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Mineral Oil 999 mg/mL Liquid, 473 mL — NDC 70000-0663-1 (Billing 70000-0663-01)

by CARDINAL HEALTH 110, LLC. DBA LEADER · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Mineral Oil 999 mg/mL Liquid from CARDINAL HEALTH 110, LLC. DBA LEADER, marketed since Apr 2023 and currently FDA-listed; retail pharmacies pay about $0.0099 per mL (NADAC). It is this product's only package size.

NDC 70000-0663-01
🏷️ FDA NDC (as labeled) 70000-0663-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 70000-0663-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0663 product · 1 package
Package marketed since
Apr 17, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
473 mL per package
Barcode (UPC-A, from the NDC)
3 7000006631 4
Medicaid fills, this package
93 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) 70000-0663-1
Product NDC 70000-0663
11-digit billing NDC 70000066301
NCPDP billing unit ML — per mL (volume)
RxCUI 705909
UNII T5L8T28FGP
Application # M007
SPL Set ID 803f444f-d136-4f06-9842-24a71a3d7d6b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-17
Route ORAL
Dosage form LIQUID
Substance MINERAL OIL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 46400010001700
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): 705909
Why two NDCs? The FDA registers this code as 70000-0663-1 — 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 → 70000-0663-01. 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.

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.
📖 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.

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 $0.010 $4.68 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0671 $31.74 / 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
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.010 $0.007
▲ Up 19% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70000-0663-01 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2023-04-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mineral Oil 999 mg/mLthis 70000-0663-01 CARDINAL 473 ml $0.010 — Availability likely —
Mineral Oil 999 mg/mL 70677-1110-01 Strategic 473 ml $0.010 — Availability likely —
Mineral Oil 999 mg/mL 00363-0831-43 Walgreen 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 11344-0831-43 Nice-Pak 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 11673-0831-43 Target 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 17856-1110-01 ATLANTIC 50 cups — — FDA listed —
Mineral Oil 999 mg/mL 21130-0831-43 Better 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 36800-0931-43 Topco 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 41163-0831-43 United 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 41250-0831-43 Meijer, 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 50804-0831-43 Perrigo 473 ml — — FDA listed —
Mineral oil 999 mg/mL 51316-0831-43 CVS 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 55301-0831-43 Your 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 55910-0831-43 Old 473 ml — — FDA listed —
Harris Teeter 999 mg/mL 69256-0831-43 Harris 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 72476-0877-43 Retail 473 ml — — FDA listed —
Mineral Oil 999 mg/mL 83324-0171-16 Chain 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.

Availability & generic status

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio163 products on file

More NDCs from CARDINAL HEALTH 110, LLC. DBA LEADER labeler code 70000

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 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 🤒 Adverse Reactions 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Use for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.

⏱️ Dosage and Administration 86 words ▾

Directions do not take with meals take only at bedtime may be taken as a single daily dose or in divided doses adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours children under 6 years of age - do not use, consult a doctor

⚠️ Warnings 4 words ▾

Warnings for this product

🤒 Adverse Reactions 10 words ▾

Adverse reaction DIST. BY CAH DUBLIN, OH 43017 www.myleader.com 1-800-200-6313

📦 Storage and Handling 8 words ▾

Other Information keep tightly closed. Protect from sunlight.

🧪 Active Ingredient 5 words ▾

Active ingredient Mineral oil 99.9%

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients mixed tocopherols (added as a stabilizer)

🎯 Purpose 3 words ▾

Purpose Lubricant laxative

📄 Do Not Use 32 words ▾

Do not use if you have difficulty swallowing in children under 6 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 28 words ▾

Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks

📄 Ask a Doctor or Pharmacist Before Use If 39 words ▾

Ask a doctor or pharmacist before use if you are presently taking a stool softener laxative taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

📄 When Using This Product 13 words ▾

When using this product do not take with meals. Take only at bedtime.

📄 Stop Use and Ask a Doctor If 28 words ▾

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 8 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 2 words ▾

Questions? 1-888-593-0593

📄 Package Label / Principal Display Panel 42 words ▾

Principal Display Panel SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION LEADER™ NDC 70000-0663-1 Mineral Oil Lubricant Laxative For relief of occasional constipation 100% Money back Guarantee Odorless Tasteless, Colorless 16 FL OZ (1 PT) 473 mL image description image description

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 – Q1 2026 · 5 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
93
Units reimbursed last 4 qtrs
20.4K
Gross reimbursed last 4 qtrs
$1.4K
Avg / prescription
$14.70
Avg / unit
$0.0671
Latest quarter Q1 2026
24Rx
Medicaid pays / mL
$0.0671
gross reimbursed
vs
NADAC / mL
$0.0099
acquisition cost
=
Spread
+$0.0572
+578% 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 ⓘ
24% FFS 76% MCO
Fee-for-service · 22 Rx Managed care · 71 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 3,625 units · 28.0 per 100k residents PA New Jersey: 12,469 units · 134 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 4,277 units · 94.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
28.0134
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
🏆 Top states by units · per 100k residents
1 New Jersey 134 /100k
2 Kentucky 94.5 /100k
3 Pennsylvania 28.0 /100k
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.
← 70000-0662-01 · Cardinal 70000-0665-01 · 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.