Diphenhydramine hydrochloride

Capsule · Oral, Intramuscular, Intravenous

Over the counter Histamine-1 Receptor Antagonist 2 recalls

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 to four times daily. The nightime sleep aid dosage is 50 mg at bedtime. Pediatric Patients, other than premature infants and neonates 12.5 mg 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

Label text from the FDA structured product label by Camber Pharmaceuticals, Inc. (revised Jul 4, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Diphenhydramine hydrochloride NDC products (81)

NDCStrength & formLabelerType
50090-0878Diphenhydramine Hcl 50 mg/mL
Injection		A-S Medication SolutionsANDA
50090-1841Diphenhydramine Hcl 50 mg/mL
Injection		A-S Medication SolutionsANDA
72485-101Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		Armas Pharmaceuticals Inc.ANDA
31722-601Diphenhydramine Hydrochloride 25 mg/10mL
Solution		Camber Pharmaceuticals, Inc.ANDA
31722-600Diphenhydramine Hydrochloride 12.5 mg/5mL
Solution		Camber Pharmaceuticals, Inc.ANDA
55154-5102Diphenhydramine Hydrochloride 50 mg/mL
Injection		Cardinal Health 107, LLCANDA
55154-9363Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		Cardinal Health 107, LLCANDA
76045-235Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		Fresenius Kabi USA, LLCANDA
76045-102Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		Fresenius Kabi USA, LLCANDA
68083-611Diphenhydramine Hydrochloride 50 mg/mL
Injection		Gland Pharma LimitedANDA
0404-9851Diphenhydramine Hydrochloride 50 mg/mL
Injection		Henry Schein, Inc.ANDA
23155-264Diphenhydramine Hydrochloride 50 mg/mL
Injection		Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDA
23155-263Diphenhydramine Hydrochloride 50 mg/mL
Injection		Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDA
51662-1348Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		HF Acquisition Co LLC, DBA HealthFirstANDA
51662-1374Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		HF Acquisition Co LLC, DBA HealthFirstANDA
51662-1219Diphenhydramine Hydrochloride 50 mg/mL
Injection		HF Acquisition Co. LLC, DBA Health FirstANDA
0641-0376Diphenhydramine Hydrochloride 50 mg/mL
Injection		Hikma Pharmaceuticals USA Inc.ANDA
0641-6282Diphenhydramine Hydrochloride 50 mg/mL
Injection		Hikma Pharmaceuticals USA Inc.ANDA
71872-7180Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		Medical Purchasing Solutions, LLCANDA
71872-7373Diphenhydramine Hydrochloride 50 mg/mL
Injection		Medical Purchasing Solutions, LLCANDA
71872-7242Diphenhydramine Hydrochloride 25 mg/10mL
Solution		Medical Purchasing Solutions, LLCANDA
71872-7005Diphenhydramine Hydrochloride 50 mg/mL
Injection		Medical Purchasing Solutions, LLCANDA
42571-511Diphenhydramine Hydrochloride 50 mg/mL
Injection		Micro Labs LimitedANDA
0121-0489Diphenhydramine Hydrochloride 12.5 mg/5mL
Solution		PAI Holdings, LLC dba PAI PharmaANDA
0121-0978Diphenhydramine Hydrochloride 25 mg/10mL
Solution		PAI Holdings, LLC dba PAI PharmaANDA
84549-101Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		ProPharma DistributionANDA
70518-4536Diphenhydramine Hydrochloride 50 mg/mL
Injection		REMEDYREPACK INC.ANDA
