NDC 81033-0022-50 — Docusate Sodium Oral Liquid 100 mg/10mL Liquid

🆔 Identity & classification

FDA NDC (as labeled) 81033-022-50

Product NDC 81033-022

11-digit billing NDC 81033002250

NCPDP billing unit ML — per mL (volume)

RxCUI 1248119

UNII F05Q2T2JA0

Application # M007

SPL Set ID 331277b8-8304-d082-e063-6394a90a4dd3

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-04-01

Route ORAL

Dosage form LIQUID

Substance DOCUSATE SODIUM

GCN Seq No 003017

GCN 09131

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 DOCUSATE SOD 100 MG/10 ML CUP

FDB brand name Docusate Sodium

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 81033-022-50 — 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 → 81033-0022-50. 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

LabelerKesin Pharma Corporation

FDA applicationM007 (OTC MONOGRAPH DRUG)

Labeler code81033

First marketedApr 2025

Product typeHuman Otc Drug

Portfolio37 products on file

🔎 All NDCs from Kesin Pharma Corporation

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 DOCUSATE SOD 100 MG/10 ML CUP 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 liquid taken by mouth that contains docusate sodium, a stool softener. Docusate sodium is typically used to make bowel movements easier by softening stool and increasing water in the intestines. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for stool softeners rather than undergoing individual approval review.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

FlavorGrape

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 3VRD35U26C
A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
UNII 6X543N684K
A natural flavoring derived from grapes that enhances taste appeal. It's used in medicines to improve flavor and make medications more palatable, especially for children or patients who need better taste acceptance.
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII EE90ONI6FF
Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescitric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

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 mL	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
Docusate Sodium Liquid 50 mg/5mL 00536-1304-85	RUGBY	473 ml	$0.020	—	Availability likely	—
Docusate Sodium Liquid 50 mg/5mL 54859-0813-16	LLORENS	473 ml	$0.020	—	Availability likely	—
Walgreens Stool Softener Fruit Punch 50 mg/5mL 00363-7140-08	WALGREENS	237 ml	—	—	FDA listed	—
Kroger Stool Softener Fruit Punch 50 mg/5mL 41226-0714-08	KROGER	237 ml	—	—	FDA listed	—
Docusate Sodium 50 mg/5mL 48433-0220-10	Safecor	10 ml	—	—	FDA listed	—
GeriCare Docusate Sodium Liquid 50 mg/5mL 57896-0413-16	GERI-CARE	473 ml	—	—	FDA listed	—
GeriCare Docusate Sodium Liquid 50 mg/5mL 57896-0423-16	GERI-CARE	473 ml	—	—	FDA listed	—
CVS Stool Softener Fruit Punch 50 mg/5mL 69842-0714-08	CVS	237 ml	—	—	FDA listed	—
Docusate Sodium Oral Liquid 100 mg/10mLthis 81033-0022-50	Kesin	100 cups	—	—	FDA listed	—
Docusate Sodium 100 mg/10mL 84447-0011-01	Belleview	200000 ml	—	—	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

🏛️

2025

On the market since

Apr 2025

📍

2026

Currently FDA-listed

1 year 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
81033-0022-50 You're viewing this	100 CUP, UNIT-DOSE in 1 CASE (81033-022-50) / 10 mL in 1 CUP, UNIT-DOSE (81033-022-10)	2025-04-01	Active

🧭 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 81033-022-50, 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: 81033-0022-50, written without dashes as 81033002250. 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 81033-0022-50, the first segment (81033) is the labeler code FDA assigned to Kesin Pharma Corporation; the middle segment (0022) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Kesin Pharma Corporation. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Kesin Pharma Corporation 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 15 words ▾

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

⏱️ Dosage and Administration 104 words ▾

Directions shake well before using must be given in a 6 oz to 8 oz glass of milk, fruit juice or infant formula to mask the bitter taste and prevent throat irritation take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response do not exceed recommended dose follow dosing directions below or use as directed by a doctor 1 teaspoonful = 5 mL Age Dose adults and children 12 years and older 1 to 7 teaspoonfuls children 2 to under 12 years of age 1 to 3 teaspoonfuls children under 2 years of age ask a doctor

⚠️ Warnings 92 words ▾

Warnings Do not use for more than 1 week unless directed by a doctor if you are currently taking mineral oil, 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 persists over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of a laxative. These could be signs of a serious condition. a skin rash occurs you experience throat irritation

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 5mL) Docusate Sodium 100 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

🎯 Purpose 4 words ▾

Purpose Stool Softener Laxative

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

🔗 Related NDC lookups

🧪 All Docusate Sodium Oral Liquid NDCsSame ingredient 🏭 All Kesin labeler NDCsLabeler code 81033

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Laxatives And Cathartics.

Sennosides 00067-8140-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.