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(from DailyMed)

DOCUSATE SODIUM 100 mg Capsule, Liquid Filled, 30-count

by NuCare Pharmaceuticals,Inc. · 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68071-3438-3)
NDC 68071-3438-03
🏷️ FDA NDC (as labeled) 68071-3438-3 billing pads the package segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also comes in: 60 capsules 68071-3438-06
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 68071-3438-3
Product NDC 68071-3438
11-digit billing NDC 68071343803
RxCUI 1115005
UNII F05Q2T2JA0
UPC 0368071343861
Application # M007
SPL Set ID fdf3c8e1-d554-4cdb-e053-6394a90a542e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-15
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DOCUSATE SODIUM
Why two NDCs? The FDA registers this code as 68071-3438-3 — 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 → 68071-3438-03. 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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code68071
First marketedNov 2022
Product typeHuman Otc Drug
Portfolio1,015 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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter oral capsule containing docusate sodium, a stool softener. Docusate sodium is typically used to help soften stool and make bowel movements easier. It works by allowing water and fats to mix into the stool, which can be helpful for people who want to avoid straining during bowel movements. This product is marketed under FDA's over-the-counter monograph rules for laxatives and stool softeners.

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.

🧪 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.

💲 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: 60 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense stool softener 100 mg 00113-0486-72 L. 60 capsules $0.022 — Discontinued —
Quality Choice Stool Softener 100 mg 63868-0585-01 Chain 100 capsules $0.022 — FDA listed —
Stool Softener Laxative 100 mg 62011-0421-01 Strategic 100 capsules $0.024 — Discontinued —
Stool Softener Laxative 100 mg 70677-0034-01 Strategic 100 capsules $0.024 — Discontinued —
Docusate Sodium - Stool Softener Laxative 100 mg 00904-7183-61 Major 10 capsules $0.028 — Availability likely —
Stool Softener Laxative 100 mg 00904-7280-60 Major 100 capsules $0.028 — Availability likely —
Docusate sodium 100 mg 24689-0130-01 APNAR 100 capsules $0.028 — Availability likely —
Docusate Sodium 100 mg 45802-0486-78 Padagis 100 capsules $0.028 — Availability likely —
Good Neighbor Stool Softener 100 mg 46122-0692-72 AmerisourceBergen 60 capsules $0.028 — Availability likely —
Docusate Sodium 100 mg 60687-0129-01 American 1 capsule $0.028 — Availability likely —
Stool Softener Laxative 100 mg 70000-0091-01 CARDINAL 100 capsules $0.028 — Availability likely —
Stool Softener Laxative 100 mg 70677-1095-01 Strategic 100 capsules $0.028 — Availability likely —
Colace 100 mg 67618-0101-01 Atlantis 100 capsules $0.306 — Availability likely —
Fleet 100 mg 00132-0402-25 C.B. 25 capsules — — FDA listed —
Phillips Stool Softener Bulk Docusate 100 mg 00280-1012-30 Bayer 30 capsules — — FDA listed —
Gentle Stool Softener 100 mg 00363-1172-25 WALGREEN 25 capsules — — FDA listed —
Gentle Stool Softener 100 mg 00363-1179-25 WALGREEN 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-4100-20 Walgreens 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-4202-30 Walgreens 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-7111-10 Walgreens 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-8530-20 Walgreens 200 capsules — — FDA listed —
Stool Softener 100 mg 00363-8540-30 Walgreens 30 capsules — — FDA listed —
Docusate Sodium 100 mg 00363-8991-25 WALGREEN 25 capsules — — FDA listed —
Stool Softener 100 mg 00363-9944-20 Walgreen 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00615-8557-39 NCS 30 capsules — — FDA listed —
Docusate Sodium 100 mg 00904-7609-61 Major 1 capsule — — FDA listed —
Preferred Stool Softener 100 mg 10956-0621-00 Reese 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0341-16 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0512-66 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0678-16 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0853-16 TARGET 160 capsules — — FDA listed —
Docusate Sodium 100 mg 16103-0399-08 Pharbest 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 21130-0041-20 Safeway, 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 21130-0853-20 Safeway, 200 capsules — — FDA listed —
Stool Softener 100 mg 30142-0407-01 KROGER 100 capsules — — Discontinued —
Stool Softener Laxative 100 mg 30142-0451-25 The 250 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0553-25 The 250 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0778-10 The 100 capsules — — Discontinued —
Stool Softener Laxative 100 mg 36800-0638-10 TOP 100 capsules — — FDA listed —
Stool Softener 100 mg 36800-0651-25 TOP 25 capsules — — FDA listed —
Stool Softener 100 mg 37808-0580-01 HEB 100 capsules — — FDA listed —
Stool Softener 100 mg 37808-0582-01 HEB 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 37808-0853-30 H 300 capsules — — FDA listed —
Stool Softener Laxative 100 mg 37808-0862-10 H 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0107-25 United 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0241-10 United 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0853-10 United 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0862-25 United 25 capsules — — FDA listed —
Dulcolax Stool Softener 100 mg 41167-0221-02 Chattem, 25 capsules — — FDA listed —
Dulcolax Pink Stool Softener 100 mg 41167-0281-01 Chattem, 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 49035-0385-50 EQUATE 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 49035-0526-14 EQUATE 140 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-5524-01 A-S 100 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-6140-01 A-S 100 capsules — — FDA listed —
Stool Softener 100 mg 50090-7167-01 A-S 100 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-7479-01 A-S 100 capsules — — FDA listed —
Stool Softener 100 mg 50804-0424-25 Good 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 50804-0701-25 Good 25 capsules — — FDA listed —
