United States· US:58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold
A medicinal product containing naproxen sodium; pseudoephedrine hydrochloride, registered in United States by Aurohealth 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
- NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
- Manufacturer
- Aurohealth 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 · 6
- ndc1158602-816-67
- ndc1158602-816-72
- ndc1158602-816-83
- ndc1158602816672 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602816723 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602816831 BLISTER PACK in 1 CARTON (58602-816-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/ddede314-32c0-4ab8-9df4-755539eccd89 GET /v1/drugs/ddede314-32c0-4ab8-9df4-755539eccd89?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": "220; 120",
"substance": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
"productndc": "58602-816",
"dosage_form": "TABLET, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA211360",
"marketing_category": "ANDA"
}See everything about naproxen sodium; 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.