Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Prolaxa Docusate Sodium 250mg 250 mg Capsule, Liquid Filled, 100-count — NDC 53225-2001-1 (Billing 53225-2001-01)
by Terrain Pharmaceuticals · 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
This is a package of 100 capsules of Prolaxa Docusate Sodium 250mg 250 mg Capsule, Liquid Filled from Terrain Pharmaceuticals, marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.
NDC 53225-2001-01
🏷️ FDA NDC (as labeled)
53225-2001-1
billing pads the package segment with a zero
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
53225-2001-1
Product NDC
53225-2001
11-digit billing NDC
53225200101
NCPDP billing unit
EA — each (per item)
UNII
F05Q2T2JA0
Application #
M007
SPL Set ID
32610e42-f352-09fd-e063-6394a90abff6
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-04-15
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
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
PROLAXA 250 MG SOFTGEL
FDB brand name
Prolaxa
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 53225-2001-1 — a 5-4-1 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 package segment → 53225-2001-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name PROLAXA 250 MG SOFTGEL 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?
Prolaxa Docusate Sodium is an over-the-counter oral capsule containing docusate sodium, a stool softener. Docusate sodium is commonly used to help soften stool and ease bowel movements. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for this category rather than undergoing individual drug approval.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Docusate Sodium 250mg?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 | 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 53225-2001-01 You're viewing this Main listing | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2025-04-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 | — | — | FDA listed | — |
| Prolaxa 250 mgthis 53225-2001-01 | Terrain | 100 capsules | — | — | FDA listed | — |
| Docusate Sodium 250 mg 53345-0035-01 | Humanwell | 7000 capsules | — | — | FDA listed | — |
| Docusate Sodium 250 mg 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 | — |
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Apr 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.
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Color
yellow
ShapeCapsule
ImprintC76
Size9 mm
ScoringNot scored
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.
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
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 6O92ICV9RU
A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesGELATIN, GLYCERIN, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, SORBITAN
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerTerrain Pharmaceuticals
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code53225
First marketedApr 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📋 Description
🎯 Indications and Usage ▾
Uses for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours
⏱️ Dosage and Administration ▾
Directions adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor
⚠️ Warnings ▾
Warnings Do not use if you are presently 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 last over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
🧪 Active Ingredient ▾
Active ingredient (in each softgel) Docusate sodium 250 mg - Extra Strength
🧪 Inactive Ingredients ▾
Inactive Ingredients GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, SORBITAN
🎯 Purpose ▾
Purpose Stool softener laxative
📋 Description ▾
Prolaxa™ PROLAXA™ Stool Softener DOCUSATE SODIUM, 250 mg STOOL SOFTENER LAXATIVE - SOFTGELS MAXIMUM STRENGTH Easy to swallow Relieves constipation Gentle Relieve Dependable Stimulant Free TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
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 ↗
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 | ✓ Available |
| Inactive ingredients (structured) | ✓ 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 Terrain Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Terrain Pharmaceuticals 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.
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.