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Colace Docusate sodium 50 mg Capsule, Liquid Filled, 42-count — NDC 67618-0111-42 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Colace Docusate sodium 50 mg Capsule, Liquid Filled, 42-count — NDC 67618-111-42 (Billing 67618-0111-42)

by Atlantis Consumer Healthcare, Inc. · 1 BOTTLE in 1 CARTON / 42 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 42 capsules of Colace Docusate sodium 50 mg Capsule, Liquid Filled from Atlantis Consumer Healthcare, Inc., marketed since Jan 1900 and currently FDA-listed.

NDC 67618-0111-42
🏷️ FDA NDC (as labeled) 67618-111-42 billing pads the product segment with a zero
This package
Contains42-count Pack sizes4 compare ↓
Product page 67618-0111-28 Also comes in: 28 capsules 67618-111-28 60 capsules 67618-111-60 100 capsules 67618-111-10
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 10, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67618-111-42
Product NDC 67618-111
11-digit billing NDC 67618011142
RxCUI 1247759, 1247761
UNII F05Q2T2JA0
UPC 0367618000076, 0367618111284, 0367618000007
Application # M007
SPL Set ID a1591da0-a1a9-9583-3cf5-788b8fee3814
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1900-01-07
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DOCUSATE SODIUM

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

GCN Seq No 003013
GCN 09105
HICL code 001326
Ingredient (HICL) Docusate Sodium
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 COLACE CLEAR 50 MG SOFTGEL
FDB brand name Colace Clear
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 003013
  • GCN: 09105
  • HICL (First Databank): 001326
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 1247759
Why two NDCs? The FDA registers this code as 67618-111-42 — 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 → 67618-0111-42. 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 Softeners, emollients class.

Drug family (ATC) Softeners, emollients
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

Label name COLACE CLEAR 50 MG SOFTGEL Ingredient Docusate Sodium
📖 About the active ingredient: Docusate Sodium MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Read the full MedlinePlus article ↗
🧪 What is this product?

Colace is an over-the-counter oral capsule containing docusate sodium, a stool softener. This product is an OTC monograph drug, meaning it is marketed under FDA's established rules for this category of medicine. Docusate sodium is typically used to soften stool and ease bowel movements, commonly taken by people who want to avoid straining during defecation.

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.
Try another pack size: 28 capsules 60 capsules 100 capsules
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 Per unit Per pack Marketing startMarketing endStatus
67618-0111-28 67618-111-28 Main listing 1 BOTTLE in 1 CARTON / 28 CAPSULE, LIQUID FILLED in 1 BOTTLE $0.2563 / ea $7.18 1900-01-07 — Active
67618-0111-10 67618-111-10 1 BOTTLE in 1 CARTON / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE — — 2025-12-01 — Active
67618-0111-42 You're viewing this 1 BOTTLE in 1 CARTON / 42 CAPSULE, LIQUID FILLED in 1 BOTTLE — — 2024-02-01 — Active
67618-0111-60 67618-111-60 1 BOTTLE in 1 CARTON / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE — — 2024-04-01 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 42-count package — 1 bottle in 1 carton / 42 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 67618-0111-28?
Both are Colace Docusate sodium 50 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 42-count one, while NDC 67618-0111-28 is the 28 capsules package.
What NDC number is used to bill for this package of Colace Docusate sodium 50 mg Capsule, Liquid Filled?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Docusate Sodium 50Mg Softgel (Red) 50 mg 51316-0651-01 CVS 100 capsules — — FDA listed —
Docusate Sodium softgels 50mg (Dye Free) 50 mg 51316-0652-03 CVS 30 capsules — — FDA listed —
Docusate Sodium 50 Mg 53345-0015-01 Humanwell 20000 capsules — — FDA listed —
Colace 50 mgthis 67618-0111-42 Atlantis 42 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

🏛️
1900
On the market since
Jan 1900
📍
2026
Currently FDA-listed
126 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.

What it looks like

Color Brown
ShapeOval
ImprintCLR;50
Size11 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.

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

The official label also statesInactive ingredients gelatin, glycerin, PEG 400, propylene glycol, sorbitol Soft gels are imprinted with edible dye-free ink. Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 Questions? 1-833-288-2684 ©2023 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

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 marketedJan 1900
Product typeHuman Otc Drug
Portfolio17 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.

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 Forms and Strengths 📦 How Supplied / Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

💊 Dosage Forms and Strengths 50 words ▾

Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-6 soft gels daily children 2 to under 12 years of age take 1-3 soft gels daily children under 2 years ask a doctor

📦 How Supplied / Storage and Handling 24 words ▾

Other information each soft gel contains: sodium 3 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed.

🧪 Active Ingredient 2 words ▾

Drug Facts

🧪 Inactive Ingredients 43 words ▾

Inactive ingredients gelatin, glycerin, PEG 400, propylene glycol, sorbitol Soft gels are imprinted with edible dye-free ink. Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 Questions? 1-833-288-2684 ©2023 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

🎯 Purpose 13 words ▾

Active ingredient Purpose (in each soft gel) Docusate sodium 50 mg........... Stool softener

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
28 capsules67618-0111-28 5,451 Rx · $87,205
100 capsules67618-0111-10 No Medicaid data
42 capsules this page67618-0111-42 No Medicaid data
60 capsules67618-0111-60 No Medicaid data
Drug total (last 4 qtrs): 5,451 Rx · 247,199 units · $87,205 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 28 capsules (67618-0111-28), 60 capsules (67618-0111-60), 100 capsules (67618-0111-10). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 67618-0110-10 · Atlantis 67618-0120-06 · 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.