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Docusate Sodium 250 mg Capsule, Liquid Filled, 100-count — NDC 54629-601-01 (Billing 54629-0601-01)

by National Vitamin Company · 100 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 100 capsules of Docusate Sodium 250 mg Capsule, Liquid Filled from National Vitamin Company, marketed since May 2000 and currently FDA-listed, this package's marketing is listed to end Oct 2027. It is the main listing for this product, which comes in 2 package sizes.

NDC 54629-0601-01
🏷️ FDA NDC (as labeled) 54629-601-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Main listing for product 54629-601 · Also comes in: 1000 capsules 54629-601-99
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) 54629-601-01
Product NDC 54629-601
11-digit billing NDC 54629060101
NCPDP billing unit EA — each (per item)
RxCUI 1245468
UNII F05Q2T2JA0
Application # M007
SPL Set ID 0c66642c-82cb-42cd-82bb-5f95852cc5d1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-05-01
Marketing end 2027-10-31
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DOCUSATE SODIUM

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

GPI-14 46500010300120
GPI class Docusate Sodium
GCN Seq No 003011
GCN 09102
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 250 MG SOFTGEL
FDB brand name Docusate Sodium
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 003011
  • GCN: 09102
  • GPI-14 (Medi-Span): 46500010300120
  • HICL (First Databank): 001326
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 1245468
Why two NDCs? The FDA registers this code as 54629-601-01 — 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 → 54629-0601-01. 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

Label name DOCUSATE SODIUM 250 MG SOFTGEL Ingredient Docusate Sodium
🧪 What is this product?

This is an over-the-counter oral capsule containing docusate sodium, a stool softener marketed under FDA's OTC monograph rules for digestive health products. Docusate sodium is typically used to ease bowel movements by softening stool, making it commonly included in products intended to relieve occasional constipation. The liquid-filled capsule format allows for easy swallowing.

