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Humco Mineral Oil Heavy 1000 mg/mL Liquid, 3800 mL — NDC 00395-1685-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Humco Mineral Oil Heavy 1000 mg/mL Liquid, 3800 mL — NDC 0395-1685-28 (Billing 00395-1685-28)

by Humco Holding Group, Inc. · 3800 mL in 1 BOTTLE, PLASTIC

This is a package of 3,800 mL of Humco Mineral Oil Heavy 1000 mg/mL Liquid from Humco Holding Group, Inc., marketed since Mar 1998 and currently FDA-listed. It is this product's only package size.

NDC 00395-1685-28
🏷️ FDA NDC (as labeled) 0395-1685-28 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0395-1685-28 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0395 labeler · 1685 product · 28 package
Package marketed since
Nov 14, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
3,800 mL per package
Barcode (UPC)
0303951685280
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0395-1685-28
Product NDC 0395-1685
11-digit billing NDC 00395168528
NCPDP billing unit ML — per mL (volume)
RxCUI 311714
UNII T5L8T28FGP
UPC 0303951685280
Application # M007
SPL Set ID 9f943fdf-5058-4e18-ba96-6be112bf72ca
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-03-25
Route ORAL
Dosage form LIQUID
Substance MINERAL OIL

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

GPI-14 46400010001750
GPI class Mineral Oil Heavy
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 HEAVY
FDB brand name Mineral Oil Heavy
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002997
  • GCN: 09020
  • GPI-14 (Medi-Span): 46400010001750
  • HICL (First Databank): 001319
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 311714
Why two NDCs? The FDA registers this code as 0395-1685-28 — a 4-4-2 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 labeler segment → 00395-1685-28. 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 HEAVY 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00395-1685-28 You're viewing this Main listing 3800 mL in 1 BOTTLE, PLASTIC 2017-11-14 — Active

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/mLthis 00395-1685-28 Humco 3800 ml — — FDA listed —
Mineral Oil Heavy 1000 mg/mL 82645-0906-16 Pharma 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 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

🏛️
1998
On the market since
Mar 1998
📍
2026
Currently FDA-listed
28 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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesdl-alpha-tocopherol as a preservative.

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

LabelerHumco Holding Group, Inc.
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio35 products on file

More NDCs from Humco Holding Group, Inc. labeler code 00395

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 4 words ▾

Principal display panel capture(2)

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Humco Mineral Oil Heavy (this brand).

Top reported reactions

Pyrexia142
Fatigue137
Headache127
Pain125
Rash121
Nausea117
Pulmonary Embolism112

Age at onset

Neonate1
Child2
Adolescent4
Adult100
Elderly145

Reporter sex

1,146 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization557
Death160
Life-threatening65
Disabling28
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 174 54
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 ✓ Available
Inactive ingredients (structured) ✓ 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 Humco Holding Group, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Humco Holding Group, Inc. 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.
← 00395-1673-28 · Humco 00395-2325-16 · Humco →
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.