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Topcare Stool Softener Docusate Sodium 100 mg Capsule, Liquid Filled, 400-count — NDC 76162-0006-81 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Topcare Stool Softener Docusate Sodium 100 mg Capsule, Liquid Filled, 400-count — NDC 76162-006-81 (Billing 76162-0006-81)

by TopCo Associates, LLC · 400 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 400 capsules of Topcare Stool Softener Docusate Sodium 100 mg Capsule, Liquid Filled from TopCo Associates, LLC, marketed since Apr 2015 and currently FDA-listed.

NDC 76162-0006-81
🏷️ FDA NDC (as labeled) 76162-006-81 billing pads the product segment with a zero
This package
Contains400-count Pack sizes3 compare ↓
Product page 76162-0006-01 Also comes in: 60 capsules 76162-006-60 100 capsules 76162-006-01
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

NDC database record

One package, one record: these facts belong to NDC 76162-006-81 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76162 labeler · 006 product · 81 package
Package marketed since
Apr 10, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7616200681 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76162-006-81
Product NDC 76162-006
11-digit billing NDC 76162000681
RxCUI 1115005
UNII F05Q2T2JA0
Application # M007
SPL Set ID 6f4fddda-4129-4087-b0e4-ababc5558484
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-04-10
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DOCUSATE SODIUM
Quick answers
  • RxCUI (RxNorm): 1115005
Why two NDCs? The FDA registers this code as 76162-006-81 — 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 → 76162-0006-81. 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

🧪 What is this product?

Topcare Stool Softener is an over-the-counter liquid-filled capsule taken by mouth. It contains docusate sodium, which is a stool softener typically used to help make bowel movements easier by softening stool. This product is marketed as an OTC monograph drug, meaning it follows established safety and use guidelines for this class of medication rather than being individually reviewed by the FDA.

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: 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 Marketing startMarketing endStatus
76162-0006-01 76162-006-01 Main listing 100 CAPSULE, LIQUID FILLED in 1 BOTTLE 2015-04-10 — Active
76162-0006-60 76162-006-60 1 BOTTLE in 1 CARTON / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE 2015-04-10 — Active
76162-0006-81 You're viewing this 400 CAPSULE, LIQUID FILLED in 1 BOTTLE 2015-04-10 — Active