Stool Softener 100 mg 51013-0819-01 PuraCap 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 51316-0107-10 CVS 100 capsules — — FDA listed —
Docusate Sodium 100 mg 53345-0008-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53345-0018-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53345-0023-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg 100 mg 53345-0029-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53943-0250-10 Discount 100 capsules — — FDA listed —
Stool Softener Docusate Sodium 100 mg 54257-0902-02 Magno-Humphries, 100 capsules — — FDA listed —
Docusate Sodium - Stool Softener Laxative 100 mg 55154-3369-00 Cardinal 1 capsule — — FDA listed —
Docusate Sodium 100 mg 55289-0493-12 PD-Rx 12 capsules — — FDA listed —
exchange select stool softener 100 mg 55301-0486-78 Army 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55319-0561-10 Family 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0048-10 Dolgencorp, 100 capsules — — FDA listed —
Stool Softener 100 mg 55910-0762-50 Dolgencorp, 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0853-10 Dolgencorp, 100 capsules — — FDA listed —
Stool Softener 100 mg 55910-0938-25 Dolgencorp, 25 capsules — — FDA listed —
Stool Softener 100 mg 55910-0939-20 Dolgencorp, 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0968-40 Dolgencorp, 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 56062-0241-10 Publix 100 capsules — — FDA listed —
Stool Softener 100 mg 57896-0401-01 Geri-Care 100 capsules — — FDA listed —
Stool Softener 100 mg 57896-0411-01 Geri-Care 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0141-01 P 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0142-01 P 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0852-01 P 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0853-01 P 1000 capsules — — FDA listed —
Docusate Sodium 100 mg 63187-0476-00 Proficient 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63868-0638-25 QUALITY 250 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63941-0853-10 Best 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63981-0853-40 Costco 400 capsules — — FDA listed —
Docusate Sodium 100 mg 66267-0888-30 NuCare 30 capsules — — FDA listed —
Winco Stool Softener 100 mg 67091-0366-10 WinCo 100 capsules — — FDA listed —
Winco Stool Softener 100 mg 67091-0380-25 WinCo 25 capsules — — FDA listed —
Docusate Sodium 100 mg 68071-2874-00 NuCare 100 capsules — — FDA listed —
Docusate Sodium 100 mgthis 68071-3438-03 NuCare 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68071-3784-00 NuCare 100 capsules — — FDA listed —
Stool Softener 100 mg 68196-0853-60 Sam's 600 capsules — — FDA listed —
Docusate Sodium 100 mg 68196-0995-64 Sam's 600 capsules — — FDA listed —
Stool Softener Regular Strength 100 mg 68196-0998-60 Sam's 600 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68391-0041-40 BJWC 400 capsules — — FDA listed —
Stool Softener 100 mg 68391-0730-40 BJWC 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68391-0853-40 BJWC 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68788-8501-01 Preferred 100 capsules — — FDA listed —
Docusate Sodium 100 mg 68788-8658-03 Preferred 30 capsules — — FDA listed —
Stool Softener 100 mg 68788-8919-01 Preferred 100 capsules — — FDA listed —
Stool Softener 100 mg 68998-0420-01 Marc 100 capsules — — FDA listed —
Stool Softener 100 mg 69168-0420-01 Allegiant 100 capsules — — FDA listed —
Stool Softener 100 mg 69168-0424-32 Allegiant 100 capsules — — FDA listed —
Stool Softener 100 mg 69618-0086-01 Reliable 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0317-30 CVS 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0579-30 CVS 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0782-10 CVS 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0794-10 CVS 100 capsules — — FDA listed —
Stool Softener 100 mg 69842-0861-10 CVS 100 capsules — — FDA listed —
Stool Softener 100 mg 69842-0862-10 CVS 100 capsules — — Discontinued —
Stool Softener Laxative 100 mg 69842-0893-30 CVS 30 capsules — — FDA listed —
Stool Softener 100 mg 71335-0294-00 Bryant 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 71335-9731-00 Bryant 18 capsules — — FDA listed —
Stool Softener 100 mg 72162-2255-01 Bryant 100 capsules — — FDA listed —
basic care stool softener 100 mg 72288-0486-78 Amazon.com 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0041-10 Care 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0107-25 Care 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0853-10 Care 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0862-25 Care 25 capsules — — FDA listed —
Docusate Sodium 100 mg 72789-0399-30 PD-Rx 30 capsules — — FDA listed —
Topcare Stool Softener 100 mg 76162-0006-01 TopCo 100 capsules — — FDA listed —
Topcare Stool Softener 100 mg 76162-0761-25 TOPCO 25 capsules — — FDA listed —
Topcare Stool Softener 100 mg 76162-0777-99 TOPCO 250 capsules — — FDA listed —
Docusate Sodium 100 mg 76420-0225-30 Asclemed 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 79481-0853-01 Meijer 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 79903-0170-50 WALMART 50 capsules — — FDA listed —
Docusate Sodium 100 mg 81877-0840-90 Forreal 90 capsules — — FDA listed —
FEVIA Constipation Control 100 mg 82706-0029-01 VIVUNT 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 82804-0097-00 Proficient 100 capsules — — FDA listed —
Quality Choice Stool Softener 100 mg 83324-0197-01 Chain 100 capsules — — FDA listed —
Stool Softener 100 mg 85111-0401-10 RMT 1000 capsules — — FDA listed —
Docusate Sodium 100Mg 100 mg 85786-0502-24 Farmacias 24 capsules — — FDA listed —
HEB Stool Softener 100 mg 37808-0222-52 H 100 capsules — — FDA listed —
HEB Stool Softener 100 mg 37808-0457-52 H 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0280-10 The 100 capsules — — FDA listed —
stool softener 100 mg 72288-0035-78 Amazon.com 100 capsules — — FDA listed —
Docusate Sodium 100 mg 55154-0578-00 Cardinal 1 capsule — — FDA listed —
MiraSOFT Stool Softener 100 mg 11523-8259-03 Bayer 30 capsules — — FDA listed —
HyVee Regular Strength Stool Softener SOFTGEL 100 mg 42507-0108-01 HyVee 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.

