Diphenhydramine is a histamine-1 receptor antagonist sold in the U.S. under 4 brand and generic names, for anxiety disorders, sleep initiation and maintenance disorders and motion sickness. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Benadryl Preservative Free (application NDA009486). Other diphenhydramine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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.
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.
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.
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $0 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| S4 | 25 mg | pink | capsule | — |
| CPC752 | 25 mg / 500 mg | blue | oval | — |
| L050 | 38 mg / 200 mg | blue | oval | — |
| DI;200 | 200 mg / 38 mg | blue | capsule | — |
| L050 | 38 mg / 200 mg | blue | oval | — |
| MOTRIN;PM | 200 mg / 38 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules…
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Chattem Inc · Mar 26, 2025
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x…
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Chattem Inc · Mar 4, 2025
Diphenhydramine HCl 50 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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.
| 3 | Not yet rated | Prescription | Syrup | Generic | $0 | View → |
| 4 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |
| white |
| oval |
| — |
| ALEVE;PM | 25 mg / 220 mg | blue | oval | — |
|---|
| L050 | 38 mg / 200 mg | blue | oval | — |
|---|