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Laxative Docusate Sodium with Senna Docusate Sodium and Sennosides 50 mg; 8.6 mg Tablet, Coated, 100-count — NDC 36800-861-01 (Billing 36800-0861-01)

by TOPCO ASSOCIATES LLC · 1 BOTTLE in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE

This is a package of 100 tablets of Laxative Docusate Sodium with Senna Docusate Sodium and Sennosides 50 mg; 8.6 mg Tablet, Coated from TOPCO ASSOCIATES LLC, marketed since May 2021 and currently FDA-listed. It is this product's only package size.

NDC 36800-0861-01
🏷️ FDA NDC (as labeled) 36800-861-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-861-01
Product NDC 36800-861
11-digit billing NDC 36800086101
RxCUI 998740
UNII F05Q2T2JA0, 3FYP5M0IJX
Application # M007
SPL Set ID cf9075d8-e20e-419a-b996-9b12f49f05f2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-05-01
Route ORAL
Dosage form TABLET, COATED
Substance DOCUSATE SODIUM; SENNOSIDES
Quick answers
  • RxCUI (RxNorm): 998740
Why two NDCs? The FDA registers this code as 36800-861-01 — 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 → 36800-0861-01. 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

🧪 What is this product?

This is an over-the-counter coated tablet taken by mouth that contains docusate sodium and sennosides. Docusate sodium is a stool softener typically used to make stools easier to pass, while sennosides are a natural plant-based laxative commonly used to stimulate bowel movement. Together, these ingredients are used as an over-the-counter product in the laxative category under FDA's monograph rules for their ingredient class.

