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CVS Health Stool Softener Plus stimulant laxative Softgel Docusate sodium, Sennosides 50 mg; 8.6 mg Capsule, Liquid Filled, 60-count — NDC 51316-0318-06 package photo

CVS Health Stool Softener Plus stimulant laxative Softgel Docusate sodium, Sennosides 50 mg; 8.6 mg Capsule, Liquid Filled, 60-count

by CVS Pharmacy, Inc · 1 BOTTLE in 1 CARTON (51316-318-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE
NDC 51316-0318-06
🏷️ FDA NDC (as labeled) 51316-318-06 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 51316-318-06
Product NDC 51316-318
11-digit billing NDC 51316031806
RxCUI 1791612
UNII F05Q2T2JA0, 3FYP5M0IJX
Application # M007
SPL Set ID 2881d83d-9929-677a-e063-6394a90a0424
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-19
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DOCUSATE SODIUM; SENNOSIDES
Why two NDCs? The FDA registers this code as 51316-318-06 — 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 → 51316-0318-06. 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 Contact laxatives class.

Drug family (ATC) Contact laxatives
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

LabelerCVS Pharmacy, Inc
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio104 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

📖 About the active ingredient: Docusate Sodium; Sennosides MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

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

CVS Health Stool Softener Plus is an over-the-counter oral capsule containing docusate sodium and sennosides. Docusate sodium is a stool softener typically used to make bowel movements easier by increasing moisture in the stool. Sennosides are a stimulant laxative commonly used to promote bowel movement activity. This combination product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and use guidelines for this drug category.

1
Nutrient depletion considerations

Docusate Sodium, Sennosides (OTC drug) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Docusate Sodium, Sennosides (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.

💊 What it looks like

Color red
ShapeOval
Imprint831
Size13 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • 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.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesbeeswax, colloidal silicon dioxide, D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxymethyl cellulose, sorbitol sorbitan solution, soy lecithin, titanium dioxide

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Senna S 50 mg/1; 8.6 mg 00363-1173-60 Walgreens 60 capsules — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 00363-6683-60 Walgreens 60 capsules — — FDA listed —
Docusate Sodium and Sennosides 8.6 mg/1; 50 mg 35916-0453-01 SOFTGEL 500 capsules — — FDA listed —
Docusate Sodium and Sennosides 8.6 mg/1; 50 mg 35916-0454-01 SOFTGEL 500 capsules — — FDA listed —
Docusate Sodium and Sennosides 50 mg/1; 8.6 mg 35916-0477-01 SOFTGEL 1500 capsules — — FDA listed —
CVS Health Stool Softener Plus stimulant laxative Softgel 50 mg/1; 8.6 mgthis 51316-0318-06 CVS 60 capsules — — FDA listed —
Gencare-Senna-S Softgel 50 mg/1; 8.6 mg 72090-0054-01 Pioneer 100 capsules — — FDA listed —
Senna S 50 mg/1; 8.6 mg 83059-0120-06 Shield 60 capsules — — FDA listed —
Senna-S Softgel 50 mg/1; 8.6 mg 84324-0030-01 NUVICARE 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.

🔬 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 Docusate sodium, Sennosides — the ingredient across all brands.

Top reported reactions

Fatigue3,393
Nausea3,114
Diarrhoea2,398
Constipation2,342
Dyspnoea2,323
Death2,142
Pain2,124

Reporter sex

38,112 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Death4,942
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,651 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51316-0318-06 You're viewing this 1 BOTTLE in 1 CARTON (51316-318-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE 2025-03-19 Active

🧭 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 51316-318-06, 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: 51316-0318-06, written without dashes as 51316031806. 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 51316-0318-06, the first segment (51316) is the labeler code FDA assigned to CVS Pharmacy, Inc; the middle segment (0318) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 CVS Pharmacy, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Pharmacy, 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 and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 16 words ▾

Uses • relieves occasional constipation (irregularity) • generally produces bowel movement in 6 to 12 hours

⏱️ Dosage and Administration 55 words ▾

Directions • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 softgels daily children 6 to under 12 years of age take 1-2 softgels daily children under 6 years of age ask a doctor

⚠️ Warnings 126 words ▾

Warnings Do not use • laxative products for longer than 1 week unless told to do so by a doctor • if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 right away.

📦 Storage and Handling 17 words ▾

Other information • each softgel contains: sodium 4 mg • store at room temperature between 20°-25°C (68°-77°F)

🧪 Active Ingredient 12 words ▾

Active ingredients (in each softgel) Docusate sodium 50 mg Sennosides 8.6 mg

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients beeswax, colloidal silicon dioxide, D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxymethyl cellulose, sorbitol sorbitan solution, soy lecithin, titanium dioxide

🎯 Purpose 5 words ▾

Purpose Stool softener Stimulant laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51316-0317-62 · CVS 51316-0319-60 · CVS →
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.