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United States· US:68016-654_47f839b9-ac8b-161c-e054-00144ff8d46c

Acetaminophen Diphenhydramine HCl

A medicinal product containing acetaminophen; diphenhydramine, registered in United States by Chain Drug Consortium,LLC.

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…normalisedAcetaminophen Diphenhydramine HClATC—REGISTER NO.US:68016-654_47f839b9…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETAMINOPHEN; DIPHENHYDRAMINE
Manufacturer
Chain Drug Consortium,LLC
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
    68016-654-05
  • ndc11
    68016-654-10
  • ndc11
    6801665405
    50 TABLET in 1 BOTTLE (68016-654-05)
  • ndc11
    6801665410
    100 TABLET in 1 BOTTLE (68016-654-10)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Acetaminophen; diphenhydramine in 6 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All acetaminophen; diphenhydramine products

Authorised across Europe · EMA

The same active substance is authorised in 6 EEA countries. Names it is sold under:

  • Spain · Dolomidina
  • United Kingdom (Northern Ireland) · Panadol Night, Panadol Nightpain
  • Ireland · Dozol, Panadol Night
  • Malta · Dozol, Teedex
  • Poland · Apap Noc, Paracetamol + Difenhydramina Noc Hasco
  • Portugal · Algik Noite, Chrobion

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/bc904f58-5820-4944-96a7-a99160b0b25b
GET /v1/drugs/bc904f58-5820-4944-96a7-a99160b0b25b?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": "ORAL",
  "source": "ndc",
  "strength": "500; 25",
  "substance": "ACETAMINOPHEN; DIPHENHYDRAMINE",
  "productndc": "68016-654",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "part343",
  "marketing_category": "OTC MONOGRAPH NOT FINAL"
}

See everything about acetaminophen; diphenhydramine.

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.