DEA schedule
Is diphenhydramine a controlled substance?
Federal schedule for diphenhydramine from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Diphenhydramine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and diphenhydramine is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 39 prescription listings from 20 labelers, none with a DEA schedule |
| DEA controlled substances list | diphenhydramine is not on the list |
Diphenhydramine NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 42571-169 | DIPHENHYDRAMINE | injection, solution | 50 mg/mL | Micro Labs Limited | None |
| 42571-337 | DIPHENHYDRAMINE | injection, solution | 50 mg/mL | Micro Labs Limited | None |
| 63323-664 | Diphenhydramine | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 63323-664 | Diphenhydramine | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 65219-820 | Diphenhydramine | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 70518-4765 | DIPHENHYDRAMINE | injection, solution | 50 mg/mL | REMEDYREPACK INC. | None |
| 83634-781 | Diphenhydramine | injection, solution | 50 mg/mL | Avenacy, LLC | None |
| 71741-511 | Diphenhydramine HCL | solution | 12.5 mg/5mL | Redmont Pharmaceuticals, LLC | None |
| 0404-9851 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Henry Schein, Inc. | None |
| 0641-0376 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Hikma Pharmaceuticals USA Inc. | None |
| 0641-6282 | Diphenhydramine hydrochloride | injection | 50 mg/mL | Hikma Pharmaceuticals USA Inc. | None |
| 23155-263 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | None |
| 23155-264 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | None |
| 42571-511 | DIPHENHYDRAMINE HYDROCHLORIDE | injection | 50 mg/mL | Micro Labs Limited | None |
| 50090-0878 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | A-S Medication Solutions | None |
| 50090-1841 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | A-S Medication Solutions | None |
| 51662-1219 | DIPHENHYDRAMINE HYDROCHLORIDE | injection | 50 mg/mL | HF Acquisition Co. LLC, DBA Health First | None |
| 55154-5102 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Cardinal Health 107, LLC | None |
| 68083-611 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Gland Pharma Limited | None |
| 70518-1082 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | REMEDYREPACK INC. | None |
| 70518-4455 | Diphenhydramine hydrochloride | injection | 50 mg/mL | REMEDYREPACK INC. | None |
| 70518-4536 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | REMEDYREPACK INC. | None |
| 71872-7005 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Medical Purchasing Solutions, LLC | None |
| 71872-7373 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Medical Purchasing Solutions, LLC | None |
| 85766-253 | Diphenhydramine Hydrochloride | injection | 50 mg/mL | Sportpharm LLC | None |
| 25021-481 | Diphenhydramine Hydrochloride | injection, solution | 50 mg/mL | Sagent Pharmaceuticals | None |
| 51662-1348 | DIPHENHYDRAMINE HYDROCHLORIDE | injection, solution | 50 mg/mL | HF Acquisition Co LLC, DBA HealthFirst | None |
| 51662-1374 | DIPHENHYDRAMINE HYDROCHLORIDE | injection, solution | 50 mg/mL | HF Acquisition Co LLC, DBA HealthFirst | None |
| 55154-9363 | Diphenhydramine Hydrochloride | injection, solution | 50 mg/mL | Cardinal Health 107, LLC | None |
| 71872-7180 | Diphenhydramine Hydrochloride | injection, solution | 50 mg/mL | Medical Purchasing Solutions, LLC | None |
| 72485-101 | Diphenhydramine Hydrochloride | injection, solution | 50 mg/mL | Armas Pharmaceuticals Inc. | None |
| 76045-102 | Diphenhydramine Hydrochloride | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 76045-235 | Diphenhydramine Hydrochloride | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 84549-101 | Diphenhydramine Hydrochloride | injection, solution | 50 mg/mL | ProPharma Distribution | None |
| 0121-0489 | DIPHENHYDRAMINE HYDROCHLORIDE | solution | 12.5 mg/5mL | PAI Holdings, LLC dba PAI Pharma | None |
| 31722-600 | Diphenhydramine hydrochloride | solution | 12.5 mg/5mL | Camber Pharmaceuticals, Inc. | None |
| 0121-0978 | DIPHENHYDRAMINE HYDROCHLORIDE | solution | 25 mg/10mL | PAI Holdings, LLC dba PAI Pharma | None |
| 31722-601 | Diphenhydramine hydrochloride | solution | 25 mg/10mL | Camber Pharmaceuticals, Inc. | None |
| 71872-7242 | DIPHENHYDRAMINE HYDROCHLORIDE | solution | 25 mg/10mL | Medical Purchasing Solutions, LLC | None |
Questions
Is diphenhydramine a controlled substance?
No. Diphenhydramine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and diphenhydramine is not on the DEA controlled substances list.
Is diphenhydramine a narcotic?
No. Diphenhydramine is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Histamine-1 Receptor Antagonist.
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 Diphenhydramine
- What is Diphenhydramine used for?FDA label uses
- Generic for BenadrylFDA Orange Book
- Generic for Benadryl Preservative FreeFDA Orange Book
- Histamine-1 Receptor Antagonists listFDA drug class
- NDC 0121-0489Diphenhydramine NDC record
- NDC 0121-0978Diphenhydramine NDC record
- NDC 0404-9851Diphenhydramine NDC record