STOOL SOFTENER docusate sodium 100 mg Tablet, 200-count
by Geri-Care Pharmaceuticals, Corp · 200 TABLET in 1 BOTTLE (57896-421-20)
NDC 57896-0421-20
🏷️ FDA NDC (as labeled)
57896-421-20
billing pads the product segment with a zero
This package
Contains200-count
Pack sizes3 compare ↓
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 →
🆔 Identity & classification
FDA NDC (as labeled)
57896-421-20
Product NDC
57896-421
11-digit billing NDC
57896042120
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
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
Why two NDCs?
The FDA registers this code as 57896-421-20 — 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 → 57896-0421-20. 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.
🏭 Manufacturer & labeler
LabelerGeri-Care Pharmaceuticals, Corp
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code57896
First marketedSep 2015
Product typeHuman Otc Drug
Portfolio47 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
Label name STOOL SOFTENER 100 MG TABLET Ingredient Docusate Sodium
📖 About the active ingredient: Docusate Sodium MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.
Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.
Read the full MedlinePlus article ↗🧪 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.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Docusate Sodium — tap one for details:
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.
💬 Questions about docusate sodium?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeRound
ImprintGC422
Size11 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 L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
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 OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
7 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesmicrocrystalline cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, sodium benzoate, stearic acid
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 system | Per each | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 57896-0421-20 | Geri-Care | 200 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.
🔬 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 Stool Softener (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 42%
Female · 58%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 57896-0421-01 | 100 TABLET in 1 BOTTLE (57896-421-01) | 2015-09-01 | Active |
| 57896-0421-10 | 1000 TABLET in 1 BOTTLE (57896-421-10) | 2015-09-01 | Active |
| 57896-0421-20 You're viewing this | 200 TABLET in 1 BOTTLE (57896-421-20) | 2019-05-01 | Active |
You're viewing one of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 57896-0421-20?
NDC 57896-0421-20 is a 200-count package — 200 tablet in 1 bottle.
What is the difference between NDC 57896-0421-20 and NDC 57896-0421-01?
Both are STOOL SOFTENER docusate sodium 100 mg Tablet — the drug itself is identical. NDC 57896-0421-20 is the 200-count package, while NDC 57896-0421-01 is the 100 tablets package.
What NDC number is used to bill for this package of STOOL SOFTENER docusate sodium 100 mg Tablet?
Bill NDC 57896-0421-20 — the 11-digit billing format is 57896042120. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 57896-421-20, 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: 57896-0421-20, written without dashes as 57896042120. 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 57896-0421-20, the first segment (57896) is the labeler code FDA assigned to Geri-Care Pharmaceuticals, Corp; the middle segment (0421) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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 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 100 tablets (57896-0421-01), 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.
📄 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 ▾
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
⏱️ Dosage and Administration ▾
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 ▾
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 ▾
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 ▾
Active ingredient Docusate Sodium 100 mg
🧪 Inactive Ingredients ▾
Inactive ingredients microcrystalline cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, sodium benzoate, stearic acid
🎯 Purpose ▾
Purpose Stool Softener
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.