Diphenhydramine 50 mg/mL
DIPHENHYDRAMINE HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Diphenhydramine is a injection, solution containing diphenhydramine hydrochloride at 50 mg/mL, taken intramuscular. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Diphenhydramine
- Generic Name
- DIPHENHYDRAMINE HYDROCHLORIDE
- NDC Code (Product)
65219-820- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA040466
- Marketing Start
- 05/05/2025
Recall History
Infusion Options, Inc.
Lack of Assurance of Sterility
Plastikon Healthcare LLC
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Plastikon Healthcare LLC
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Chattem Inc
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Mid Valley Pharmaceutical
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Aidapak Services, LLC
Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
InnovaGel
Subpotent
Akron Pharma, Inc.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Diphenhydramine hydrochloride injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness For active treatment of motion sickness. Antiparkinsonism For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride injection, USP is indicated when the oral form is impractical. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Pediatric Patients, Other Than Premature Infants and Neonates 5 mg/kg/24 hours or 150 mg/m 2 /24 hours. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly. Adults 10 mg to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly; 100 mg if required; maximum daily dosage is 400 mg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings
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. Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine. 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 more likely to cause dizziness, sedation and hypotension in elderly patients.
Contraindications
CONTRAINDICATIONS Use in Neonates or Premature Infants This drug should not be used in neonates or premature infants. Use in Nursing Mothers Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Use as a Local Anesthetic Because of the risk of local necrosis, this drug should not be used as a local anesthetic. Antihistamines are also Contraindicated in the Following Conditions Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.
Drug Interactions
Drug Interactions Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Adverse Reactions
ADVERSE REACTIONS The most frequent adverse reactions are italicized. General Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat. Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis. Nervous System Sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions. Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness. To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Diphenhydramine used for?
Diphenhydramine contains DIPHENHYDRAMINE HYDROCHLORIDE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Diphenhydramine a controlled substance?
Diphenhydramine is not classified as a controlled substance by the DEA.
What is the generic name for Diphenhydramine?
The generic name for Diphenhydramine is DIPHENHYDRAMINE HYDROCHLORIDE. There are 12 other brand versions of DIPHENHYDRAMINE HYDROCHLORIDE.
What is the NDC code for Diphenhydramine 50 mg/mL?
The NDC (National Drug Code) for Diphenhydramine 50 mg/mL is 65219-820, listed by Fresenius Kabi USA, LLC.
Other Diphenhydramine Brands
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- Sleep Aid25 mg/176168-015
- Allergy25 mg/176168-121
- NIGHTTIME SLEEP AID25 mg/179903-083
- Allergy Relief25 mg/183059-0021
- Banophen2 g/100g0904-5354
- Diphenhydramine Hydrochloride25 mg/10904-7237
- Nighttime Sleep Aid50 mg/30mL11673-285
- Anti-itch20 mg/g11673-895
- Topcare childrens allergy12.5 mg/5mL36800-379
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)