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
36800-0861-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE 2021-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Senexon-S 8.6 mg/1; 50 mg 00536-1247-01 RUGBY 100 tablets $0.030 — Availability likely —
Stimulant Laxative Plus Stool Softener 8.6 mg/1; 50 mg 00536-1248-01 RUGBY 100 tablets $0.030 — Availability likely —
Sennosides, Docusate Sodium 50 mg/1; 8.6 mg 00904-7440-61 Major 10 tablets $0.030 — Availability likely —
Senna Plus 50 mg/1; 8.6 mg 46122-0625-72 AmerisourceBergen 60 tablets $0.030 — Availability likely —
Stool Softener Laxative 50 mg/1; 8.6 mg 46122-0669-78 AmerisourceBergen 100 tablets $0.030 — Availability likely —
Sennosides and Docusate Sodium 8.6 mg/1; 50 mg 60687-0622-01 American 100 tablets $0.030 — Availability likely —
Senna Plus 8.6 mg/1; 50 mg 70000-0520-01 CARDINAL 30 tablets $0.030 — Availability likely —
Stool Softener plus Stimulant Laxative 8.6 mg/1; 50 mg 70000-0526-01 CARDINAL 100 tablets $0.030 — Availability likely —
Senna-S 8.6 mg/1; 50 mg 70677-1069-01 STRATEGIC 60 tablets $0.030 — Availability likely —
Stool Softener 50 mg/1; 8.6 mg 70677-1094-01 Strategic 100 tablets $0.030 — Availability likely —
Senna S 50 mg/1; 8.6 mg 83324-0135-60 QUALITY 60 tablets $0.030 — Availability likely —
Stool Softener 50 mg/1; 8.6 mg 83324-0136-01 QUALITY 100 tablets $0.030 — Availability likely —
Senna-S 50 mg/1; 8.6 mg 70677-1246-01 Strategic 100 tablets $0.032 — FDA listed —
Colace 50 mg/1; 8.6 mg 67618-0110-10 Atlantis 5 tablets $0.412 — Availability likely —
Senokot-S 8.6 mg/1; 50 mg 67618-0310-01 Atlantis 10 tablets $0.412 — Availability likely —
Stool Softener Laxative Plus Stimulant 50 mg/1; 8.6 mg 00363-0827-20 Walgreens 200 tablets — — FDA listed —
Senna S 50 mg/1; 8.6 mg 00363-0883-12 Walgreens 120 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 00363-8550-20 Walgreens 200 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 00363-8780-20 Walgreens 200 tablets — — Discontinued —
Senexon-S 8.6 mg/1; 50 mg 00615-8331-39 NCS 30 tablets — — FDA listed —
Senna-S Laxative With Stool Softener 50 mg/1; 8.6 mg 00761-0910-02 Basic 100 tablets — — FDA listed —
Senna S 8.6 mg/1; 50 mg 10135-0669-01 Marlex 100 tablets — — FDA listed —
Stool Softening Senna Laxative 50 mg/1; 8.6 mg 11673-0192-03 TARGET 30 tablets — — FDA listed —
Stool Softener And Stimulant Laxative 8.6 mg/1; 50 mg 11673-0209-01 TARGET 100 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 16103-0378-07 Pharbest 60 tablets — — FDA listed —
Stimulant Laxative Plus Stool Softener 8.6 mg/1; 50 mg 17856-1248-01 ATLANTIC 1 tablet — — FDA listed —
Natural Vegetable Laxative and Stool Softener 50 mg/1; 8.6 mg 21130-0219-03 BETTER 30 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 21130-0829-20 Safeway, 200 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 21130-0855-20 Safeway, 200 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 21130-0878-20 Safeway, 200 tablets — — FDA listed —
Senna S 50 mg/1; 8.6 mg 21130-0883-30 Safeway, 30 tablets — — FDA listed —
Stool Softener 8.6 mg/1; 50 mg 21130-0902-20 BETTER 200 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 36800-0084-01 TOP 100 tablets — — FDA listed —
Senna S 50 mg/1; 8.6 mg 36800-0783-12 TOP 120 tablets — — FDA listed —
Laxative Docusate Sodium with Senna 50 mg/1; 8.6 mgthis 36800-0861-01 TOPCO 100 tablets — — FDA listed —
Vegetable Laxative and Stool Softner 50 mg/1; 8.6 mg 36800-0938-60 TOPCO 60 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 37808-0355-12 H 120 tablets — — FDA listed —
Stool Softener and Stimulant Laxative 50 mg/1; 8.6 mg 37808-0549-29 H-E-B 240 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 37808-0878-12 H 120 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 41163-0755-10 United 100 tablets — — FDA listed —
Stool Softener Plus Stimulant 50 mg/1; 8.6 mg 41163-0778-10 United 100 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 41163-0829-10 United 100 tablets — — FDA listed —
Senna S 50 mg/1; 8.6 mg 41163-0883-30 United 30 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 41226-0192-06 KROGER 60 tablets — — FDA listed —
Stool Softener-Stimulant Laxative 8.6 mg/1; 50 mg 41226-0209-06 Kroger 60 tablets — — FDA listed —
Sool Softener Laxative 50 mg/1; 8.6 mg 49035-0270-30 EQUATE 30 tablets — — FDA listed —
Laxative and Stool Softener 50 mg/1; 8.6 mg 49035-0360-30 EQUATE 30 tablets — — FDA listed —
Senna Time S 50 mg/1; 8.6 min 49483-0081-00 TIME 100000 tablets — — FDA listed —
Sennosides And Docusate Sodium 8.6 mg/1; 50 mg 49483-0097-00 TIME 100000 tablets — — FDA listed —
Laxacin 50 mg/1; 8.6 mg 50488-0901-01 Alexso, 100 tablets — — FDA listed —
Stimulant Laxative Plus Stool Softener 8.6 mg/1; 50 mg 50804-0304-10 GOOD 100 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 50804-0855-10 Good 100 tablets — — Discontinued —
Senna S 50 mg/1; 8.6 mg 53329-0989-62 Medline 60 tablets — — FDA listed —
Drug Mart Vegetable Laxative plus Stool Softener 50 mg/1; 8.6 mg 53943-0153-01 Discount 100 tablets — — FDA listed —
Drug Mart Stool Softener plus Stimulant Laxative 50 mg/1; 8.6 mg 53943-0154-01 Discount 100 tablets — — FDA listed —
Senna S 50 mg/1; 8.6 mg 54257-0089-02 Magno-Humphries, 100 tablets — — FDA listed —
Sennosides, Docusate Sodium 50 mg/1; 8.6 mg 55154-0195-00 Cardinal 10 tablets — — FDA listed —
Sennosides and Docusate Sodium 8.6 mg/1; 50 mg 55154-2578-00 Cardinal 10 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 55319-0565-10 Family 100 tablets — — FDA listed —
Stool Softener Laxative Plus Stimulant 50 mg/1; 8.6 mg 55910-0829-10 Dolgencorp, 100 tablets — — FDA listed —
Stool Softener Laxative Plus Stimulant 50 mg/1; 8.6 mg 55910-0855-10 Dolgencorp, 100 tablets — — FDA listed —
Stool Softener Laxative Plus Stimulant 50 mg/1; 8.6 mg 55910-0978-10 Dolgencorp, 100 tablets — — FDA listed —
Stool Softener with Laxative 8.6 mg/1; 50 mg 57896-0304-01 Geri-Care 100 tablets — — FDA listed —
Senna Plus 8.6 mg/1; 50 mg 57896-0458-10 Geri-Care 1000 tablets — — FDA listed —
Senna-Plus 8.6 mg/1; 50 mg 57896-0555-01 Geri-Care 100 tablets — — FDA listed —
Stool Softener with Stimulant Laxative 50 mg/1; 8.6 mg 59726-0855-10 P 100 tablets — — FDA listed —
Stool Softener with Stimulant Laxative 50 mg/1; 8.6 mg 59726-0878-10 P 100 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 62011-0417-01 Strategic 100 tablets — — Discontinued —
Docusate Sodium and Sennosides 50 mg/1; 8.6 mg 62993-0002-01 Morepen 30 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 63561-0187-01 Granulation 100 tablets — — FDA listed —
Stool Softener Stimulant laxative 50 mg/1; 8.6 mg 63868-0875-01 QUALITY 100 tablets — — FDA listed —
Stool Softener plus Laxative 50 mg/1; 8.6 mg 63868-0878-60 QUALITY 60 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 63868-0884-01 QUALITY 100 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 63868-0946-01 QUALITY 100 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 63941-0855-10 Best 100 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 63941-0878-10 Best 100 tablets — — FDA listed —
Stool Softener with laxative 50 mg/1; 8.6 mg 67091-0328-60 WinCo 60 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 67091-0373-60 WinCo 60 tablets — — FDA listed —
Stimulant Laxative Plus Stool Softener 8.6 mg/1; 50 mg 68788-7674-01 Preferred 100 tablets — — FDA listed —
Senna-Plus 8.6 mg/1; 50 mg 68788-8780-01 Preferred 100 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 69517-0131-02 HealthLife 2 tablets — — FDA listed —
Sennosides and Docusate Sodium 8.6 mg/1; 50 mg 69618-0065-01 Reliable-1 100 tablets — — FDA listed —
Colon Detox 50 mg/1; 8.6 mg 69729-0151-60 OPMX 60 tablets — — FDA listed —
Laxative Stool Softener 50 mg/1; 8.6 mg 69842-0776-18 CVS 180 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 69842-0881-10 CVS 100 tablets — — FDA listed —
Senna Plus 50 mg/1; 8.6 mg 69842-0883-18 CVS 180 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 69842-0887-10 CVS 100 tablets — — FDA listed —
Docuzen 8.6 mg/1; 50 mg 71205-0282-30 Proficient 30 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 71205-0970-00 Proficient 100 tablets — — FDA listed —
Senna-Plus 8.6 mg/1; 50 mg 71335-1674-01 Bryant 30 tablets — — FDA listed —
Stool Softener with Laxative 8.6 mg/1; 50 mg 71335-2522-01 Bryant 30 tablets — — FDA listed —
Stimulant Laxative Plus Stool Softener 8.6 mg/1; 50 mg 71335-2693-01 Bryant 30 tablets — — FDA listed —
Docuzen 8.6 mg/1; 50 mg 71574-0700-60 Village 60 tablets — — FDA listed —
Senna-S 50 mg/1; 8.6 mg 72090-0030-20 Pioneer 200 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 72476-0855-10 Care 100 tablets — — FDA listed —
Stool Softener Plus Stimulant Laxative 50 mg/1; 8.6 mg 72476-0878-10 Care 100 tablets — — FDA listed —
Senna S Orange 50 mg/1; 8.6 mg 72476-0883-60 Care 60 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 73057-0378-07 Ulai 60 tablets — — FDA listed —
Sennosides and Docusate Sodium 8.6 mg/1; 50 mg 76420-0918-01 Asclemed 100 tablets — — FDA listed —
Stool Softener plus Stimulant Laxative 8.6 mg/1; 50 mg 79481-0304-01 Meijer, 100 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 79481-0555-06 Meijer, 60 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 79903-0009-12 WALMART 120 tablets — — FDA listed —
Senna-Plus 50 mg/1; 8.6 mg 80136-0555-01 Heartland 100 tablets — — Discontinued —
Laxacin 50 mg/1; 8.6 mg 80425-0345-01 Advanced 100 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 80513-0105-25 Advanced 250 tablets — — FDA listed —
Senna With Docusate Sodium 8.6 mg/1; 50 mg 83586-0001-00 HHH 50000 tablets — — FDA listed —
Senna-S 50 mg/1; 8.6 mg 84324-0013-01 NUVICARE 100 tablets — — FDA listed —
Senna-S 8.6 mg/1; 50 mg 85111-0455-10 RMT 1000 tablets — — FDA listed —
Healix Senna-S 8.6 mg/1; 50 mg 87275-2451-01 Brainstorm 100 tablets — — FDA listed —
Stool Softener Laxative 50 mg/1; 8.6 mg 59726-0778-10 P 100 tablets — — Discontinued —
Docusate Sodium and Sennosides 50 mg/1; 8.6 mg 87717-0502-01 Morepen 1000 tablets — — 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

