Mineral Oil 100 mg/100mL Oil, 473 mL
by AmerisourceBergen (Good Neighbor Pharmacy) 46122 · 473 mL in 1 BOTTLE, PLASTIC (46122-395-16)
NDC 46122-0395-16
🏷️ FDA NDC (as labeled)
46122-395-16
billing pads the product 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 →
🆔 Identity & classification
FDA NDC (as labeled)
46122-395-16
Product NDC
46122-395
11-digit billing NDC
46122039516
NCPDP billing unit
ML — per mL (volume)
UNII
T5L8T28FGP
UPC
0346122395168
Application #
M007
SPL Set ID
581f81a0-7488-4c90-b33e-06c6301a4fd2
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2016-11-30
Route
ORAL, TOPICAL
Dosage form
OIL
Substance
MINERAL OIL
GPI-14
46400010001700
GPI class
GNP 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 46122-395-16 — 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 → 46122-0395-16. 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
LabelerAmerisourceBergen (Good Neighbor Pharmacy) 46122
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code46122
First marketedNov 2016
Product typeHuman Otc Drug
Portfolio26 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?
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.
💬 Questions about Mineral Oil?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII R0ZB2556P8
Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
1 inactive ingredient listed in the exact product block matched to this NDC.
The official label also statesVitamin E as stabilizer
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.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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.010 | $4.54 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0205 | $9.70 / 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 71% over the last 17 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mineral Oil 100 mg/100mLthis 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 | +9% |
| 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 | — |
| Mineral Oil 100 mg/100mL 36800-0334-16 | TOP | 473 ml | — | — | FDA listed | — |
| Mineral Oil 100 mg/100mL 56062-0334-16 | Publix | 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
🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 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.
🗺️ 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 46122-0395-16, 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
118
Units reimbursed last 4 qtrs
31K
Gross reimbursed last 4 qtrs
$634.67
Avg / prescription
$5.38
Avg / unit
$0.0205
Latest quarter Q4 2025
33Rx
Medicaid pays / mL
$0.0205
gross reimbursed
vs
NADAC / mL
$0.0096
acquisition cost
=
Spread
+$0.0109
+114% 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 · 26 Rx Managed care · 92 Rx
State Medicaid map
Units reimbursed · per 100k residents
55.076.7
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46122-0395-16 You're viewing this | 473 mL in 1 BOTTLE, PLASTIC (46122-395-16) | 2016-11-30 | 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours
⏱️ Dosage and Administration ▾
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 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 6 years of age: consult a doctor
⚠️ Warnings ▾
Warnings Do not use in children under 12 years of age, pregnant wormen, 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 ▾
Active Ingredient Mineral Oil, USP 100%
🧪 Inactive Ingredients ▾
Inactive Ingredient Vitamin E as stabilizer
🎯 Purpose ▾
Purpose Lubricant laxative
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 ↗
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.