United States· US:55758-435_227ba7f7-a051-50ad-e063-6394a90a74d6
DoloDent Toothache
A medicinal product containing caffeine; acetaminophen, registered in United States by Pharmadel LLC.
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
- CAFFEINE; ACETAMINOPHEN
- Manufacturer
- Pharmadel 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 · 2
- ndc1155758435241 BOTTLE in 1 CARTON (55758-435-24) / 24 TABLET in 1 BOTTLE
- ndc1155758-435-24
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Caffeine; acetaminophen in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaPARACETAMOL/KOFEIN DR. MÜLLER PHARMADr. Müller Pharma s.r.o., Hradec Králové
- PolandFERVEX ból i gorączka DUOUPSA SAS
- CanadaEXTRA STRENGTH TYLENOL DAYTIME RELIEFMCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
- United KingdomBeechams Cold Relief Orange Flavour effervescent tabletsHaleon UK Trading Ltd
- IrelandPanadol Cold and Flu Relief 500mg/65mg Film-Coated TabletsHaleon Ireland Limited
- GermanyAzurAristo Pharma Gmbh (Art 57)
- FranceCEFALINE HAUTH 500 mg/50 mg, comprimé pelliculé sécableLABORATOIRE DE L'HOMME DE FER
- FinlandPanadol CoffeinHaleon Denmark ApS
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Vivimed
- Belgium · Algostase, Croix Blanche
- Bulgaria · Парацетамол Екстра Химакс Фарма, Тайлол Плюс
- Cyprus · Algofen Duofast, Panadol Extra
- Czechia · Panadol Extra, Panadol Extra Rapide
- Germany · Azur, Octadon P
- Denmark · Arax Extra, Panodil Extra
- Estonia · Paramax Extra, Solpadeine Express
- Spain · Gelocatil Plus, Paracetamol/Cafeína Pharmaclan
- Finland · Panadol Coffein, Panadol Comp
- France · Cefaline Hauth, Claradol Cafeine
- United Kingdom (Northern Ireland) · Beechams Cold Relief Orange Flavour, Best-In Paracetamol Extra Pain Relief
- Greece · Algine, Apotel Εχτrα
- Croatia · Panadol Extra, Panadol Extra Optizorb
- Hungary · Miralgin, Panadol Rapid Extra
- Ireland · Panadol Cold And Flu Relief, Panadol Cold And Flu Relief Orange
- Iceland · Panodil Extra
- Italy · Tachicaf
- Lithuania · Paramax Extra, Solpadeine Express
- Luxembourg · Algostase, Croix Blanche
- Latvia · Paramax Extra, Solpadeine Pk
- Malta · Algofen Duofast, Apotel Extra
- Netherlands · Finimal, Panadol Plus Gladde Tablet
- Norway · Panodil-Duo, Paracetduo
- Poland · Apap Extra, Apap Nbg
- Portugal · Algik, Almigripe
- Romania · Extradol, Fervex Durere Și Febră Extra
- Sweden · Alvedon Comp, Paracoff
- Slovenia · Panadol Combo, Panadol Extra
- Slovakia · Panadol Extra, Panadol Extra Rapide
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/a8681c49-d7a5-4925-aef7-dc5004edf06c GET /v1/drugs/a8681c49-d7a5-4925-aef7-dc5004edf06c?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": "65; 500",
"substance": "CAFFEINE; ACETAMINOPHEN",
"productndc": "55758-435",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "M013",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about caffeine; 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.