Diphenhydramine HCL
Capsule · Oral
Uses
Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness. Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents. Nighttime Sleep-aid.
Warnings
Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction. Use in Pediatric Patients In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation. Use in the Elderly (approximately 60 years or older) Antihistamines are most likely to cause dizziness, sedation, and hypotension in elderly patients.
Dosage and administration
DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours. Adults 25 to 50 mg three or four times daily. The nighttime sleep-aid dosage is 50 mg at bedtime. Pediatric Patients, other than premature infants and neonates 12.5 to 25 mg three or four times daily. Maximum daily dosage not to exceed 300 mg. For physicians who wish to calculate the dose on the basis of body weight or surface area, the recommended dosage is 5 mg/kg/24 hours or 150 mg/m 2 /24 hours. Data are not available on the use of diphenhydramine hydrochloride as a nighttime sleep-aid in children under 12 years. The basis for determining the most effective dosage regimen will be the response of the patient to medication and the condition under treatment. In motion sickness, full dosage is recommended for prophylactic use, the first dose to be given 30 minutes before exposure to motion and similar doses before meals and upon retiring for the duration of exposure.
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing and light.
Label text from the FDA structured product label by Redmont Pharmaceuticals, LLC (revised Aug 3, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Diphenhydramine Hydrochloride in 36 products
- Diphenhydramine Hcl in 1 product
Diphenhydramine HCL NDC products (37)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 71741-511 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Redmont Pharmaceuticals, LLC | ANDA |
| 50090-5716 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 50090-5744 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 50090-6541 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 82568-0005 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | AARNA USA INC. | OTC MONOGRAPH DRUG |
| 82568-0004 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | AARNA USA INC. | OTC MONOGRAPH DRUG |
| 71399-1027 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | Akron Pharma Inc. | OTC MONOGRAPH DRUG |
| 71399-1028 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | Akron Pharma Inc. | OTC MONOGRAPH DRUG |
| 60687-829 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | American Health Packaging | OTC MONOGRAPH DRUG |
| 60687-830 | Diphenhydramine Hydrochloride 25 mg/10mL Solution | American Health Packaging | OTC MONOGRAPH DRUG |
| 84447-103 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Belleview Biosciences | OTC MONOGRAPH DRUG |
| 37835-519 | Diphenhydramine Hcl 50 mg/30mL Liquid | BI-MART | OTC MONOGRAPH DRUG |
| 37835-852 | Diphenhydramine Hydrochloride 50 mg/1 Tablet | Bi-Mart | OTC MONOGRAPH DRUG |
| 71335-0352 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | Bryant Ranch Prepack | OTC MONOGRAPH DRUG |
| 55154-0661 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | Cardinal Health 107, LLC | OTC MONOGRAPH DRUG |
| 69842-537 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | CVS Pharmacy, Inc. | OTC MONOGRAPH DRUG |
| 51316-221 | Diphenhydramine Hydrochloride 50 mg/1 Tablet, Coated | CVS Pharmacy, Inc. | OTC MONOGRAPH DRUG |
| 73376-003 | Diphenhydramine Hydrochloride 25 mg/25mg Tablet, Film Coated | INVAHEALTH INC | OTC MONOGRAPH DRUG |
| 0904-7560 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Major Pharmaceuticals | OTC MONOGRAPH DRUG |
| 0904-7559 | Diphenhydramine Hydrochloride 25 mg/10mL Solution | Major Pharmaceuticals | OTC MONOGRAPH DRUG |
| 0904-6985 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Major Pharmaceuticals | OTC MONOGRAPH DRUG |
| 66267-779 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 68071-3352 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 66267-081 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 68071-3877 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | OTC MONOGRAPH DRUG |
| 0121-0865 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | OTC MONOGRAPH DRUG |
| 0121-1730 | Diphenhydramine Hydrochloride 25 mg/10mL Solution | PAI Holdings, LLC dba PAI Pharma | OTC MONOGRAPH DRUG |
| 72789-532 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 55289-479 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 68788-8274 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Preferred Pharmaceuticals Inc. | OTC MONOGRAPH DRUG |
| 68788-9687 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | Preferred Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 68788-9688 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | Preferred Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 71205-615 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | Proficient Rx LP | OTC MONOGRAPH DRUG |
| 63187-866 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | Proficient Rx LP | OTC MONOGRAPH DRUG |
| 0536-1214 | Diphenhydramine Hydrochloride 25 mg/1 Tablet, Film Coated | Rugby Laboratories | OTC MONOGRAPH DRUG |
| 66424-021 | Diphenhydramine Hydrochloride 50 mg/1 Capsule | SDA Laboratories, Inc. | OTC MONOGRAPH DRUG |
| 66424-020 | Diphenhydramine Hydrochloride 25 mg/1 Capsule | SDA Laboratories, Inc. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Diphenhydramine HCL used for?
Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the…
Who makes Diphenhydramine HCL?
Diphenhydramine HCL is listed by 22 labelers in the FDA NDC directory, including Redmont Pharmaceuticals, LLC, A-S Medication Solutions, AARNA USA INC., Akron Pharma Inc..