Colace Docusate sodium 50 mg Capsule, Liquid Filled, 100-count
by Atlantis Consumer Healthcare, Inc. · 1 BOTTLE in 1 CARTON (67618-111-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE
NDC 67618-0111-10
🏷️ FDA NDC (as labeled)
67618-111-10
billing pads the product segment with a zero
This package
Contains100-count
Pack sizes4 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Sep 10, 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)
67618-111-10
Product NDC
67618-111
11-digit billing NDC
67618011110
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
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
Why two NDCs?
The FDA registers this code as 67618-111-10 — 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 → 67618-0111-10. 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.
🏭 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.
🩺 Clinical
Label name COLACE CLEAR 50 MG SOFTGEL Ingredient Docusate Sodium
🧪 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.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Docusate Sodium — tap one for details:
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 Docusate sodium?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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.
💲 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 | 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 67618-0111-10 | Atlantis | 100 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.
💊 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.
Drug total (last 4 qtrs): 5,402 Rx · 244,225 units · $86,490 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
🔬 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 (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 42%
Female · 58%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 67618-0111-28 | 1 BOTTLE in 1 CARTON (67618-111-28) / 28 CAPSULE, LIQUID FILLED in 1 BOTTLE | $0.2563 / ea | $7.18 | 1900-01-07 | Active |
| 67618-0111-10 You're viewing this | 1 BOTTLE in 1 CARTON (67618-111-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE | — | — | 2025-12-01 | Active |
| 67618-0111-42 | 1 BOTTLE in 1 CARTON (67618-111-42) / 42 CAPSULE, LIQUID FILLED in 1 BOTTLE | — | — | 2024-02-01 | Active |
| 67618-0111-60 | 1 BOTTLE in 1 CARTON (67618-111-60) / 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 NDC 67618-0111-10?
NDC 67618-0111-10 is a 100-count package — 1 bottle in 1 carton / 100 capsule, liquid filled in 1 bottle.
What is the difference between NDC 67618-0111-10 and NDC 67618-0111-28?
Both are Colace Docusate sodium 50 mg Capsule, Liquid Filled — the drug itself is identical. NDC 67618-0111-10 is the 100-count package, 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?
Bill NDC 67618-0111-10 — the 11-digit billing format is 67618011110. 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.
🧭 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 FDA registers it as 67618-111-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 67618-0111-10, written without dashes as 67618011110. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 67618-0111-10, the first segment (67618) is the labeler code FDA assigned to Atlantis Consumer Healthcare, Inc.; the middle segment (0111) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
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), 42 capsules (67618-0111-42), 60 capsules (67618-0111-60). 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.
📄 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 ▾
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
💊 Dosage Forms and Strengths ▾
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 ▾
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 ▾
Drug Facts
🧪 Inactive Ingredients ▾
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 ▾
Active ingredient Purpose (in each soft gel) Docusate sodium 50 mg........... Stool softener
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.