⏳ Availability & generic status

🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 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.

🔬 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 — the ingredient across all brands.

Top reported reactions

Fatigue5,207
Nausea4,922
Dyspnoea3,838
Diarrhoea3,794
Constipation3,746
Death3,437
Pain3,409

Age at onset

Neonate16
Infant27
Child48
Adolescent69
Adult3,782
Elderly4,474

Reporter sex

61,443 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization26,727
Life-threatening2,578
Disabling1,814
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 4,713 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68071-3438-06 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68071-3438-6) 2023-06-12 Active
68071-3438-03 You're viewing this 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68071-3438-3) 2023-06-12 Active

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

Pack size FAQ

What quantity is in NDC 68071-3438-03?
NDC 68071-3438-03 is a 30-count package — 30 capsule, liquid filled in 1 bottle, plastic.
What is the difference between NDC 68071-3438-03 and NDC 68071-3438-06?
Both are DOCUSATE SODIUM 100 mg Capsule, Liquid Filled — the drug itself is identical. NDC 68071-3438-03 is the 30-count package, while NDC 68071-3438-06 is the 60 capsules package.
What NDC number is used to bill for this package of DOCUSATE SODIUM 100 mg Capsule, Liquid Filled?
Bill NDC 68071-3438-03 — the 11-digit billing format is 68071343803. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 68071-3438-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68071-3438-03, written without dashes as 68071343803. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68071-3438-03, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (3438) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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 NuCare Pharmaceuticals,Inc.. Listing status can change — 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 60 capsules (68071-3438-06). 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?
NuCare Pharmaceuticals,Inc. 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.

📄 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 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

⏱️ Dosage and Administration 48 words ▾

Directions take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

⚠️ Warnings 117 words ▾

Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative. These could be a sign of a serious condition. you need to use a stool softener laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.

📦 How Supplied / Storage and Handling 77 words ▾

HOW SUPPLIED: Compare to the active ingredient in Colace® Regular Strength Stool Softener† DOCUSATE SODIUM, 100 mg NDC 68071-3438-3 BOTTLES OF 30 NDC 68071-3438-6 BOTTLES OF 60 STOOL SOFTENER LAXATIVE Gentle, Dependable Stimulant-free SOFTGELS †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com

📦 Storage and Handling 17 words ▾

Other information each softgel contains: sodium 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each softgel) Docusate Sodium 100 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitol special, white edible ink

🎯 Purpose 4 words ▾

Purpose Stool softener laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68071-3437-05 · NuCare 68071-3440-09 · NuCare →
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.