Pack size FAQ

What quantity is in this package?
This is a 400-count package — 400 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 76162-0006-60?
Both are Topcare Stool Softener Docusate Sodium 100 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 400-count one, while NDC 76162-0006-60 is the 60 capsules package.
What NDC number is used to bill for this package of Topcare Stool Softener Docusate Sodium 100 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense stool softener 100 mg 00113-0486-72 L. 60 capsules $0.022 — Discontinued —
Quality Choice Stool Softener 100 mg 63868-0585-01 Chain 100 capsules $0.022 — FDA listed —
Stool Softener Laxative 100 mg 62011-0421-01 Strategic 100 capsules $0.024 — Discontinued —
Stool Softener Laxative 100 mg 70677-0034-01 Strategic 100 capsules $0.024 — Discontinued —
Docusate Sodium - Stool Softener Laxative 100 mg 00904-7183-61 Major 10 capsules $0.028 — Availability likely —
Stool Softener Laxative 100 mg 00904-7280-60 Major 100 capsules $0.028 — Availability likely —
Docusate sodium 100 mg 24689-0130-01 APNAR 100 capsules $0.028 — Availability likely —
Docusate Sodium 100 mg 45802-0486-78 Padagis 100 capsules $0.028 — Availability likely —
Good Neighbor Stool Softener 100 mg 46122-0692-72 AmerisourceBergen 60 capsules $0.028 — Availability likely —
Docusate Sodium 100 mg 60687-0129-01 American 1 capsule $0.028 — Availability likely —
Stool Softener Laxative 100 mg 70000-0091-01 CARDINAL 100 capsules $0.028 — Availability likely —
Stool Softener Laxative 100 mg 70677-1095-01 Strategic 100 capsules $0.028 — Availability likely —
Colace 100 mg 67618-0101-01 Atlantis 100 capsules $0.306 — Availability likely —
Fleet 100 mg 00132-0402-25 C.B. 25 capsules — — FDA listed —
Phillips Stool Softener Bulk Docusate 100 mg 00280-1012-30 Bayer 30 capsules — — FDA listed —
Gentle Stool Softener 100 mg 00363-1172-25 WALGREEN 25 capsules — — FDA listed —
Gentle Stool Softener 100 mg 00363-1179-25 WALGREEN 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-4100-20 Walgreens 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-4202-30 Walgreens 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-7111-10 Walgreens 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-8530-20 Walgreens 200 capsules — — FDA listed —
Stool Softener 100 mg 00363-8540-30 Walgreens 30 capsules — — FDA listed —
Docusate Sodium 100 mg 00363-8991-25 WALGREEN 25 capsules — — FDA listed —
Stool Softener 100 mg 00363-9944-20 Walgreen 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00615-8557-39 NCS 30 capsules — — FDA listed —
Docusate Sodium 100 mg 00904-7609-61 Major 1 capsule — — FDA listed —
Preferred Stool Softener 100 mg 10956-0621-00 Reese 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0341-16 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0512-66 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0678-16 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0853-16 TARGET 160 capsules — — FDA listed —
Docusate Sodium 100 mg 16103-0399-08 Pharbest 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 21130-0041-20 Safeway, 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 21130-0853-20 Safeway, 200 capsules — — FDA listed —
Stool Softener 100 mg 30142-0407-01 KROGER 100 capsules — — Discontinued —
Stool Softener Laxative 100 mg 30142-0451-25 The 250 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0553-25 The 250 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0778-10 The 100 capsules — — Discontinued —
Stool Softener Laxative 100 mg 36800-0638-10 TOP 100 capsules — — FDA listed —
Stool Softener 100 mg 36800-0651-25 TOP 25 capsules — — FDA listed —
Stool Softener 100 mg 37808-0580-01 HEB 100 capsules — — FDA listed —
Stool Softener 100 mg 37808-0582-01 HEB 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 37808-0853-30 H 300 capsules — — FDA listed —
Stool Softener Laxative 100 mg 37808-0862-10 H 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0107-25 United 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0241-10 United 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0853-10 United 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0862-25 United 25 capsules — — FDA listed —
Dulcolax Stool Softener 100 mg 41167-0221-02 Chattem, 25 capsules — — FDA listed —
Dulcolax Pink Stool Softener 100 mg 41167-0281-01 Chattem, 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 49035-0385-50 EQUATE 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 49035-0526-14 EQUATE 140 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-5524-01 A-S 100 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-6140-01 A-S 100 capsules — — FDA listed —
Stool Softener 100 mg 50090-7167-01 A-S 100 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-7479-01 A-S 100 capsules — — FDA listed —
Stool Softener 100 mg 50804-0424-25 Good 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 50804-0701-25 Good 25 capsules — — FDA listed —
Stool Softener 100 mg 51013-0819-01 PuraCap 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 51316-0107-10 CVS 100 capsules — — FDA listed —
Docusate Sodium 100 mg 53345-0008-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53345-0018-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53345-0023-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg 100 mg 53345-0029-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53943-0250-10 Discount 100 capsules — — FDA listed —
Stool Softener Docusate Sodium 100 mg 54257-0902-02 Magno-Humphries, 100 capsules — — FDA listed —
Docusate Sodium - Stool Softener Laxative 100 mg 55154-3369-00 Cardinal 1 capsule — — FDA listed —
Docusate Sodium 100 mg 55289-0493-12 PD-Rx 12 capsules — — FDA listed —
exchange select stool softener 100 mg 55301-0486-78 Army 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55319-0561-10 Family 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0048-10 Dolgencorp, 100 capsules — — FDA listed —
Stool Softener 100 mg 55910-0762-50 Dolgencorp, 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0853-10 Dolgencorp, 100 capsules — — FDA listed —
Stool Softener 100 mg 55910-0938-25 Dolgencorp, 25 capsules — — FDA listed —
Stool Softener 100 mg 55910-0939-20 Dolgencorp, 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0968-40 Dolgencorp, 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 56062-0241-10 Publix 100 capsules — — FDA listed —
Stool Softener 100 mg 57896-0401-01 Geri-Care 100 capsules — — FDA listed —
Stool Softener 100 mg 57896-0411-01 Geri-Care 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0141-01 P 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0142-01 P 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0852-01 P 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0853-01 P 1000 capsules — — FDA listed —
Docusate Sodium 100 mg 63187-0476-00 Proficient 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63868-0638-25 QUALITY 250 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63941-0853-10 Best 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63981-0853-40 Costco 400 capsules — — FDA listed —
Docusate Sodium 100 mg 66267-0888-30 NuCare 30 capsules — — FDA listed —
Winco Stool Softener 100 mg 67091-0366-10 WinCo 100 capsules — — FDA listed —
Winco Stool Softener 100 mg 67091-0380-25 WinCo 25 capsules — — FDA listed —
Docusate Sodium 100 mg 68071-2874-00 NuCare 100 capsules — — FDA listed —
Docusate Sodium 100 mg 68071-3438-06 NuCare 60 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68071-3784-00 NuCare 100 capsules — — FDA listed —
Stool Softener 100 mg 68196-0853-60 Sam's 600 capsules — — FDA listed —
Docusate Sodium 100 mg 68196-0995-64 Sam's 600 capsules — — FDA listed —
Stool Softener Regular Strength 100 mg 68196-0998-60 Sam's 600 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68391-0041-40 BJWC 400 capsules — — FDA listed —
Stool Softener 100 mg 68391-0730-40 BJWC 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68391-0853-40 BJWC 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68788-8501-01 Preferred 100 capsules — — FDA listed —
Docusate Sodium 100 mg 68788-8658-03 Preferred 30 capsules — — FDA listed —
Stool Softener 100 mg 68788-8919-01 Preferred 100 capsules — — FDA listed —
Stool Softener 100 mg 68998-0420-01 Marc 100 capsules — — FDA listed —
Stool Softener 100 mg 69168-0420-01 Allegiant 100 capsules — — FDA listed —
Stool Softener 100 mg 69168-0424-32 Allegiant 100 capsules — — FDA listed —
Stool Softener 100 mg 69618-0086-01 Reliable 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0317-30 CVS 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0579-30 CVS 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0782-10 CVS 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0794-10 CVS 100 capsules — — FDA listed —
Stool Softener 100 mg 69842-0861-10 CVS 100 capsules — — FDA listed —
Stool Softener 100 mg 69842-0862-10 CVS 100 capsules — — Discontinued —
Stool Softener Laxative 100 mg 69842-0893-30 CVS 30 capsules — — FDA listed —
Stool Softener 100 mg 71335-0294-00 Bryant 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 71335-9731-00 Bryant 18 capsules — — FDA listed —
Stool Softener 100 mg 72162-2255-01 Bryant 100 capsules — — FDA listed —
basic care stool softener 100 mg 72288-0486-78 Amazon.com 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0041-10 Care 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0107-25 Care 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0853-10 Care 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0862-25 Care 25 capsules — — FDA listed —
Docusate Sodium 100 mg 72789-0399-30 PD-Rx 30 capsules — — FDA listed —
Topcare Stool Softener 100 mgthis 76162-0006-81 TopCo 400 capsules — — FDA listed —
Topcare Stool Softener 100 mg 76162-0761-25 TOPCO 25 capsules — — FDA listed —
Topcare Stool Softener 100 mg 76162-0777-99 TOPCO 250 capsules — — FDA listed —
Docusate Sodium 100 mg 76420-0225-30 Asclemed 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 79481-0853-01 Meijer 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 79903-0170-50 WALMART 50 capsules — — FDA listed —
Docusate Sodium 100 mg 81877-0840-90 Forreal 90 capsules — — FDA listed —
FEVIA Constipation Control 100 mg 82706-0029-01 VIVUNT 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 82804-0097-00 Proficient 100 capsules — — FDA listed —
Quality Choice Stool Softener 100 mg 83324-0197-01 Chain 100 capsules — — FDA listed —
Stool Softener 100 mg 85111-0401-10 RMT 1000 capsules — — FDA listed —
Docusate Sodium 100Mg 100 mg 85786-0502-24 Farmacias 24 capsules — — FDA listed —
HEB Stool Softener 100 mg 37808-0222-52 H 100 capsules — — FDA listed —
HEB Stool Softener 100 mg 37808-0457-52 H 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0280-10 The 100 capsules — — FDA listed —
stool softener 100 mg 72288-0035-78 Amazon.com 100 capsules — — FDA listed —
Docusate Sodium 100 mg 55154-0578-00 Cardinal 1 capsule — — FDA listed —
MiraSOFT Stool Softener 100 mg 11523-8259-03 Bayer 30 capsules — — FDA listed —
HyVee Regular Strength Stool Softener SOFTGEL 100 mg 42507-0108-01 HyVee 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

