Docusate Sodium Liquid 50 mg/5mL Liquid, 473 mL
by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION · 473 mL in 1 BOTTLE (54859-813-16)
NDC 54859-0813-16
🏷️ FDA NDC (as labeled)
54859-813-16
billing pads the product segment with a zero
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)
54859-813-16
Product NDC
54859-813
11-digit billing NDC
54859081316
NCPDP billing unit
ML — per mL (volume)
RxCUI
1248119
UNII
F05Q2T2JA0
Application #
M007
SPL Set ID
2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-12-01
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 SODIUM 50 MG/5 ML LIQ
FDB brand name
Docusate Sodium
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 54859-813-16 — 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 → 54859-0813-16. 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
LabelerLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code54859
First marketedDec 2021
Product typeHuman Otc Drug
Portfolio11 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 DOCUSATE SODIUM 50 MG/5 ML LIQ 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 oral liquid containing docusate sodium, a stool softener. Docusate sodium is typically used to help soften stool and make bowel movements easier, particularly for people who want to avoid straining. This product is marketed as an OTC monograph drug, meaning it follows FDA category rules for stool softeners rather than being individually reviewed. The liquid form allows flexible dosing and is commonly given to those who have difficulty swallowing pills.
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.
🧪 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 WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
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 1S66E28KXA
Poloxamer 124 is a synthetic polymer that acts as a surfactant and solubilizer in medicines. It helps dissolve and stabilize active ingredients, particularly in liquid formulations and gels.
-
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
-
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 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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
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 statesInactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, 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 | $0.020 | $9.65 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0470 | $22.23 / 473 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per mL) — tap or hover for the price & month
▼ Down 5% over the last 9 months.
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/5mLthis 54859-0813-16 | LLORENS | 473 ml | $0.020 | — | Availability likely | — |
| Docusate Sodium 50 mg/5mL 00121-0935-16 | PAI | 473 ml | $0.021 | — | Discontinued | +4% |
| 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/10mL 81033-0022-50 | Kesin | 100 cups | — | — | FDA listed | — |
| Docusate Sodium 100 mg/10mL 84447-0011-01 | Belleview | 200000 ml | — | — | FDA listed | — |
| Docusate Sodium 50 mg/5mL 55154-2346-05 | Cardinal | 5 cups | — | — | 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
Dec 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 54859-0813-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
170
Units reimbursed last 4 qtrs
67K
Gross reimbursed last 4 qtrs
$3.1K
Avg / prescription
$18.50
Avg / unit
$0.0470
Latest quarter Q1 2026
110Rx
Medicaid pays / mL
$0.0470
gross reimbursed
vs
NADAC / mL
$0.0204
acquisition cost
=
Spread
+$0.0266
+130% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 159 Rx Managed care · 11 Rx
State Medicaid map
Units reimbursed · per 100k residents
57.8144
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🔬 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 Docusate Sodium Liquid (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 43%
Female · 56%
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 |
|---|---|---|---|
| 54859-0813-16 You're viewing this | 473 mL in 1 BOTTLE (54859-813-16) | 2021-12-01 | Active |
📄 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses Relief of occasional constipation
⏱️ Dosage and Administration ▾
Directions follow dosing directions below or use as directed by a physician must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation may be taken as a single daily dose or in dividend dose take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response do not exceed recommended dose shake well before using 1 teasponnful = 5 mL Age Dose Adults and children over 12 years of age 1 to 6 teaspoons (50 mg - 300 mg) Children under 12 years of age Ask a doctor
⚠️ Warnings ▾
Warnings Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor for more than one week unless directed by a doctor Ask a doctore before use if you are taking mineral oil have noticed a sudden change in bowel habits that last more than two weeks Stop use and ask doctor if you have no bowel movements within 3 days you have rectal bleeding these could be signs of a serious condition a skin rash occurs you experience throat irritation
🧪 Active Ingredient ▾
Active Ingredients (per 5 mL) Docusate Sodium 50 mg
🧪 Inactive Ingredients ▾
Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose
🎯 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.