0aba1a
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2018-12-18
Marketing end
2027-02-28
Route
ORAL
Dosage form
LIQUID
Substance
MINERAL OIL
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
46400010001700
GPI class
Mineral Oil
GCN Seq No
002997
GCN
09020
HICL code
001319
Ingredient (HICL)
Mineral Oil
HIC1 code
D
Therapeutic class — broad (HIC1)
Biliary System/Gastro-Intestinal System
HIC2 code
D6
Therapeutic class — intermediate (HIC2)
Drugs Acting Principally On The Colon
HIC3 code
D6S
Therapeutic class — specific (HIC3)
Laxatives And Cathartics
AHFS code
56:12.00.00
AHFS class
Cathartics And Laxatives
FDB label name
MINERAL OIL
FDB brand name
Mineral Oil
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 002997
- GCN: 09020
- GPI-14 (Medi-Span): 46400010001700
- HICL (First Databank): 001319
- AHFS class code: 56:12.00.00
- RxCUI (RxNorm): 343017
Why two NDCs?
The FDA registers this code as 70000-0448-1 — 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 → 70000-0448-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name MINERAL OIL Ingredient Mineral Oil
📗 Our plain-language guide HelloPharmacist
- Mostly for occasional constipation, by mouth or as an enema. Some enemas are also used for fecal impaction or to clear residue after a barium test. One topical product is used for...
- Take it only at bedtime and not with meals. It usually works in about 6 to 8 hours. An enema usually works within 2 to 15 minutes.
- Space it out. Take mineral oil 2 or more hours before or after other drugs, since laxatives may affect how they work. Tell me if you take a stool softener.
- Not longer than 1 week. If constipation continues or your bowel habits suddenly change for 2 weeks, see your doctor.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mineral Oil — tap one for details:
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.
BETA-CAROTENE
Insignificant Depletion
PHOSPHATE SALTS
Insignificant Depletion
VITAMIN A
Insignificant Depletion
VITAMIN D
Insignificant Depletion
VITAMIN E
Insignificant Depletion
+2 more
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Mineral Oil?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.011 | $4.97 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.2139 | $101.17 / 473 ml |
| 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
▲ Up 88% over the last 8 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.
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70000-0448-01 You're viewing this Main listing | 473 mL in 1 BOTTLE, PLASTIC | 2018-12-18 | Feb 28, 2027 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mineral Oil 100 mg/100mL 46122-0395-16 | AmerisourceBergen | 473 ml | $0.010 | — | Availability likely | save 5% |
| LEADER Mineral Oil 1000 mg/mLthis 70000-0448-01 | Cardinal | 473 ml | $0.010 | — | FDA listed | — |
| oil 1 mg/mL 00869-0831-43 | Vi-Jon, | 473 ml | — | — | FDA listed | — |
| Mineral Oil 1000 mg/mL 48433-0202-30 | Safecor | 30 ml | — | — | FDA listed | — |
| Mineral oil 100 mg/100mL 49580-0334-06 | P | 473 ml | — | — | FDA listed | — |
| CVS Mineral Oil 1000 mg/mL 69842-0238-16 | CVS | 473 ml | — | — | FDA listed | — |
| Mineral Oil 1000 mg/mL 81033-0042-50 | Kesin | 50 cups | — | — | FDA listed | — |
| Humco Mineral Oil Heavy 1000 mg/mL 00395-1685-28 | Humco | 3800 ml | — | — | FDA listed | — |
| Mineral Oil Heavy 1000 mg/mL 82645-0906-16 | Pharma | 473 ml | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
Availability & generic status
🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Mineral Oil inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII WR1WPI7EW8
A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
1 inactive ingredient listed in the exact product block matched to this NDC.
The official label also statesdl-alpha-tocopherol as a preservative
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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.
Manufacturer & labeler
LabelerCardinal Health, 110 dba Leader
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedDec 2018
Product typeHuman Otc Drug
Portfolio34 products on file
More NDCs from Cardinal Health, 110 dba Leader labeler code 70000
- Glycerin 1 g Suppository NDC 70000-0429-1
- Leader Extra Strength Antacid Calcium carbonate 750 mg Tablet, Chewable NDC 70000-0430-2
- Leader Extra Strength Antacid Calcium carbonate 750 mg Tablet, Chewable NDC 70000-0431-1
- Leader Gas relief Simethicone 80 mg Tablet, Chewable NDC 70000-0434-1
- Leader Ultra Strength Antacid Calcium carbonate 1000 mg Tablet, Chewable NDC 70000-0436-1
- Laxative Sennosides 15 mg Tablet, Sugar Coated NDC 70000-0443-1
- Leader Advanced Relief Eye Drops DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCl 70 100 mg/100mL; 400 1000 mg/100mL; 1000 mg/100mL; 50 mg/100mL Solution/ Drops NDC 70000-0456-1
- Leader Ultra Lubricating Eye Drops Polyethylene glycol 400, propylene 400 .4 g/100mL; .3 g/100mL Solution/ Drops NDC 70000-0457-1
- Sore Throat Relief Cherry Flavor Phenol 1.4 g/100mL Spray NDC 70000-0458-1
- LEADER Ultra Strength Peppermint Flavor Chewable Antacid Tablets 1000 mg Tablet, Chewable NDC 70000-0459-1
- Leader Extra Strength Sugar Free Antacid 750 mg Tablet, Chewable NDC 70000-0460-1
- Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE 2 mg Capsule, Liquid Filled NDC 70000-0461-1
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Ask a Doctor Before Use If
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Other Information
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.
⏱️ Dosage and Administration ▾
Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime. Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime. Children under 6 yrs of age: Consult a doctor before use
⚠️ 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, if you are presently taking a stool softener laxative
🧪 Active Ingredient ▾
Mineral Oil
🧪 Inactive Ingredients ▾
dl-alpha-tocopherol as a preservative
🎯 Purpose ▾
Lubricant Laxative
📄 Ask a Doctor Before Use If ▾
Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.
📄 Stop Use and Ask a Doctor If ▾
and consult a doctor if there is a fialure to have a bowel movement after use.
📄 Keep Out of Reach of Children ▾
In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.
📄 Other Information ▾
Keep tightly closed and protected from direct light
📄 Package Label / Principal Display Panel ▾
mineraloil
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
107
Units reimbursed last 4 qtrs
10.7K
Gross reimbursed last 4 qtrs
$2.3K
Avg / prescription
$21.45
Avg / unit
$0.2139
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$0.2139
gross reimbursed
vs
NADAC / mL
$0.0105
acquisition cost
=
Spread
+$0.2034
+1937% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 107 Rx
State Medicaid map
Units reimbursed · per 100k residents
32.855.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
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.