🏛️
2015
On the market since
Apr 2015
📍
2026
Currently FDA-listed
11 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 red / white
ShapeOval
ImprintPC18
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.

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 code76162
First marketedApr 2015
Product typeHuman Otc Drug
Portfolio59 products on file

More NDCs from TopCo Associates, LLC labeler code 76162

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 49 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 1-3 softgels daily Children 2 to under 12 years of age : Take 1 softgel daily Children under 2 years: Ask a doctor

⚠️ Warnings 120 words ▾

Warnings Do not use 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 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 could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 10 words ▾

Storage store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

🧪 Active Ingredient 5 words ▾

Active ingredient(s) Docusate sodium 100mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

🎯 Purpose 3 words ▾

Purpose Stool softener

📄 Do Not Use 18 words ▾

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

📄 Ask a Doctor Before Use If 27 words ▾

Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks

📄 Stop Use and Ask a Doctor If 44 words ▾

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. you need to use a stool softener laxative for more than 1 week

🤰 If Pregnant or Breast-Feeding 7 words ▾

Pregnancy/Breastfeeding ask a health professional before use.

📄 Keep Out of Reach of Children 23 words ▾

Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 7 words ▾

Questions Call 1-888-952-0050 Monday through Friday 9am-5pm

📄 Package Label / Principal Display Panel 11 words ▾

Principal Display Panel Stool Softener Stool Softener Stool Softener Stool Softener

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 Topcare Stool Softener (this brand).

Top reported reactions

Nausea1,623
Fatigue1,592
Dyspnoea1,398
Constipation1,226
Diarrhoea1,225
Vomiting1,192
Pain1,170

Age at onset

Neonate10
Infant19
Child23
Adolescent33
Adult1,419
Elderly1,750

Reporter sex

0 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization9,622
Death2,787
Life-threatening1,214
Disabling800
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,734 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 ✓ 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 TopCo Associates, LLC. 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 2 other package presentations of this same product, including 60 capsules (76162-0006-60), 100 capsules (76162-0006-01). 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?
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.
← 76162-0005-98 · TopCo 76162-0007-05 · 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.