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Mineral Oil 100 mg/100mL Oil, 473 mL — NDC 46122-0395-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mineral Oil 100 mg/100mL Oil, 473 mL — NDC 46122-395-16 (Billing 46122-0395-16)

by AmerisourceBergen (Good Neighbor Pharmacy) 46122 · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Mineral Oil 100 mg/100mL Oil from AmerisourceBergen (Good Neighbor Pharmacy) 46122, marketed since Nov 2016 and currently FDA-listed; retail pharmacies pay about $0.0099 per mL (NADAC). It is this product's only package size.

NDC 46122-0395-16
🏷️ FDA NDC (as labeled) 46122-395-16 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 46122-395-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
46122 labeler · 395 product · 16 package
Package marketed since
Nov 30, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
473 mL per package
Barcode (UPC)
0346122395168
Medicaid fills, this package
87 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

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

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
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
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.

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 $0.0213 $10.07 / 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 2021 Dec 2023 Mar 2026 Sep 2026 $0.011 $0.005
▲ Up 77% over the last 18 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
46122-0395-16 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2016-11-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 +6%
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.

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 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.

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

More NDCs from AmerisourceBergen (Good Neighbor Pharmacy) 46122 labeler code 46122

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 📄 Do Not Use 📄 Ask a Doctor 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 84 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 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 139 words ▾

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 6 words ▾

Active Ingredient Mineral Oil, USP 100%

🧪 Inactive Ingredients 6 words ▾

Inactive Ingredient Vitamin E as stabilizer

🎯 Purpose 3 words ▾

Purpose Lubricant laxative

📄 Do Not Use 36 words ▾

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 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

📄 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 11 words ▾

If pregnant or breast feeding, ask a health professional before use

📄 Keep Out of Reach of Children 22 words ▾

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.

📄 Package Label / Principal Display Panel 59 words ▾

Principal Display Panel SAFETY SEALED Mineral Oil Lubricant Laxative Odorless-Tasteless Crystal Clear FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by AmerisourceBergen 1 West First Avenue, Conshohocken, PA 19428 www.mygnp.com Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Package Label GOOD NEIGHBOR PHARMACY Mineral Oil Mineral oil 100%

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
87
Units reimbursed last 4 qtrs
27K
Gross reimbursed last 4 qtrs
$572.97
Avg / prescription
$6.59
Avg / unit
$0.0213
Latest quarter Q1 2026
0Rx
Medicaid pays / mL
$0.0213
gross reimbursed
vs
NADAC / mL
$0.0099
acquisition cost
=
Spread
+$0.0114
+115% 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 ⓘ
30% FFS 70% MCO
Fee-for-service · 26 Rx Managed care · 61 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: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 21,428 units · 55.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,208 units · 48.8 per 100k residents KY West Virginia: no data reported WV Virginia: 3,323 units · 38.1 per 100k residents 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
38.155.0
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 California 55.0 /100k
2 Kentucky 48.8 /100k
3 Virginia 38.1 /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.
← 46122-0392-58 · Amerisource 46122-0410-62 · AmeriSource →
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.