🏛️
2021
On the market since
May 2021
📍
2026
Currently FDA-listed
5 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

LabelerTOPCO ASSOCIATES LLC
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedMay 2021
Product typeHuman Otc Drug
Portfolio408 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

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

⏱️ Dosage and Administration 67 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 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 years ask a doctor

⚠️ Warnings 122 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 Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues over a period of 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 may indicate 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 19 words ▾

Other information • each tablet contains: calcium 20 mg, sodium 3 mg (low sodium) • store between 20-25°C (68-77°F)

🧪 Active Ingredient 12 words ▾

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

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

🎯 Purpose 5 words ▾

Purposes Stool softener Stimulant laxative

📄 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 3 words ▾

Questions? Call 1-888-423-0139

📄 Package Label / Principal Display Panel 2 words ▾

Packaging 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 Laxative Docusate Sodium with Senna (this brand).

Top reported reactions

Vomiting3
Abdominal Distension2
Abdominal Pain Upper2
Death2
Memory Impairment2
Oxygen Saturation Decreased2
Abdominal Pain1

Reporter sex

8 reports
Male · 38%
Female · 63%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1 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 — Not published for this NDC No photo available yet for this listing.
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 TOPCO ASSOCIATES LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TOPCO ASSOCIATES LLC 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.
← 36800-0860-05 · Topco 36800-0863-78 · Topco →
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.