Diphenhydramine

Calmaben, Dermodrin, Dibondrin, Noctor · ATC code R06AA02

Also known as: Diphenhydramin, Difenhidramin · Brand names: Calmaben, Dermodrin, Dibondrin, Noctor, Nodisen, Betadorm-D, Diphenhydramin Hevert, Diphenhydraminhydrochlorid Stada, Dolestan Forte Zur Anwendung Bei Erwachsenen, Dormutil N, Emesan, Halbmond, Hemodorm, Schlaf Tabs, Schlaftabletten …

Key facts
Active substance
Diphenhydramine
Drug class
Histamine antagonist
ATC code
R06AA02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Diphenhydramine is a sedating H1 antihistamine. Per the US prescribing information, it is used orally for allergic reactions, motion sickness, parkinsonism and as a nighttime sleep-aid.

What it is used for

  • Allergic conditions: food-related conjunctivitis, mild urticaria and angioedema, dermatographism, reactions to blood or plasma
  • Adjunct in anaphylaxis after epinephrine once acute manifestations are controlled
  • Active and prophylactic treatment of motion sickness
  • Parkinsonism (including drug-induced)
  • Nighttime sleep-aid

Dosing

  • Dosage individualised to need and response
  • Adults: 25 to 50 mg three or four times daily; sleep-aid 50 mg at bedtime
  • Children (other than neonates and premature infants): 12.5 to 25 mg three or four times daily, not exceeding 300 mg daily
  • Motion sickness: first dose 30 minutes before exposure to motion
  • No data on use as a sleep-aid in children under 12 years

Contraindications

  • Neonates and premature infants
  • Nursing mothers
  • Hypersensitivity to diphenhydramine or antihistamines of similar chemical structure

Important warnings

  • Caution in narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction
  • Children: overdosage may cause hallucinations, convulsions or death; excitation possible
  • Elderly: more likely to cause dizziness, sedation and hypotension
  • May diminish mental alertness

Side effects

  • Sedation, sleepiness, dizziness, disturbed coordination
  • Dry mouth, thickening of bronchial secretions, epigastric distress
  • Hypotension, palpitations, tachycardia
  • Urinary retention, blurred vision, confusion
  • Serious: anaphylactic shock, hemolytic anemia, agranulocytosis, convulsions

Pregnancy and breastfeeding

  • Contraindicated in nursing mothers because of the risk to infants

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • CalmabenPharmazeutische Fabrik Montavit Ges.M.B.H. · 1 register entry
  • DermodrinPharmazeutische Fabrik Montavit Ges.M.B.H. · 1 register entry
  • DibondrinPharmazeutische Fabrik Montavit Ges.M.B.H. · 2 register entries
  • NoctorWabosan Arzneimittelvertriebs Gmbh · 1 register entry
  • NodisenPolfarmex S.A. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Betadorm-DRecordati Pharma Gmbh · 1 register entry
  • Diphenhydramin HevertHevert-Arzneimittel Gmbh & Co. Kg · 1 register entry
  • Diphenhydraminhydrochlorid StadaStada Consumer Health Deutschland Gmbh · 1 register entry
  • Dolestan Forte Zur Anwendung Bei ErwachsenenHolsten Pharma Gmbh · 1 register entry
  • Dormutil NPuren Pharma Gmbh & Co. Kg · 1 register entry
  • EmesanAristo Pharma Gmbh (Art 57) · 1 register entry
  • HalbmondCheplapharm Arzneimittel Gmbh · 1 register entry
  • HemodormHemopharm Gmbh · 1 register entry
  • Schlaf TabsHevert-Arzneimittel Gmbh & Co. Kg · 1 register entry
  • SchlaftablettenHeumann Pharma Gmbh & Co. Generica Kg, Fairmed Healthcare Gmbh, Dr. Pfleger Arzneimittel Gmbh · 3 register entries
  • SediatDr. Pfleger Arzneimittel Gmbh · 1 register entry
  • Vivinox Sleep SchlafdrageesDr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh · 1 register entry
Show all 13 brand names
  • Vivinox® Sleep Schlaftabletten StarkDr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AllenikGALEN İLAÇ SAN.VE TİC.A.Ş · 1 register entry
  • AllerjinGÜNSA GÜNEY İLAÇ VE HAMMADDELER SAN. VE TİC. A.Ş. · 1 register entry
  • BenisonOSEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • FenotralUMUT İLAÇ TİC. VE SAN. LTD. ŞTİ., MÜNİR ŞAHİN İLAÇ SAN. VE TİC A.Ş. · 2 register entries
  • HydryllinALİ RAİF İLAÇ SAN. A.Ş. · 1 register entry
  • Pectal EkspektoranSANTA FARMA İLAÇ SAN. A.Ş. · 1 register entry
  • Pectal PediyatrikSANTA FARMA İLAÇ SAN. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 17 more European countries
Belgium
Nustasium, R Calm
Bulgaria
Дермодрин, Калмабен, Псило Балсам
Czechia
Psilo-Balsam
Denmark
Benylan, Coldycof
Hungary
Supraderm
Iceland
Benylan
Ireland
Nytol One-A-Night
Italy
Allergan
Latvia
Pretniezes, Psilo-Balsam
Lithuania
Psilo-Balsam
Luxembourg
Nustasium
Poland
Luminastil, Nodisen, Senolek
Portugal
Benaderma, Benergina, Difenidramina Omega Pharma, Drenoflux
Romania
Calmaben, Dermodrin, Rival
Slovakia
Calmaben, Psilo-Balsam
Spain
Neosayomol, Soñodor
Sweden
Desentol

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

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Sources

  1. U.S. Food and Drug Administration. Diphenhydramine HCL (Redmont Pharmaceuticals, LLC) – Prescribing Information, 2026-08-03. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d8944f3c-acef-4ebe-9633-7d641ae95edf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC R06AA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.