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Docusate Sodium 100 mg/10mL Liquid, 200000 mL — NDC 84447-011-01 (Billing 84447-0011-01)

by Belleview Bio Science · 200000 mL in 1 DRUM

This is a package of 200,000 mL of Docusate Sodium 100 mg/10mL Liquid from Belleview Bio Science, marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 84447-0011-01
🏷️ FDA NDC (as labeled) 84447-011-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84447-011-01
Product NDC 84447-011
11-digit billing NDC 84447001101
RxCUI 1248119
UNII F05Q2T2JA0
Application # M007
SPL Set ID 335f41d7-5c22-7c17-e063-6294a90a8f28
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-01
Route ORAL
Dosage form LIQUID
Substance DOCUSATE SODIUM
Quick answers
  • RxCUI (RxNorm): 1248119
Why two NDCs? The FDA registers this code as 84447-011-01 — 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 → 84447-0011-01. 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

🧪 What is this product?

Docusate Sodium 100 mg/10mL Liquid is an over-the-counter oral product marketed under FDA's OTC monograph rules for stool softeners. Docusate sodium is a surfactant compound that is commonly used to help soften stool and make bowel movements easier, typically in people experiencing occasional constipation. This liquid form allows for flexible dosing and is intended for oral administration.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84447-0011-01 You're viewing this Main listing 200000 mL in 1 DRUM 2025-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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/10mL 81033-0022-50 Kesin 100 cups — — FDA listed —
Docusate Sodium 100 mg/10mLthis 84447-0011-01 Belleview 200000 ml — — FDA listed —
Docusate Sodium 100 mg/10mL 00121-1870-00 PAI 10 cups — — FDA listed —
Docusate Sodium 100 mg/10mL 00904-7279-72 Major 10 cups — — FDA listed —
Docusate Sodium 100 mg/10mL 60687-0878-56 American 10 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

🏛️
2025
On the market since
Mar 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.

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.

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

LabelerBelleview Bio Science
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code84447
First marketedMar 2025
Product typeHuman Otc Drug
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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 123 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 persist 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 If pregnant or breast-feeding, ask a health professional before use.

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

🆘 Overdosage 15 words ▾

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

🧪 Active Ingredient 10 words ▾

Active Ingredient (in each 10 mL) 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

📄 Do Not Use 25 words ▾

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 27 words ▾

Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that persist over a period of 2 weeks

📄 Stop Use and Ask a Doctor If 39 words ▾

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

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children

📄 Other Information 49 words ▾

Other Information store at controlled room temperature 20ºC to 25ºC (68ºF to 77ºF) protect from light protect from excessive heat protect from freezing clear, grape-flavored liquid, supplied in the following: NDC 81033-022-10: 10 mL unit dose cup NDC 81033-022-50: Case containing 100 unit dose cups of 10 mL each

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-833-537-4679

📄 Package Label / Principal Display Panel 24 words ▾

BULK SHIPMENT: For institutional or repackaging use only. Docusate Sodium Liquid 50 mg per 5 mL 200,00 mL NDC: 8447-011-01 Docusate Sodium Bulk Label

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 — Not published for this NDC No photo available yet for this listing.
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 Belleview Bio Science. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Belleview Bio Science 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.
← 84447-0010-12 · Belleview 84447-0017-01 · Belleview →
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.