Over-the-counter medicine
Docusate
Docusate is an over-the-counter medicine. No generic is listed; pharmacies paid $0.0276 per unit (Docusate sodium 100 mg softgel) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the docusate FDA label on DailyMed (effective February 6, 2025); every docusate label on DailyMed.
Highlights of the record
FDA label of February 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagerelieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Forms and strengths
- 50 mg
- 100 mg
- 240 mg
- 250 mg
- 50 mg/5ml
- 50 mg/15ml
- 100 mg/10ml
- 100 mg/5ml
- 283 mg/5ml
Liquid-filled capsule; liquid; capsule; tablet; gelatin-coated capsule.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 97 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0276 per unit Docusate sodium 100 mg softgel
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 1 Class I among all firms' recalls; latest November 11, 2024; 7 more by firms not listed as its makers
- FAERS reports
- 58,569 through July 30, 2026
What is docusate used for?
From the label: indications and usagerelieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Conditions named in the indications of docusate's FDA labels, with every medicine labeled for each:
From other docusate labelsConstipation: Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Source: FDA drug label (Docusate Sodium), PAI Holdings, LLC dba PAI Pharma, effective February 6, 2025 (SPL set e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5), via openFDA; the full label on DailyMed
Is there a generic for docusate?
No generic docusate is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for docusate?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0276 per unit (Docusate sodium 100 mg softgel), down 5% from $0.029 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Docusate sodium 100 mg softgel (generic)
- Colace 100 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Docusate sodium 100 mg softgel | Generic | $0.0276 per unit | n/a | -5% |
| Docusate sodium 250 mg softgel | Generic | $0.0523 per unit | n/a | -0.6% |
| Docusate sodium 50 mg/5 mL liquid | Generic | $0.0201 per mL | n/a | -7% |
| Docusate sodium mini enema | Generic | $0.461 per mL | n/a | -5% |
| Dok 100 mg tablet | Generic | $0.039 per tablet | $1.17 | -0.1% |
| Ft stool softener 100 mg sftgl | Generic | $0.0276 per unit | n/a | -5% |
| Ft stool softener 100 mg tablet | Generic | $0.039 per tablet | $1.17 | -0.1% |
| Ft stool softener 250 mg sftgl | Generic | $0.0523 per unit | n/a | -0.6% |
| Gnp stool softener 100 mg sfgl | Generic | $0.0276 per unit | n/a | -5% |
| Gnp stool softener 250 mg sfgl | Generic | $0.0523 per unit | n/a | -0.6% |
| Stool softener 100 mg softgel | Generic | $0.0276 per unit | n/a | -5% |
| Colace 100 mg capsule | Brand | $0.306 per capsule | $9.17 | +0.4% |
| Colace clear 50 mg softgel | Brand | $0.256 per unit | n/a | +1% |
| Enemeez mini enema | Brand | $0.387 per mL | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has docusate been recalled?
The FDA's Enforcement Report lists 9 recalls naming docusate since 2013: 1 Class I (the most serious), 8 Class II, 0 Class III; 1 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of docusate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 11, 2024 | Class II | Safecor Health, LLC | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. |
| January 16, 2019 | Class II | Rx Pak Division of McKesson Corporation | Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps. |
| July 25, 2016 | Class I | US Compounding Inc not a listed maker | Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD37063_4 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl, Tablet, 25 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PIOGLITAZONE, Tablet, 15 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for docusate?
The FDA Adverse Event Reporting System holds 58,569 reports that list docusate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,622 are coded as a death and 25,409 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as docusate?
15 other medicines are given the same way (oral) and in the same FDA class as docusate or labeled mainly for the same use (constipation), the same class first. Constipation lists all 20 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sennosides | Constipation | none listed | $0.0258 per tablet 8.6 mg tablet | No current entry |
| Polyethylene glycol 3350 | Constipation | 73 labelers | $0.0286 per gram 3350 powd | No current entry |
| Bisacodyl | Constipation | none listed | $0.0441 per tablet 5 mg tablet | No current entry |
| Magnesium hydroxide | Constipation | none listed | $0.0095 per mL Milk of magnesia suspension | No current entry |
| Magnesium citrate | Constipation | none listed | $0.0066 per mL Magnesium citrate solution | No current entry |
| Lubiprostone | Constipation | 10 labelers | $0.651 per capsule 24 mcg capsule | No current entry |
| Prucalopride | Constipation | 18 labelers | $0.639 per tablet 1 mg tablet | No current entry |
| Psyllium husk | Constipation | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does docusate compare with medicines for the same use?
3 side-by-side pages set docusate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to docusate
- 15 medicines for the same use
- Docusate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other