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DOCUSATE SODIUM 50 mg/5mL Liquid, 10 mL — NDC 48433-220-10 (Billing 48433-0220-10)

by Safecor Health, LLC · 10 mL in 1 CUP, UNIT-DOSE

This is a package of 10 mL of DOCUSATE SODIUM 50 mg/5mL Liquid from Safecor Health, LLC, marketed since Sep 2021 and currently FDA-listed. It is this product's only package size.

NDC 48433-0220-10
🏷️ FDA NDC (as labeled) 48433-220-10 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) 48433-220-10
Product NDC 48433-220
11-digit billing NDC 48433022010
NCPDP billing unit ML — per mL (volume)
RxCUI 1248119
UNII F05Q2T2JA0
UPC 0348433220405
Application # M334
SPL Set ID efe4bf81-fb99-4755-aa23-4f8df5973be8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-01
Route ORAL
Dosage form LIQUID
Substance DOCUSATE SODIUM

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

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
Quick answers
  • GSN (GCN sequence number): 003017
  • GCN: 09131
  • HICL (First Databank): 001326
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 1248119
Why two NDCs? The FDA registers this code as 48433-220-10 — 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 → 48433-0220-10. 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 SOD 100 MG/10 ML CUP Ingredient Docusate Sodium
🧪 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 help soften stool and make bowel movements easier for people experiencing constipation or difficulty passing hard stools. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for stool softeners rather than being individually reviewed as a new drug application.

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
48433-0220-10 You're viewing this Main listing 10 mL in 1 CUP, UNIT-DOSE 2021-09-01 — 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 —
Docusate Sodium 50 mg/5mL 00121-0935-16 PAI 473 ml $0.021 — Discontinued —
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/5mLthis 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
Sep 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.

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

LabelerSafecor Health, LLC
FDA applicationM334 (OTC MONOGRAPH DRUG)
Labeler code48433
First marketedSep 2021
Product typeHuman Otc Drug
Portfolio55 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.

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 📄 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Use: Relief of occasional constipation

⏱️ Dosage and Administration ~1 min read ▾

Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * Shake well before using * Do not exceed recommended dose * May be taken in one to four equally divided oral doses each day * Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response Adults and children 12 years of age and over 5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor Children 6 to 12 years of age 4 mL to 15 mL (3 teaspoons) or as directed by a doctor Children 3 to 6 years of age 2 mL to 6 mL or as directed by a doctor Children under 3 years of age 1 mL to 4 mL or as directed by a doctor 1 teaspoon = 5 mL Other information: Each teaspoon (5 mL) contains: sodium 5 mg.

Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light.

For more info call 1-800-447-1006. Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucralose. NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473 3 4843322010 8

⚠️ Warnings 140 words ▾

WARNINGS: Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation If pregnant or breast feeding , ask a health care professional before use.

Keep this and all drugs out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

🧪 Active Ingredient 13 words ▾

Active Ingredient (in each 5 mL = 1 teaspoonful) Docusate Sodium 50 mg

🧪 Inactive Ingredients 54 words ▾

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucralose. NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473 3 4843322010 8

🎯 Purpose 3 words ▾

Purpose Stool Softener

📄 Do Not Use 25 words ▾

Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor

📄 Ask a Doctor Before Use If 29 words ▾

Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil

📄 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 within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation

🤰 If Pregnant or Breast-Feeding 13 words ▾

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

📄 Keep Out of Reach of Children 33 words ▾

Keep this and all drugs out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

📄 Other Information 34 words ▾

Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.

📄 Package Label / Principal Display Panel 138 words ▾

Principal Display Panel - Box Label SAFECOR HEALTH Docusate Sodium Liquid 100 mg / 10 ml Contains 40 (10 ml) Unit Dose Cups See monograph for complete drug information. NDC: 48433-220-40 QTY: 40 Lot: 21A0079 Exp: 2023-03-31 Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat.

Protect from light. This package design is not child resistant. For institutional use only.

Shake well before use. 3 48433 22040 5 Pkg By: Safecor Health, LLC Columbus, OH 43204 Questions or Comments: Call 1-800-447-1006 GTIN: 00348433220405 SN: 212802331 Exp; 2023-03-31 Lot 21A0079 PN5689.C Principal Display Panel - Box Label

Principal Display Panel - Lid Label Delivers 1 0 mL NDC 48433-220-10 Docusate Sodium Liquid 100 mg/10mL SHAKE WELL 348433220108 Pkg By: Safecor Health, LLC Columbus, OH 43204 PN5618.B Principal Display Panel - Lid 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 Safecor Health, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Safecor Health, LLC 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.
← 48433-0219-40 · Safecor 48433-0226-40 · Safecor →
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.