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.
Try another pack size: 1000 capsules
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
54629-0601-01 You're viewing this Main listing 100 CAPSULE, LIQUID FILLED in 1 BOTTLE 2000-05-01 Oct 31, 2027 Active
54629-0601-99 54629-601-99 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE 2000-05-01 Oct 31, 2027 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 54629-0601-99?
Both are Docusate Sodium 250 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 100-count one, while NDC 54629-0601-99 is the 1000 capsules package.
What NDC number is used to bill for this package of Docusate Sodium 250 mg Capsule, Liquid Filled?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stool Softener Laxative 250 mg 00904-7281-60 Major 100 capsules $0.052 — Availability likely —
Good Neighbor Stool Softener laxative 250 mg 46122-0693-78 AmerisourceBergen 100 capsules $0.052 — Availability likely —
Stool Softener 250 mg 46122-0826-74 Amerisource 100 capsules $0.052 — Availability likely —
Docusate Sodium 250 mg 50268-0268-15 AvPAK 1 capsule $0.052 — Availability likely —
Stool Softener 250 mg 70677-1096-01 Strategic 100 capsules $0.052 — Availability likely —
Preferred Stool Softener laxative 250 mg 10956-0781-00 Reese 140 capsules — — FDA listed —
Stool Softener Laxative 250 mg 17856-7281-01 ATLANTIC 1 capsule — — FDA listed —
Stool Softener Laxative Extra Strength 250 mg 36800-0568-10 TOP 100 capsules — — Discontinued —
Stool Softener 250 mg 36800-0640-10 TOP 100 capsules — — FDA listed —
H E B Stool Softener laxative 250 mg 37808-0293-88 H 140 capsules — — FDA listed —
Stool Softener 250 mg 37808-0585-14 HEB 140 capsules — — FDA listed —
Stool Softener 250 mg 37808-0879-14 H 140 capsules — — FDA listed —
Stool Softener 250 mg 37835-0223-01 Bi-Mart 100 capsules — — FDA listed —
Stool Softener Extra Strength 250 mg 41250-0859-10 MEIJER, 100 capsules — — FDA listed —
Stool Softener Extra Strength 250 mg 49035-0378-14 EQUATE 140 capsules — — Discontinued —
Prolaxa 250 mg 53225-2001-01 Terrain 100 capsules — — FDA listed —
Docusate Sodium 250 mg 53345-0035-01 Humanwell 7000 capsules — — FDA listed —
Docusate Sodium 250 mgthis 54629-0601-01 National 100 capsules — — FDA listed —
Docusate Sodium 250 mg 55154-4341-00 Cardinal 1 capsule — — Discontinued —
Stool Softener Extra Strength 250 mg 55910-0879-10 Dolgencorp, 100 capsules — — FDA listed —
Stool Softener 250 mg 57896-0426-01 Geri-Care 100 capsules — — FDA listed —
Stool Softener Extra Strength 250 mg 59726-0058-25 P 250 capsules — — FDA listed —
Stool Softener Laxative Extra Strength 250 mg 59726-0059-10 P 100 capsules — — FDA listed —
Stool Softener Laxative Extra Strength 250 mg 59726-0879-10 P 100 capsules — — FDA listed —
Quality Choice Stool Softener laxative 250 mg 63868-0662-01 Chain 100 capsules — — FDA listed —
Colace Extra Strength Stool Softner 250 mg 67618-0201-12 Atlantis 60 capsules — — FDA listed —
Stool Softener Laxative 250 mg 68016-0471-01 Chain 100 capsules — — FDA listed —
Stool Softener Extra Strength 250 mg 68016-0587-00 Chain 100 capsules — — FDA listed —
Stool Softener 250 mg 68071-5297-06 NuCare 60 capsules — — FDA listed —
Stool Softener Extra Strength 250 mg 69842-0740-25 CVS 250 capsules — — FDA listed —
Stool Softener Extra Strength 250 mg 69842-0879-25 CVS 250 capsules — — FDA listed —
Stool Softener 250 mg 71335-1677-01 Bryant 30 capsules — — FDA listed —
Docusate Sodium 250 mg 72789-0166-60 PD-Rx 60 capsules — — FDA listed —
Topcare Stool Softener laxative 250 mg 76162-0764-10 TOPCO 100 capsules — — FDA listed —
Stool Softener Laxative Extra Strength 250 mg 79903-0073-14 WALMART 140 capsules — — FDA listed —
Prolaxa 250 mg 80425-0540-01 Advanced 100 capsules — — FDA listed —
Docusate Sodium, Extra Strength 250 Mg 80513-0100-01 Advanced 100 capsules — — FDA listed —
Docusate Sodium, Extra Strength 250 Mg 80513-0101-01 Advanced 100 capsules — — FDA listed —
Stool Softener Laxative 250 mg 71335-2313-01 Bryant 30 capsules — — 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

🏛️
2000
On the market since
May 2000
📍
2026
Currently FDA-listed
26 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

LabelerNational Vitamin Company
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code54629
First marketedMay 2000
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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses • For the relief of occasional constipation. • Helps to prevent dry, hard stools. • This product generally produces a bowel movement within 12 to 72 hours.

⏱️ Dosage and Administration 54 words ▾

Directions Adults and Children over 12 years of age Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor.

⚠️ Warnings 111 words ▾

WARNINGS Do not use: • If you are currently taking mineral oil, unless directed by a doctor. • When abdominal pain, nausea, or vomiting are present. • For longer than one week unless directed by a doctor. Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use.

If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

Active Ingredient (in each softgel) Docusate Sodium 250 mg

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

🎯 Purpose 3 words ▾

Purpose Stool Softener

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks.

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Questions or Comments 5 words ▾

Questions Call 1 (800) 682-9862

📄 Package Label / Principal Display Panel 32 words ▾

Package/Label Principal Display Panel NDC 54629-601-01 Life-Line® Docusate Sodium, USP Stool Softener 250 mg Each 100 Softgels Manufactured and Distributed by National Vitamin Company Casa Grande, AZ 85122 Bottle Label Bottle 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 it is currently marketed — but National Vitamin Company has reported a marketing end date of 2027-10-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1000 capsules (54629-0601-99). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
National Vitamin Company 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.
← 54622-0712-01 · Georgia-Pacific 54633-0014-02 · The →
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.