DEA schedule
Is diphenoxylate and atropine a controlled substance?
Federal schedule for diphenoxylate and atropine from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
Yes. Diphenoxylate and atropine is a Schedule V controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Diphenoxylate preparations 2.5 mg/25 ug AtSO4 (Schedule V).
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 28 prescription listings from 21 labelers, all Schedule V |
| DEA controlled substances list | Diphenoxylate: Schedule II; Diphenoxylate preparations 2.5 mg/25 ug AtSO4: Schedule V |
DEA list entry
| Substance | DEA code | Schedule | Narcotic | Other names | Match |
|---|---|---|---|---|---|
| Diphenoxylate | 9170 | II | Yes | None | Listed by name |
| Diphenoxylate preparations 2.5 mg/25 ug AtSO4 | None | V | Yes | Lomotil; Logen | Listed combination or preparation |
Diphenoxylate and Atropine NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0025-0061 | Lomotil | tablet | 2.5 mg/1; .025 mg/1 | Pfizer Laboratories Div Pfizer Inc | CV |
| 0054-3194 | Diphenoxylate Hydrochloride and Atropine Sulfate | solution | 2.5 mg/5mL; .025 mg/5mL | Hikma Pharmaceuticals USA Inc. | CV |
| 0406-1236 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | SpecGx LLC | CV |
| 43353-083 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | CV |
| 43353-594 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | CV |
| 50090-3456 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | A-S Medication Solutions | CV |
| 50090-5589 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | A-S Medication Solutions | CV |
| 50090-5592 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | A-S Medication Solutions | CV |
| 59762-1061 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Mylan Pharmaceuticals Inc. | CV |
| 60687-890 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | American Health Packaging | CV |
| 62135-618 | Diphenoxylate hydrochloride and atropine sulfate | tablet | 2.5 mg/1; .025 mg/1 | Chartwell RX, LLC | CV |
| 62559-490 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | ANI Pharmaceuticals, Inc. | CV |
| 63187-939 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Proficient Rx LP | CV |
| 67296-1485 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Redpharm Drug Inc. | CV |
| 67296-2240 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Redpharm Drug | CV |
| 68071-4063 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | NuCare Pharmaceuticals,Inc. | CV |
| 68788-8090 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Preferred Pharmaceuticals Inc. | CV |
| 69315-910 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Leading Pharma, LLC | CV |
| 70518-3915 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | REMEDYREPACK INC. | CV |
| 71205-909 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Proficient Rx LP | CV |
| 71335-0311 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Bryant Ranch Prepack | CV |
| 71335-1693 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Bryant Ranch Prepack | CV |
| 71610-714 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | CV |
| 71610-809 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | CV |
| 72189-336 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | tablet | 2.5 mg/1; .025 mg/1 | Direct Rx | CV |
| 72789-375 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | PD-Rx Pharmaceuticals, Inc. | CV |
| 75826-107 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Winder Laboratories LLC | CV |
| 76385-107 | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet | 2.5 mg/1; .025 mg/1 | Unichem Pharmaceuticals (USA), Inc. | CV |
Questions
Is diphenoxylate and atropine a controlled substance?
Yes. Diphenoxylate and atropine is a Schedule V controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Diphenoxylate preparations 2.5 mg/25 ug AtSO4 (Schedule V).
Is diphenoxylate and atropine a narcotic?
Yes. The DEA list marks diphenoxylate and atropine as a narcotic (NARC = Y) and places it in Schedule V. Its FDA established pharmacologic class is Anticholinergic and Antidiarrheal and Cholinergic Muscarinic Antagonist.
What schedule is diphenoxylate and atropine?
Diphenoxylate and atropine is Schedule V in the FDA NDC directory, which matches the DEA controlled substances list.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.
More on Diphenoxylate and Atropine
- What is Diphenoxylate and Atropine used for?FDA label uses
- Generic for LomotilFDA Orange Book
- What is Lomotil used for?FDA label uses
- Is Lomotil a controlled substance?Schedule V
- Anticholinergics listFDA drug class
- Antidiarrheals listFDA drug class
- Cholinergic Muscarinic Antagonists listFDA drug class
- NDC 0025-0061Diphenoxylate and Atropine NDC record
- NDC 0054-3194Diphenoxylate and Atropine NDC record
- NDC 0406-1236Diphenoxylate and Atropine NDC record
- Schedule V drugs listDEA schedule