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United States· US:62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765

Naproxen Sodium and Diphenhydramine HCl

A naproxen and diphenhydramine product containing naproxen sodium; diphenhydramine hydrochloride, registered in United States by Granules India Ltd.

ATC M01AE57US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedNaproxen Sodium and Diphenhydramine H…ATCM01AE57REGISTER NO.US:62207-814_3b4ca636…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
Granules India Ltd
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

  • ndc11
    62207-814-38
  • ndc11
    62207-814-39
  • ndc11
    62207-814-47
  • ndc11
    62207-814-95
  • ndc11
    6220781438
    37500 TABLET, FILM COATED in 1 POUCH (62207-814-38)
  • ndc11
    6220781439
    7500 TABLET, FILM COATED in 1 POUCH (62207-814-39)
  • ndc11
    6220781447
    500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47)
  • ndc11
    6220781495
    1 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE

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.

All naproxen and diphenhydramine products

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/ec4b73f9-4c0f-4a91-b953-50d9e2de2245
GET /v1/drugs/ec4b73f9-4c0f-4a91-b953-50d9e2de2245?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": "62207-814",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA213663",
  "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.