Diphenhydramine
Active ingredient · 2 therapeutic classes
Sold as Sleep Aid · Itch Relief · Nighttime Sleep Aid · dg health sleep aid · Allergy Childrens Allergy
- Drug class
- Aminoalkyl Ethers
- Availability
- Prescription and OTC
- Routes
- Oral, Topical, Intramuscular, Intravenous
- Markets covered
- 3
- Products on record
- 50
- FDA reports (12 mo)
- 9,019
Overview
Plain-language summary, compiled from the cited regulatory records
Diphenhydramine is an antihistamine used for topical applications [1]. It belongs to the drug class of antihistamines for topical use [1].
Diphenhydramine hydrochloride injection is approved for adults and pediatric patients, excluding premature infants and neonates, when oral administration is not practical [1]. It is indicated for the amelioration of allergic reactions to blood or plasma, as an adjunct to epinephrine and other standard measures in anaphylaxis after acute symptoms are controlled, and for other uncomplicated immediate allergic conditions when oral therapy is not suitable [1].
This active ingredient is available under various brand names, including Good Neighbor Pharmacy Childrens Allergy, Nighttime Sleep Aid, and basic care nighttime sleep aid [1]. In the last 12 months, there have been 9019 adverse event reports associated with diphenhydramine [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 27 | May 6, 2026 |
| GB United Kingdom | MHRA | 18 | May 29, 2026 |
| CA Canada | Health Canada | 5 | March 22, 2025 |
USUnited States· FDA
27 products
Uses
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.
GBUnited Kingdom· MHRA
18 products
Uses
An aid to the relief of temporary sleep disturbance
How to take
CACanada· Health Canada
5 products
5 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (2)
Drug interactions
Known interactions involving Diphenhydramine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 368. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 00f862aa-6917-45… · revised May 16, 2025 [PDF]
- [2]MHRA (UK) · PL028550071 · revised March 13, 2026
- [3]Health Canada (DPD) · 00596612 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.