Prescription medicine
Atropine and difenoxin Brand names: Motofen; first approved as Motofen Half-Strength
Atropine and difenoxin (Motofen) is a prescription medicine with an FDA approval on record since 1978. No generic is listed; pharmacies paid $6.91 per Motofen 1-0.025 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- DEA Schedule IV
Check it at the source: the atropine and difenoxin FDA label on DailyMed (effective March 23, 2026, Legacy Pharma USA Inc.); the NDA 17744 record on Drugs@FDA; every atropine and difenoxin label on DailyMed.
Highlights of the record
FDA label of March 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMOTOFEN ® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Forms and strengths
- 1 mg / 0.025 mg
Tablet.
On the market
- Earliest approval on file
- July 14, 1978 Motofen Half-Strength, Legacy; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $6.91 per tablet Motofen 1-0.025 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 26 through July 30, 2026
What is atropine and difenoxin used for?
From the label: indications and usageMOTOFEN ® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Conditions named in the indications of atropine and difenoxin's FDA labels, with every medicine labeled for each:
From other atropine and difenoxin labelsDiarrhea: INDICATIONS AND USAGE MOTOFEN ® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
FDA pharmacologic class: Anticholinergic, Antidiarrheal and Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Motofen), Legacy Pharma USA Inc., effective March 23, 2026 (SPL set 1fa11c67-5492-469c-9475-6bfa0e5e9ff8), via openFDA; the full label on DailyMed
Is there a generic for atropine and difenoxin (Motofen)?
No generic atropine and difenoxin is approved (Drugs@FDA, October 8, 2026).
- 1978 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for atropine and difenoxin (Motofen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.91 per Motofen 1-0.025 mg tablet, about the same as a year earlier. 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.
- Motofen 1-0.025 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Motofen 1-0.025 mg tablet | Brand | $6.91 per tablet | $207.40 | -0.6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the atropine and difenoxin label say about other medicines?
The atropine and difenoxin label names 1 other medicine 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 |
|---|---|---|
| Meperidine | drug interactions | Drug Interactions Since the chemical structure of difenoxin hydrochloride is similar to meperidine hydrochloride, the concurrent use of MOTOFEN ® with monoamine oxidase inhibitors may, in theory, precipitate a hypertensive crisis. |
Source: FDA drug label (Motofen), Legacy Pharma USA Inc., effective March 23, 2026 (SPL set 1fa11c67-5492-469c-9475-6bfa0e5e9ff8), via openFDA; the full label on DailyMed
What do FAERS reports show for atropine and difenoxin?
The FDA Adverse Event Reporting System holds 26 reports that list atropine and difenoxin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 10 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.
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 atropine and difenoxin?
9 other medicines are given the same way (oral) and in the same FDA class as atropine and difenoxin or labeled mainly for the same use (diarrhea), the same class first. Diarrhea lists all 16 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 |
|---|---|---|---|---|
| Crofelemer | Diarrhea | none listed | n/a | No current entry |
| Bismuth subsalicylate | Diarrhea | none listed | $0.0817 per tablet 262 mg tablet chewable | No current entry |
| Loperamide | Diarrhea | 98 labelers | $0.0549 per capsule 2 mg capsule | No current entry |
| Ciprofloxacin | Diarrhea | 46 labelers | $0.123 per tablet 500 mg tablet | No current entry |
| Dimethicone and loperamide | Diarrhea | 33 labelers | $0.286 per unit Gs anti-diarrheal-antigas cplt | No current entry |
| Nitazoxanide | Diarrhea | 4 labelers | $82.20 per tablet 500 mg tablet | No current entry |
| Rifaximin | Diarrhea | none listed | n/a | No current entry |
| Octreotide | Diarrhea | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as atropine and difenoxin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to atropine and difenoxin
- 9 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Atropine and difenoxin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other