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Colace Fast-Acting Saline Laxative Magnesium hydroxide 800 mg Capsule, 60-count — NDC 67618-0102-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Colace Fast-Acting Saline Laxative Magnesium hydroxide 800 mg Capsule, 60-count — NDC 67618-102-60 (Billing 67618-0102-60)

by Atlantis Consumer Healthcare, Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 60 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 60 capsules of Colace Fast-Acting Saline Laxative Magnesium hydroxide 800 mg Capsule from Atlantis Consumer Healthcare, Inc., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 67618-0102-60
🏷️ FDA NDC (as labeled) 67618-102-60 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 67618-102-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67618 labeler · 102 product · 60 package
Package marketed since
Mar 16, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6761810260 2
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67618-102-60
Product NDC 67618-102
11-digit billing NDC 67618010260
RxCUI 2738919
UNII NBZ3QY004S
Application # M007
SPL Set ID 572adfaf-6e26-42e5-b65d-6d356a0bdfa9
Established class (EPC) Calculi Dissolution Agent; Osmotic Activity
Mechanism of action Magnesium Ion Exchange Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption; Inhibition Small Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-16
Route ORAL
Dosage form CAPSULE
Substance MAGNESIUM HYDROXIDE
Quick answers
  • RxCUI (RxNorm): 2738919
Why two NDCs? The FDA registers this code as 67618-102-60 — 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 → 67618-0102-60. 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.

RxNorm drug class

This medicine belongs to the Magnesium compounds class.

Drug family (ATC) Magnesium compounds, Other urologicals
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product you pick up. Most magnesium hydroxide products — like Dulcolax liquid, Colace Fast-Acting Saline Laxative, MiraFAST soft chews, and many Milk of Magnesia...
  • What is magnesium hydroxide actually used for?
  • Yes, a few things matter here. If you're taking a liquid or suspension, shake it well before every use. Whatever form you take, follow it with a full 8-ounce glass of water or anot...
  • How should I take it — does it matter when or how I drink it?
📖 Read our full Magnesium Hydroxide guide →
3
Nutrient depletion considerations

Magnesium Hydroxide (OTC drug) may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Magnesium Hydroxide (OTC drug) 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67618-0102-60 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 60 CAPSULE in 1 BOTTLE, PLASTIC 2026-03-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Colace Fast-Acting Saline Laxative 800 mgthis 67618-0102-60 Atlantis 60 capsules — — 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

What it looks like

Color White
ShapeOval
ImprintCL800
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 Magnesium Hydroxide 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescroscarmellose sodium, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.

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

LabelerAtlantis Consumer Healthcare, Inc.
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code67618
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from Atlantis Consumer Healthcare, Inc. labeler code 67618

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor or Pharmacist Before Use If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses for relief of occasional constipation (irregularity) this product generally produces bowel movement in 30 minutes to 6 hours

⏱️ Dosage and Administration 79 words ▾

Directions drink a full glass (8 oz) of liquid with each dose dose may be taken as a single daily dose, in divided doses, or as directed by a doctor do not exceed the maximum recommended daily dose in a 24 hour period Adults and children 12 years of age and over: Take 3 to 6 capsules Children 6 to under 12 years of age: Take 2 to 3 capsules Children under 6 years of age: Ask a doctor

⚠️ Warnings 31 words ▾

Warnings Ask a doctor before use if you have kidney disease a magnesium-restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts over 2 weeks

📦 Storage and Handling 18 words ▾

Other information each capsule contains magnesium 335mg and sodium 1mg store at 20°C to 25°C (68°F to 77°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each capsule) Magnesium hydroxide 800 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients croscarmellose sodium, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.

🎯 Purpose 3 words ▾

Purpose Saline laxative

📄 Do Not Use 40 words ▾

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than1 week

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 2 words ▾

Questions? 1-833-288-2684

📄 Package Label / Principal Display Panel 79 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Constipation Relief In As Little As 30 Minutes Colace® Magnesium Hydroxide, 800mg Saline Laxative NEW! FAST-ACTING LAXATIVE √ Gentle, Effective Constipation Relief √ Works Naturally With Your Body √ Cramp & Stimulant-Free 60 Capsules Retain this carton for important information. For added savings, visit: colacecapsules.com Dist. by: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA Questions? 1-833-288-2684 ©2025 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

A1125 R54369 Carton

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 Colace Fast-Acting Saline Laxative (this brand).

Top reported reactions

Constipation845
Pain745
Fall713
Cognitive Disorder646
Hypotension640
Orthostatic Hypotension616
Balance Disorder610

Age at onset

Neonate6
Infant1
Child5
Adolescent6
Adult267
Elderly520

Reporter sex

3,586 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization2,370
Death616
Life-threatening430
Disabling228
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 321 0
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 Atlantis Consumer Healthcare, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Atlantis Consumer Healthcare, 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.
← 67618-0101-01 · Atlantis 67618-0110-10 · Atlantis →
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.