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Docusate Sodium and Sennosides 8.6 mg; 50 mg Capsule, Gelatin Coated, 500-count — NDC 35916-0454-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Docusate Sodium and Sennosides 8.6 mg; 50 mg Capsule, Gelatin Coated, 500-count — NDC 35916-0454-1 (Billing 35916-0454-01)

by SOFTGEL HEALTHCARE PRIVATE LIMITED · 500 CAPSULE, GELATIN COATED in 1 BOTTLE

This is a package of 500 capsules of Docusate Sodium and Sennosides 8.6 mg; 50 mg Capsule, Gelatin Coated from SOFTGEL HEALTHCARE PRIVATE LIMITED, marketed since Jun 2024 and currently FDA-listed. It is this product's only package size.

NDC 35916-0454-01
🏷️ FDA NDC (as labeled) 35916-0454-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 35916-0454-1
Product NDC 35916-0454
11-digit billing NDC 35916045401
RxCUI 1791612
UNII 3FYP5M0IJX, F05Q2T2JA0
UPC 0335916045419
Application # M007
SPL Set ID 1ad73079-ebb3-dae7-e063-6294a90a0558
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-22
Route ORAL
Dosage form CAPSULE, GELATIN COATED
Substance SENNOSIDES; DOCUSATE SODIUM
Quick answers
  • RxCUI (RxNorm): 1791612
Why two NDCs? The FDA registers this code as 35916-0454-1 — a 5-4-1 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 package segment → 35916-0454-01. 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.

Clinical

📖 About the active ingredient: Sennosides; Docusate Sodium 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?

This is an over-the-counter oral capsule containing two active ingredients commonly used together to address occasional constipation. Sennosides function as a natural stimulant laxative derived from senna plant material, while docusate sodium is a stool softener that helps ease bowel movements by increasing water retention in the stool. The combination of these two ingredients is formulated to work on different mechanisms within the digestive tract.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
35916-0454-01 You're viewing this Main listing 500 CAPSULE, GELATIN COATED in 1 BOTTLE 2024-06-22 — Active

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 mgthis 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 mg 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerSOFTGEL HEALTHCARE PRIVATE LIMITED
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code35916
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio23 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 and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

Uses relieves occasional constipation (irregularity) generally causes bowel movement in 6-12 hours

⏱️ Dosage and Administration 64 words ▾

Directions take preferably at bedtime or as directed by a doctor. Age Starting Dosage Maximum Dosage adults and children 12 years of age and older 2 softgels once a day 4 softgels twice a day children 6 to 12 years of age 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor

⚠️ Warnings 28 words ▾

Warnings Do not use if you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week, unless directed by a doctor

🧪 Active Ingredient 12 words ▾

Active ingredient (in each softgel) Docusate Sodium 50 mg Sennosides 8.6 mg

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Propylene glycol, Povidone, Colloidal Silicon Dioxide, Yellow wax, Polyethylene glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Red No.40, Titanium dioxide and Purified water.

🎯 Purpose 4 words ▾

Purpose Stool softener Laxative

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 Docusate Sodium and Sennosides — the ingredient across all brands.

Top reported reactions

Fatigue510
Nausea504
Constipation411
Diarrhoea359
Dyspnoea358
Pain320
Fall308

Age at onset

Child4
Adolescent6
Adult211
Elderly295

Reporter sex

5,607 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization1,831
Life-threatening100
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 248 106
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 SOFTGEL HEALTHCARE PRIVATE LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SOFTGEL HEALTHCARE PRIVATE LIMITED 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.
← 35916-0453-01 · SOFTGEL 35916-0461-01 · Softgel →
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.