United States· US:68083-611_89f09a33-2535-47c9-8942-dd8ebe5d3b4a
Diphenhydramine Hydrochloride
A medicinal product containing diphenhydramine hydrochloride, registered in United States by Gland Pharma Limited.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Gland Pharma Limited
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1168083-611-25
- ndc11680836112525 VIAL in 1 CARTON (68083-611-25) / 1 mL in 1 VIAL
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Diphenhydramine hydrochloride in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaALLERGY FORMULAJUNO OTC INC
- United KingdomAdult Meltus Night Time syrupSSL International Plc
- GermanyBetadorm-DRecordati Pharma Gmbh
- BelgiumAzaron 20 mg/g LotionPerrigo Belgium
- NorwayDiphenhydramine eonEon Labs
- SwitzerlandBenocten, TablettenMedinova AG
- PolandLuminastilAflofarm Farmacja Polska Sp. z o.o.
- SpainDIFENHIDRAMINA OMEGA PHARMA 50 MG COMPRIMIDOSOmega Pharma España, S.A.
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Austria · Calmaben, Dermodrin
- Belgium · Nustasium, R Calm
- Bulgaria · Дермодрин, Калмабен
- Czechia · Psilo-Balsam
- Germany · Betadorm-D, Diphenhydramin Hevert
- Denmark · Benylan, Coldycof
- Spain · Neosayomol, Soñodor
- United Kingdom (Northern Ireland) · Almus Max Strength Sleep Aid, Asda Night Time Sleep Aid
- Hungary · Supraderm
- Ireland · Nytol One-A-Night
- Iceland · Benylan
- Italy · Allergan
- Lithuania · Psilo-Balsam
- Luxembourg · Nustasium
- Latvia · Pretniezes, Psilo-Balsam
- Poland · Luminastil, Nodisen
- Portugal · Benaderma, Benergina
- Romania · Calmaben, Dermodrin
- Sweden · Desentol
- Slovakia · Calmaben, Psilo-Balsam
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/ab0fff56-1fd1-4a75-99ac-8cb2fd57724e GET /v1/drugs/ab0fff56-1fd1-4a75-99ac-8cb2fd57724e?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": "50",
"substance": "DIPHENHYDRAMINE HYDROCHLORIDE",
"productndc": "68083-611",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA218448",
"marketing_category": "ANDA"
}See everything about diphenhydramine hydrochloride.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.