70518-4455Diphenhydramine Hydrochloride 50 mg/mL
Injection		REMEDYREPACK INC.ANDA
70518-1082Diphenhydramine Hydrochloride 50 mg/mL
Injection		REMEDYREPACK INC.ANDA
25021-481Diphenhydramine Hydrochloride 50 mg/mL
Injection, Solution		Sagent PharmaceuticalsANDA
85766-253Diphenhydramine Hydrochloride 50 mg/mL
Injection		Sportpharm LLCANDA
14803-903Diphenhydramine Hydrochloride 50 mg/1
Capsule		Elysium Pharmaceuticals LimitedDRUG FOR FURTHER PROCESSING
50090-7014Diphenhydramine Hydrochloride 25 mg/1
Capsule		A-S Medication SolutionsOTC MONOGRAPH DRUG
57344-091Diphenhydramine Hydrochloride 25 mg/1
Tablet, Coated		AAA Pharmaceutical, Inc.OTC MONOGRAPH DRUG
73629-007Diphenhydramine Hydrochloride 25 mg/1
Capsule, Liquid Filled		AMZ789 LLCOTC MONOGRAPH DRUG
37835-641Diphenhydramine Hydrochloride 25 mg/1
Tablet		Bi-MartOTC MONOGRAPH DRUG
71335-2257Diphenhydramine Hydrochloride 25 mg/1
Capsule		Bryant Ranch PrepackOTC MONOGRAPH DRUG
55154-2344Diphenhydramine Hydrochloride 25 mg/1
Capsule		Cardinal Health 107, LLCOTC MONOGRAPH DRUG
55154-1589Diphenhydramine Hydrochloride 25 mg/1
Tablet		Cardinal Health 107, LLCOTC MONOGRAPH DRUG
69842-981Diphenhydramine Hydrochloride 25 mg/1
Tablet, Film Coated		CVS Pharmacy, IncOTC MONOGRAPH DRUG
51316-347Diphenhydramine Hydrochloride 25 mg/1
Capsule		CVS Pharmacy, IncOTC MONOGRAPH DRUG
51316-835Diphenhydramine Hydrochloride 25 mg/1
Capsule		CVS Pharmacy, IncOTC MONOGRAPH DRUG
69842-825Diphenhydramine Hydrochloride 25 mg/1
Capsule		CVS Pharmacy, Inc.OTC MONOGRAPH DRUG
69842-834Diphenhydramine Hydrochloride 25 mg/1
Tablet, Film Coated		CVS Pharmacy, Inc.OTC MONOGRAPH DRUG
71679-311Diphenhydramine Hydrochloride 25 mg/1
Tablet, Film Coated		Health Pharma USA LLCOTC MONOGRAPH DRUG
71679-308Diphenhydramine Hydrochloride 25 mg/1
Tablet, Film Coated		Health Pharma USA LLCOTC MONOGRAPH DRUG
51662-1674Diphenhydramine Hydrochloride 25 mg/1
Tablet, Film Coated		HF Acquisition Co LLC, DBA HealthFirstOTC MONOGRAPH DRUG
51662-1628Diphenhydramine Hydrochloride 25 mg/1
Capsule		HF Acquisition Co LLC, DBA HealthFirstOTC MONOGRAPH DRUG
53345-005Diphenhydramine Hydrochloride 50 mg/1
Capsule, Liquid Filled		Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.OTC MONOGRAPH DRUG
53345-007Diphenhydramine Hydrochloride 25 mg/1
Capsule, Liquid Filled		Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.OTC MONOGRAPH DRUG
53345-022Diphenhydramine Hydrochloride 50 mg/1
Capsule, Liquid Filled		Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.OTC MONOGRAPH DRUG
53345-027Diphenhydramine Hydrochloride 25 mg/1
Capsule, Liquid Filled		Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.OTC MONOGRAPH DRUG
53345-002Diphenhydramine Hydrochloride 25 mg/1
Capsule, Liquid Filled		Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.OTC MONOGRAPH DRUG
70000-0598Diphenhydramine Hydrochloride 25 mg/1
Capsule		LEADER/ Cardinal Health 110, Inc.OTC MONOGRAPH DRUG
0904-2056Diphenhydramine Hydrochloride 50 mg/1
Capsule		Major PharmaceuticalsOTC MONOGRAPH DRUG
0904-7237Diphenhydramine Hydrochloride 25 mg/1
Capsule		Major PharmaceuticalsOTC MONOGRAPH DRUG
83720-502Diphenhydramine Hydrochloride 12.5 mg/5mL
