United States· US:28595-310_3001043a-7932-0867-e063-6294a90a91e6
HISTEX-DM New Formulation
A medicinal product containing dextromethorphan hydrobromide; pseudoephedrine hydrochloride; triprolidine hydrochloride, registered in United States by Allegis Pharmaceuticals, 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
- DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
- Manufacturer
- Allegis Pharmaceuticals, 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
- ndc1128595-310-16
- ndc112859531016473 mL in 1 BOTTLE (28595-310-16)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dextromethorphan hydrobromide; pseudoephedrine hydrochloride; triprolidine hydrochloride in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainCINFATOS DESCONGESTIVO SOLUCION ORALLaboratorios Cinfa S.A.
- PolandACTI-trinPrzedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A.
- IrelandBenylin Dual Action Dry Syrup, Pseudoephedrine 30mg, Dextromethorphan 10mg, Triprolidine 1.25mgJNTL Consumer Health I (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Spain · Cinfatós Descongestivo
- United Kingdom (Northern Ireland) · Multi-Action Actifed Dry Coughs
- Ireland · Benylin Dual Action Dry
- Italy · Actifed Composto
- Poland · Acti-Trin, Actifed
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/4701e7eb-04b9-45ba-bf85-0a86dcc0f1e5 GET /v1/drugs/4701e7eb-04b9-45ba-bf85-0a86dcc0f1e5?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": "20; 30; 2.5",
"substance": "DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE",
"productndc": "28595-310",
"dosage_form": "SYRUP",
"dea_schedule": null,
"strength_unit": "mg/5mL; mg/5mL; mg/5mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about dextromethorphan hydrobromide; pseudoephedrine hydrochloride; triprolidine 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.