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Stool Softener docusate sodium 100 mg Tablet, 100-count — NDC 57896-0421-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Stool Softener docusate sodium 100 mg Tablet, 100-count — NDC 57896-421-01 (Billing 57896-0421-01)

by Geri-Care Pharmaceuticals, Corp · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Stool Softener docusate sodium 100 mg Tablet from Geri-Care Pharmaceuticals, Corp, marketed since Sep 2015 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 57896-0421-01
🏷️ FDA NDC (as labeled) 57896-421-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Main listing for product 57896-421 · Also comes in: 200 tablets 57896-421-20 1000 tablets 57896-421-10
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 57896-421-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57896 labeler · 421 product · 01 package
Package marketed since
Sep 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC)
0357896421014
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57896-421-01
Product NDC 57896-421
11-digit billing NDC 57896042101
NCPDP billing unit EA — each (per item)
RxCUI 1099279
UNII F05Q2T2JA0
UPC 0357896421014
Application # M007
SPL Set ID 3ec42148-6786-22f2-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-01
Route ORAL
Dosage form TABLET
Substance DOCUSATE SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 46500010300305
GPI class Stool Softener
GCN Seq No 003020
GCN 09171
HICL code 001326
Ingredient (HICL) Docusate Sodium
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6S
Therapeutic class — specific (HIC3) Laxatives And Cathartics
AHFS code 56:12.00.00
AHFS class Cathartics And Laxatives
FDB label name STOOL SOFTENER 100 MG TABLET
FDB brand name Stool Softener
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 003020
  • GCN: 09171
  • GPI-14 (Medi-Span): 46500010300305
  • HICL (First Databank): 001326
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 1099279
Why two NDCs? The FDA registers this code as 57896-421-01 — 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 → 57896-0421-01. 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 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

Label name STOOL SOFTENER 100 MG TABLET Ingredient Docusate Sodium
🧪 What is this product?

This is an over-the-counter tablet containing docusate sodium, a stool softener sold under FDA's monograph rules for nonprescription use. Docusate sodium is typically used to help soften stool and make bowel movements easier, commonly taken by mouth to relieve occasional constipation. This product is not individually approved by the FDA but is marketed as part of a category of established over-the-counter medicines.

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.
Try another pack size: 200 tablets 1000 tablets
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
57896-0421-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2015-09-01 — Active
57896-0421-10 57896-421-10 1000 TABLET in 1 BOTTLE 2015-09-01 — Active
57896-0421-20 57896-421-20 200 TABLET in 1 BOTTLE 2019-05-01 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 57896-0421-20?
Both are Stool Softener docusate sodium 100 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 57896-0421-20 is the 200 tablets package.
What NDC number is used to bill for this package of Stool Softener docusate sodium 100 mg Tablet?
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
Dok 100 mg 00904-6750-60 MAJOR 100 tablets $0.039 — Availability likely —
Stool Softener 100 mg 70677-1071-01 STRATEGIC 100 tablets $0.039 — Availability likely —
Stool Softener 100 mgthis 57896-0421-01 Geri-Care 100 tablets — — FDA listed —
Stool Softener 100 mg 70677-1318-01 STRATEGIC 100 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

🏛️
2015
On the market since
Sep 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.

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

LabelerGeri-Care Pharmaceuticals, Corp
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code57896
First marketedSep 2015
Product typeHuman Otc Drug
Portfolio47 products on file

More NDCs from Geri-Care Pharmaceuticals, Corp labeler code 57896

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 14 words ▾

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

⏱️ Dosage and Administration 41 words ▾

Directions do not exceed recommended dose adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses. children under 12: ask a doctor

⚠️ Warnings 80 words ▾

Warnings Ask a doctor before use if you have stomach pain, nausea or vomiting have a sudden change in bowel habits that persists over a period of 2 weeks are presently taking mineral oil Stop use and ask a doctor if you need to use a laxative longer than 1 week you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.

📦 Storage and Handling 31 words ▾

Other information each tablet contains: calcium 50 mg, sodium 10 mg store at room temperature 15°C-30°C (59°F-86°F) Tamper Evident: Do not use if imprinted seal under cap is missing or broken

🧪 Active Ingredient 6 words ▾

Active ingredient Docusate Sodium 100 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients microcrystalline cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, sodium benzoate, stearic acid

🎯 Purpose 3 words ▾

Purpose Stool Softener

📄 Keep Out of Reach of Children 28 words ▾

Keep out of reach of children Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-540-3765

📄 Package Label / Principal Display Panel 3 words ▾

PACKAGE LABEL 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Geri-Care Pharmaceuticals, Corp. 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 200 tablets (57896-0421-20), 1000 tablets (57896-0421-10). 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?
Geri-Care Pharmaceuticals, Corp 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.
← 57896-0413-16 · GERI-CARE 57896-0423-16 · GERI-CARE →
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.