Home › NDC Lookup › Ingredients › Mineral Oil › 49580-0334-06
💊image loading
(from DailyMed)

Mineral oil 100 mg/100mL Oil, 473 mL

by P & L Development, LLC · 473 mL in 1 BOTTLE (49580-0334-6)
NDC 49580-0334-06
🏷️ FDA NDC (as labeled) 49580-0334-6 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) 49580-0334-6
Product NDC 49580-0334
11-digit billing NDC 49580033406
NCPDP billing unit ML — per mL (volume)
UNII T5L8T28FGP
UPC 0349580334168
Application # M007
SPL Set ID 68e88119-1468-4ab7-a5fa-242d960d25df
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-08-31
Route ORAL
Dosage form OIL
Substance 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
Why two NDCs? The FDA registers this code as 49580-0334-6 — 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 → 49580-0334-06. 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.

🏭 Manufacturer & labeler

LabelerP & L Development, LLC
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code49580
First marketedAug 2014
Product typeHuman Otc Drug
Portfolio124 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 MINERAL OIL 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.

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.

💲 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 eachPer 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.
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
Mineral Oil 100 mg/100mL 46122-0395-16 AmerisourceBergen 473 ml $0.010 — Availability likely —
LEADER Mineral Oil 1000 mg/mL 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/100mLthis 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 —
Mineral oil 100 mg/100mL 63941-0334-16 Best 473 ml — — FDA listed —
Mineral oil 100 mg/100mL 49035-0035-16 EQUATE 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

🏛️
2014
On the market since
Aug 2014
📍
2026
Currently FDA-listed
12 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49580-0334-06 You're viewing this 473 mL in 1 BOTTLE (49580-0334-6) 2014-08-31 Active

🧭 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 FDA registers it as 49580-0334-6, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49580-0334-06, written without dashes as 49580033406. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49580-0334-06, the first segment (49580) is the labeler code FDA assigned to P & L Development, LLC; the middle segment (0334) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
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 P & L Development, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
P & L Development, 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.

📄 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
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 83 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: oral dosage is a minimum single dose of 15 mL to a maximum daily dose of 45 mL children 6 years to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL children under 12 years, consult a doctor

⚠️ Warnings 138 words ▾

Warnings Do not use in children under 12 years of age, pregnant women, bedridden patients or aged, or if you have difficulty swallowing if you are presently taking a stool softener laxative for longer than 1 week 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 When using this product do not take with meals take only at bedtime 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, ask a health professional before use. Keep out of reach of children.

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

🧪 Active Ingredient 5 words ▾

Active ingredient Mineral oil 100%

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients Vitamin E as stabilizer

🎯 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 ↗
← 49580-0314-02 · P 49580-0343-02 · P →
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.