United States· US:69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7
Naproxen Sodium and Diphenhydramine HCl
A naproxen and diphenhydramine product containing naproxen sodium; diphenhydramine hydrochloride, registered in United States by Amneal Pharmaceuticals NY 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; DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Country
- United States (US)
- ATC code
- M01AE57
- ATC class
- Naproxen and diphenhydramine
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 8
- ndc1169238142221 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE
- ndc1169238142241 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE
- ndc1169238142261 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE
- ndc1169238142281 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE
- ndc1169238-1422-2
- ndc1169238-1422-4
- ndc1169238-1422-6
- ndc1169238-1422-8
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Naproxen and diphenhydramine in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/c41a8143-52cb-4a00-a6f9-d85792da448b GET /v1/drugs/c41a8143-52cb-4a00-a6f9-d85792da448b?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; 25",
"substance": "NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE",
"productndc": "69238-1422",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA209726",
"marketing_category": "ANDA"
}See everything about naproxen and diphenhydramine.
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.