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Mineral Oil Heavy 1000 mg/mL Liquid, 950 mL — NDC 82645-906-32 (Billing 82645-0906-32)

by Pharma Nobis, LLC · 950 mL in 1 BOTTLE, PLASTIC

This is a package of 950 mL of Mineral Oil Heavy 1000 mg/mL Liquid from Pharma Nobis, LLC, marketed since Dec 2018 and currently FDA-listed.

NDC 82645-0906-32
🏷️ FDA NDC (as labeled) 82645-906-32 billing pads the product segment with a zero
This package
Contains950 mL Pack sizes2 compare ↓
Product page 82645-0906-16 Also comes in: 473 ml 82645-906-16
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 82645-906-32 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82645 labeler · 906 product · 32 package
Package marketed since
Jan 31, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8264590632 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82645-906-32
Product NDC 82645-906
11-digit billing NDC 82645090632
RxCUI 311714
UNII T5L8T28FGP
Application # M007
SPL Set ID e42f6c6d-c4de-02c6-e053-2995a90a3ace
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-18
Route ORAL
Dosage form LIQUID
Substance MINERAL OIL
Quick answers
  • RxCUI (RxNorm): 311714
Why two NDCs? The FDA registers this code as 82645-906-32 — a 5-3-2 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 product segment → 82645-0906-32. 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.

Clinical

📗 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 473 ml
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
82645-0906-16 82645-906-16 Main listing 473 mL in 1 BOTTLE, PLASTIC 2018-12-18 — Active
82645-0906-32 You're viewing this 950 mL in 1 BOTTLE, PLASTIC 2020-01-31 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 950 mL — 950 ml in 1 bottle, plastic.
How does this package differ from NDC 82645-0906-16?
Both are Mineral Oil Heavy 1000 mg/mL Liquid — the drug itself is identical. This page's package is the 950 mL one, while NDC 82645-0906-16 is the 473 ml package.
What NDC number is used to bill for this package of Mineral Oil Heavy 1000 mg/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LEADER Mineral Oil 1000 mg/mL 70000-0448-01 Cardinal 473 ml $0.010 — FDA listed —
Humco Mineral Oil Heavy 1000 mg/mL 00395-1685-28 Humco 3800 ml — — FDA listed —
Mineral Oil Heavy 1000 mg/mLthis 82645-0906-32 Pharma 950 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 —
Mineral Oil 1000 mg/mL 48433-0202-30 Safecor 30 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

🏛️
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.

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.

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

LabelerPharma Nobis, LLC
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code82645
First marketedDec 2018
Product typeHuman Otc Drug
Portfolio40 products on file

More NDCs from Pharma Nobis, LLC labeler code 82645

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 🧪 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 17 words ▾

Use For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

⏱️ Dosage and Administration 38 words ▾

Directions Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime. Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime. Children under 6 yrs. of age: Consult a doctor before use.

⚠️ Warnings 72 words ▾

Warnings Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives. Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

🧪 Active Ingredient 5 words ▾

Active ingredient Mineral Oil Heavy

🧪 Inactive Ingredients 6 words ▾

Inactive ingredient dl-alpha-tocopherol as a preservative.

🎯 Purpose 2 words ▾

Purpose Laxative

📄 Ask a Doctor Before Use If 25 words ▾

Ask a doctor before use if you are currently taking a stool softener laxative. If pregnant or brest feeding ask a health professional before use.

📄 Stop Use and Ask a Doctor If 22 words ▾

When using this Product discotinue use and consult a doctor if there is a failure to have a bowel movement after use.

📄 Keep Out of Reach of Children 32 words ▾

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 10 words ▾

Other information Keep tightly closed and protect from direct light.

📄 Package Label / Principal Display Panel 17 words ▾

CVS Label CVS Mineral Oil 32 oz Back.jpg CVS Mineral Oil 32 oz Front.jpg

Leader Label LDRMinH.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pharma Nobis, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 473 ml (82645-0906-16). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Pharma Nobis, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 82645-0904-01 · Pharma 82645-0907-16 · Pharma →
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.