Prescription medicine
Dicyclomine First approved as Bentyl
Dicyclomine (Bentyl) is a prescription medicine with an FDA approval on record since 1950. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.059 per dicyclomine 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dicyclomine FDA label on DailyMed (effective August 6, 2026, Lannett Company, LLC); the NDA 7409 record on Drugs@FDA; every dicyclomine label on DailyMed.
Highlights of the record
FDA label of August 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Forms and strengths
- 10 mg
- 20 mg
- 40 mg
- 10 mg/ml
- 10 mg/5ml
- 20 mg/2ml
Tablet; capsule; injection (solution); solution; injection.
On the market
- Earliest approval on file
- May 11, 1950 Bentyl, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 38 first September 30, 1974; 31 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 43 of which 43 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.059 per tablet Dicyclomine 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest July 23, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 14,164 through July 30, 2026
What is dicyclomine used for?
From the label: indications and usageDicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome
Conditions named in the indications of dicyclomine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anticholinergic.
Source: FDA drug label (Dicyclomine Hydrochloride), Lannett Company, LLC, effective August 6, 2026 (SPL set bd2cba10-70ec-4d1f-b46c-53d1de2ee130), via openFDA; the full label on DailyMed
Is there a generic for dicyclomine (Bentyl)?
The FDA approved the first generic dicyclomine on September 30, 1974. 38 generic applications are approved; 31 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dicyclomine from 43 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1950 earliest approval on file
- 1974 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dicyclomine (Bentyl)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.059 per Dicyclomine 20 mg tablet, down 12% from $0.0674 on October 8, 2025. 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.
- Dicyclomine 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dicyclomine 10 mg capsule | Generic | $0.0777 per capsule | $2.33 | -6% |
| Dicyclomine 10 mg/5 mL solution | Generic | $0.174 per mL | n/a | -6% |
| Dicyclomine 20 mg tablet | Generic | $0.059 per tablet | $1.77 | -12% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dicyclomine been recalled?
The FDA's Enforcement Report lists 4 recalls naming dicyclomine since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of dicyclomine and that holds 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 |
|---|---|---|---|
| July 23, 2026 | Class II | Aurobindo Pharma USA Inc | shortfill; reports of empty capsules. |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: DICYCLOMINE HCL, Tablet, 20 mg may have potentially been mislabeled as the following drug: RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dicyclomine label say about other medicines?
The dicyclomine label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amantadine | drug interactions | Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO … |
| Digoxin | drug interactions | Absorption of Other Drugs Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result. |
| Meperidine | drug interactions | … antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity. |
| Metoclopramide | drug interactions | Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. |
| Quinidine | drug interactions | Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO … |
Source: FDA drug label (Dicyclomine Hydrochloride), Lannett Company, LLC, effective August 6, 2026 (SPL set bd2cba10-70ec-4d1f-b46c-53d1de2ee130), via openFDA; the full label on DailyMed
What do FAERS reports show for dicyclomine?
The FDA Adverse Event Reporting System holds 14,164 reports that list dicyclomine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 848 are coded as a death and 4,288 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 dicyclomine?
4 other medicines are given the same way (oral) and in the same FDA class as dicyclomine or labeled mainly for the same use (irritable bowel syndrome), the same class first. Irritable bowel syndrome lists all 7 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Chlordiazepoxide and clidinium | Irritable bowel syndrome | 12 labelers | $0.256 per capsule Chlordiazepoxide-clidinium capsule | No current entry |
| Tenapanor | Irritable bowel syndrome | none listed | $32.54 per tablet 50 mg tablet | No current entry |
| Linaclotide | Irritable bowel syndrome | none listed | $9.02 per capsule 145 mcg capsule | No current entry |
| Eluxadoline | Irritable bowel syndrome | none listed | $28.09 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as dicyclomine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dicyclomine
- 4 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Dicyclomine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other