Prescription medicine
Atropine and diphenoxylate Brand names: Lomotil
Atropine and diphenoxylate (Lomotil) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.139 per diphenoxylate-atropine 2.5-0.025 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule V
Check it at the source: the atropine and diphenoxylate FDA label on DailyMed (effective February 23, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 12462 record on Drugs@FDA; every atropine and diphenoxylate label on DailyMed.
Highlights of the record
FDA label of February 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Forms and strengths
- 2.5 mg / 0.025 mg
- 2.5 mg/5ml / 0.025 mg/5ml
Tablet; solution.
On the market
- Earliest approval on file
- September 15, 1960 Lomotil, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 30 first April 18, 1977; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 19 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.139 per tablet Diphenoxylate-atropine 2.5-0.025 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 1 Class I among all firms' recalls; latest October 20, 2017
- FAERS reports
- 13,618 through July 30, 2026
What is atropine and diphenoxylate used for?
From the label: indications and usageLomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Conditions named in the indications of atropine and diphenoxylate's FDA labels, with every medicine labeled for each:
From other atropine and diphenoxylate labelsDiarrhea: INDICATIONS AND USAGE Lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
FDA pharmacologic class: Anticholinergic, Antidiarrheal and Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Lomotil), Pfizer Laboratories Div Pfizer Inc, effective February 23, 2026 (SPL set f170584a-1072-4fd7-b1dc-6756703483b9), via openFDA; the full label on DailyMed
Is there a generic for atropine and diphenoxylate (Lomotil)?
The FDA approved the first generic atropine and diphenoxylate on April 18, 1977. 30 generic applications are approved; 8 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 atropine and diphenoxylate from 19 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1960 earliest approval on file
- 1977 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 atropine and diphenoxylate (Lomotil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.139 per Diphenoxylate-atropine 2.5-0.025 mg tablet, down 21% from $0.176 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.
- Diphenoxylate-atropine 2.5-0.025 mg tablet (generic)
- Lomotil 2.5-0.025 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Diphenoxylate-atropine 2.5-0.025 mg tablet | Generic | $0.139 per tablet | $4.17 | -21% |
| Lomotil 2.5-0.025 mg tablet | Brand | $2.99 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $89.73 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has atropine and diphenoxylate been recalled?
The FDA's Enforcement Report lists 2 recalls naming atropine and diphenoxylate since 2013: 1 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 20, 2017 | Class I | Pfizer Inc. | SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the atropine and diphenoxylate label say about other medicines?
The atropine and diphenoxylate label names 2 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 |
|---|---|---|
| Buspirone | drug interactions | Other Drugs that Cause CNS Depression The concurrent use of Lomotil with other drugs that cause CNS depression (e.g., barbiturates, benzodiazepines, opioids, buspirone, antihistamines, muscle relaxants), may potentiate the effects of Lomotil (see WARNINGS ). |
| Meperidine | warnings | Interaction with Meperidine Hydrocholoride Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of Lomotil with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis. |
Source: FDA drug label (Lomotil), Pfizer Laboratories Div Pfizer Inc, effective February 23, 2026 (SPL set f170584a-1072-4fd7-b1dc-6756703483b9), via openFDA; the full label on DailyMed
What do FAERS reports show for atropine and diphenoxylate?
The FDA Adverse Event Reporting System holds 13,618 reports that list atropine and diphenoxylate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,339 are coded as a death and 5,218 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 atropine and diphenoxylate?
9 other medicines are given the same way (oral) and in the same FDA class as atropine and diphenoxylate 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 diphenoxylate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to atropine and diphenoxylate
- 9 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Atropine and diphenoxylate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other