United States· US:0363-0134_a8d412ac-63da-463b-a670-4d4c927b9782
Guaifenesin and Pseudoephedrine HCl
A medicinal product containing guaifenesin; pseudoephedrine hydrochloride, registered in United States by WALGREEN CO..
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
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Manufacturer
- WALGREEN CO.
- 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
- ndc1103630134782 BLISTER PACK in 1 CARTON (0363-0134-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc110363-0134-78
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Guaifenesin; pseudoephedrine hydrochloride in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAdult Meltus Chesty Cough with Decongestant oral solutionSSL International Plc
- SpainINISTON MUCOSIDAD Y CONGESTION 20 MG/ML + 6 MG/ML JARABEJntl Consumer Health (Spain) S.L.
- IrelandBenylin Phlegm Cough plus Decongestant SyrupGuaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/5 mlJNTL Consumer Health I (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Spain · Iniston Mucosidad Y Congestión, Respidina Expectorante Junior
- United Kingdom (Northern Ireland) · Benylin Mucus Cough Plus Decongestant, Boots Cough And Decongestant 6 Years +
- Ireland · Benylin Phlegm Cough Plus Decongestant, Robitussin Plus
- Romania · Bioflu Expectorant
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/ac7b9646-a9af-4ea4-8601-d08954309fe8 GET /v1/drugs/ac7b9646-a9af-4ea4-8601-d08954309fe8?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": "1200; 120",
"substance": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"productndc": "0363-0134",
"dosage_form": "TABLET, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA213203",
"marketing_category": "ANDA"
}See everything about guaifenesin; pseudoephedrine 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.