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Docusate Sodium Liquid 50 mg/5mL Liquid, 473 mL — NDC 0536-1304-85 (Billing 00536-1304-85)

by RUGBY LABORATORIES · 473 mL in 1 BOTTLE

This is a package of 473 mL of Docusate Sodium Liquid 50 mg/5mL Liquid from RUGBY LABORATORIES, marketed since Oct 2020 and currently FDA-listed; retail pharmacies pay about $0.0201 per mL (NADAC). It is this product's only package size.

NDC 00536-1304-85
🏷️ FDA NDC (as labeled) 0536-1304-85 billing pads the labeler segment with a zero
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 0536-1304-85 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1304 product · 85 package
Package marketed since
Oct 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC-A, from the NDC)
3 0536130485 0
Medicaid fills, this package
31,918 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1304-85
Product NDC 0536-1304
11-digit billing NDC 00536130485
NCPDP billing unit ML — per mL (volume)
RxCUI 1248119
UNII F05Q2T2JA0
Application # M007
SPL Set ID e21d19d8-6c2d-4474-a663-dfe7e91ac320
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-01
Route ORAL
Dosage form LIQUID
Substance DOCUSATE SODIUM

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

GPI-14 46500010300910
GPI class 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
Quick answers
  • GSN (GCN sequence number): 003017
  • GCN: 09131
  • GPI-14 (Medi-Span): 46500010300910
  • HICL (First Databank): 001326
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 1248119
Why two NDCs? The FDA registers this code as 0536-1304-85 — a 4-4-2 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 labeler segment → 00536-1304-85. 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 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 oral liquid containing docusate sodium, a stool softener commonly used to help ease bowel movements. Docusate sodium is an over-the-counter monograph product, meaning it is marketed under FDA's established guidelines for this category of medicine. The liquid form provides 50 milligrams of docusate sodium per 5 milliliters and is typically used as a laxative aid for people who want to soften stool.

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 $0.020 $9.51 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0398 $18.83 / 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
Dec 2021 Jul 2022 Jan 2026 Sep 2026 $0.022 $0.012
▲ Up 36% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00536-1304-85 You're viewing this Main listing 473 mL in 1 BOTTLE 2020-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Docusate Sodium Liquid 50 mg/5mLthis 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 —
Docusate Sodium 50 mg/5mL 00121-0935-16 PAI 473 ml $0.021 — Discontinued +6%
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

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 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.

💡 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, purified water, 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.

Manufacturer & labeler

LabelerRUGBY LABORATORIES
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedOct 2020
Product typeHuman Otc Drug
Portfolio149 products on file

More NDCs from RUGBY LABORATORIES labeler code 00536

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Uses Relief of occasional constipation

⏱️ Dosage and Administration 103 words ▾

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 86 words ▾

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 9 words ▾

Active Ingredients (per 5 mL) Docusate Sodium 50 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucralose

🎯 Purpose 3 words ▾

Purpose Stool Softener

🤰 If Pregnant or Breast-Feeding 9 words ▾

If pregnant or breast-feeding, ask a doctor before use

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-645-2158

📄 Package Label / Principal Display Panel 1 words ▾

RugbyDocu1304

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

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 this package alone, 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
31.9K
Units reimbursed last 4 qtrs
12.1M
Gross reimbursed last 4 qtrs
$481.6K
Avg / prescription
$15.09
Avg / unit
$0.0398
Latest quarter Q1 2026
6.2KRx
Medicaid pays / mL
$0.0398
gross reimbursed
vs
NADAC / mL
$0.0201
acquisition cost
=
Spread
+$0.0197
+98% 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 ⓘ
66% FFS 34% MCO
Fee-for-service · 21,005 Rx Managed care · 10,913 Rx
State Medicaid map
Alaska: no data reported AK Maine: 105,712 units · 7,578 per 100k residents ME Washington: 311,763 units · 3,991 per 100k residents WA Idaho: no data reported ID Montana: 5,037 units · 445 per 100k residents MT North Dakota: no data reported ND Minnesota: 533,461 units · 9,299 per 100k residents MN Wisconsin: 26,104 units · 442 per 100k residents WI Michigan: 520,386 units · 5,185 per 100k residents MI New York: 926,045 units · 4,732 per 100k residents NY Vermont: 28,994 units · 4,481 per 100k residents VT New Hampshire: 21,202 units · 1,512 per 100k residents NH Oregon: 177,862 units · 4,202 per 100k residents OR Nevada: 48,365 units · 1,514 per 100k residents NV Wyoming: 4,752 units · 814 per 100k residents WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 389,919 units · 3,107 per 100k residents IL Indiana: 797,830 units · 11,627 per 100k residents IN Ohio: 663,406 units · 5,629 per 100k residents OH Pennsylvania: 996,167 units · 7,686 per 100k residents PA New Jersey: 443,460 units · 4,774 per 100k residents NJ Massachusetts: 638,872 units · 9,125 per 100k residents MA California: 2,867,767 units · 7,360 per 100k residents CA Utah: no data reported UT Colorado: 73,334 units · 1,248 per 100k residents CO Nebraska: 263,092 units · 13,301 per 100k residents NE Missouri: 476,965 units · 7,698 per 100k residents MO Kentucky: 545,733 units · 12,058 per 100k residents KY West Virginia: no data reported WV Virginia: 186,988 units · 2,145 per 100k residents VA Maryland: 56,795 units · 919 per 100k residents MD Connecticut: 55,702 units · 1,540 per 100k residents CT Rhode Island: 94,309 units · 8,613 per 100k residents RI Arizona: 112,977 units · 1,520 per 100k residents AZ New Mexico: 13,330 units · 631 per 100k residents NM Kansas: 372,017 units · 12,654 per 100k residents KS Arkansas: no data reported AR Tennessee: 103,909 units · 1,458 per 100k residents TN North Carolina: no data reported NC South Carolina: 64,807 units · 1,206 per 100k residents SC Delaware: 61,628 units · 5,977 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 26,201 units · 891 per 100k residents MS Alabama: no data reported AL Georgia: 36,247 units · 329 per 100k residents GA D.C.: 39,466 units · 5,812 per 100k residents DC Hawaii: 21,415 units · 1,492 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
32913,301
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
🏆 Top states by units · per 100k residents
1 Nebraska 13,301 /100k
2 Kansas 12,654 /100k
3 Kentucky 12,058 /100k
4 Indiana 11,627 /100k
5 Minnesota 9,299 /100k
6 Massachusetts 9,125 /100k
7 Rhode Island 8,613 /100k
8 Missouri 7,698 /100k
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

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

20,329 reports
Male · 43%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization9,623
Death2,787
Life-threatening1,214
Disabling800
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,736 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.
← 00536-1303-75 · RUGBY 00536-1306-08 · Rugby →
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.