Solution		Oncor PharmaceuticalsOTC MONOGRAPH DRUG
72789-317Diphenhydramine Hydrochloride 25 mg/1
Capsule		PD-Rx Pharmaceuticals, Inc.OTC MONOGRAPH DRUG
68094-018Diphenhydramine Hydrochloride 25 mg/1
Tablet		Precision Dose, Inc.OTC MONOGRAPH DRUG
68788-8855Diphenhydramine Hydrochloride 25 mg/1
Capsule		Preferred Pharmaceuticals Inc.OTC MONOGRAPH DRUG
68210-5057Diphenhydramine Hydrochloride 50 mg/1
Capsule, Liquid Filled		Prodose, Inc.OTC MONOGRAPH DRUG
54738-115Diphenhydramine Hydrochloride 25 mg/1
Capsule		Richmond Pharmaceuticals, Inc.OTC MONOGRAPH DRUG
76457-002Diphenhydramine Hydrochloride 25 mg/1
Tablet		Simpex Pharma Pvt. LtdOTC MONOGRAPH DRUG
35916-0438Diphenhydramine Hydrochloride 50 mg/1
Capsule, Liquid Filled		SOFTGEL HEALTHCARE PRIVATE LIMITEDOTC MONOGRAPH DRUG
35916-0436Diphenhydramine Hydrochloride 25 mg/1
Capsule, Liquid Filled		SOFTGEL HEALTHCARE PRIVATE LIMITEDOTC MONOGRAPH DRUG
35916-0435Diphenhydramine Hydrochloride 25 mg/1
Capsule, Liquid Filled		SOFTGEL HEALTHCARE PRIVATE LIMITEDOTC MONOGRAPH DRUG
35916-0471Diphenhydramine Hydrochloride 25 mg/1
Capsule, Liquid Filled		SOFTGEL HEALTHCARE PRIVATE LIMITEDOTC MONOGRAPH DRUG
35916-0470Diphenhydramine Hydrochloride 50 mg/1
Capsule, Liquid Filled		Softgel Healthcare Pvt LtdOTC MONOGRAPH DRUG
35916-0472Diphenhydramine Hydrochloride 50 mg/1
Capsule, Liquid Filled		Softgel Healthcare Pvt LtdOTC MONOGRAPH DRUG
60760-697Diphenhydramine Hydrochloride 25 mg/1
Capsule		St. Mary's Medical Park PharmacyOTC MONOGRAPH DRUG
70692-785Diphenhydramine Hydrochloride 50 mg/1
Capsule, Liquid Filled		Strive Pharmaceuticals Inc.OTC MONOGRAPH DRUG
0363-8350Diphenhydramine Hydrochloride 25 mg/1
Capsule		Walgreen CompanyOTC MONOGRAPH DRUG
0363-9835Diphenhydramine Hydrochloride 25 mg/1
Capsule		Walgreen CompanyOTC MONOGRAPH DRUG
17714-020Diphenhydramine Hydrochloride 25 mg/1
Capsule		Advance Pharmaceutical Inc.OTC MONOGRAPH FINAL
17714-021Diphenhydramine Hydrochloride 50 mg/1
Capsule		Advance Pharmaceutical Inc.OTC MONOGRAPH FINAL
17714-023Diphenhydramine Hydrochloride 50 mg/1
Tablet		Advance Pharmaceutical Inc.OTC MONOGRAPH FINAL
17714-135Diphenhydramine Hydrochloride 25 mg/1
Tablet		Advance Pharmaceutical Inc.OTC MONOGRAPH FINAL
42806-648Diphenhydramine Hydrochloride 25 mg/1
Capsule		Epic Pharma, LLCOTC MONOGRAPH FINAL
42806-649Diphenhydramine Hydrochloride 50 mg/1
Capsule		Epic Pharma, LLCOTC MONOGRAPH FINAL
54738-116Diphenhydramine Hydrochloride 50 mg/1
Capsule		Richmond Pharmaceuticals, Inc.OTC MONOGRAPH FINAL
49483-329Diphenhydramine Hydrochloride 25 mg/1
Tablet, Coated		Time-Cap Labs, IncOTC MONOGRAPH FINAL

Diphenhydramine hydrochloride recalls

Frequently asked questions

What is Diphenhydramine hydrochloride 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 hydrochloride?

Diphenhydramine hydrochloride is listed by 44 labelers in the FDA NDC directory, including A-S Medication Solutions, Armas Pharmaceuticals Inc., Camber Pharmaceuticals, Inc., Cardinal Health 107, LLC.

Has Diphenhydramine hydrochloride been recalled?

The FDA enforcement database lists 2 recalls for Diphenhydramine hydrochloride, most recently D-1101-2022 (class ii): cGMP deviations: Temperature abuse