United States· US:49483-430_3a6f8b16-c8a2-7195-e063-6394a90ac5fd
Extra strength Acetaminophen PM
A medicinal product containing diphenhydramine hydrochloride; acetaminophen, registered in United States by TIME CAP LABS INC.
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; ACETAMINOPHEN
- Manufacturer
- TIME CAP LABS INC
- 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
- ndc114948343040400 TABLET in 1 BOTTLE (49483-430-40)
- ndc1149483-430-40
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Diphenhydramine hydrochloride; acetaminophen in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaACETAMINOPHEN WITH ANTIHISTAMINE NIGHTTIMELABORATOIRES TRIANON INC.
- United KingdomCalCold Six Plus oral solutionMcNeil Products Ltd
- IrelandDozol Oral Solution Paracetamol 120 mg/5 ml Diphenhydramine Hydrochloride 12.5 mg/5 mlPhoenix Healthcare Ltd
- PolandApap NocUS Pharmacia Sp. z o.o.
- SpainANTIDOL NOCHE 500 MG/25 MG COMPRIMIDOS RECUBIERTOS CON PELICULALaboratorios Cinfa S.A.
- FranceACTIFED RHUME JOUR ET NUIT, compriméKENVUE FRANCE
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/346aa9fc-9623-4713-ab5e-c83376a57a53 GET /v1/drugs/346aa9fc-9623-4713-ab5e-c83376a57a53?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": "25; 500",
"substance": "DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN",
"productndc": "49483-430",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "M013",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about diphenhydramine hydrochloride; acetaminophen.
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.