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United States· US:51662-1219_11ffb76f-6e96-cf3c-e063-6294a90aa8df

DIPHENHYDRAMINE HYDROCHLORIDE

A medicinal product containing diphenhydramine hydrochloride, registered in United States by HF Acquisition Co. LLC, DBA Health First.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDIPHENHYDRAMINE HYDROCHLORIDEATC—REGISTER NO.US:51662-1219_11ffb76…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
HF Acquisition Co. LLC, DBA Health First
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 · 4

  • ndc11
    5166212191
    1 mL in 1 VIAL (51662-1219-1)
  • ndc11
    5166212193
    25 POUCH in 1 CASE (51662-1219-3) / 1 mL in 1 POUCH (51662-1219-2)
  • ndc11
    51662-1219-1
  • ndc11
    51662-1219-3

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.

All diphenhydramine hydrochloride products

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/c2a76d4b-87fd-4bfe-9e94-9e528ddacefb
GET /v1/drugs/c2a76d4b-87fd-4bfe-9e94-9e528ddacefb?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": "51662-1219",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA080817",
  "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.