United States· US:71179-816_ed5a625e-a3a7-4d6a-83fd-78de2a2473b8

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS

A antiinflammatory products for vaginal administration product containing naproxen sodium and pseudoephedrine hydrochloride, registered in United States by VESPYR BRANDS LLC.

ATC G02CCOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Naproxen Sodium and Pseudoephedrine Hydrochloride
Manufacturer: VESPYR BRANDS LLC
Country: United States (US)
ATC code: G02CC
ATC class: Antiinflammatory products for vaginal administration
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 1

ndc11
7117981624
3 BLISTER PACK in 1 CARTON (71179-816-24) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)

9TN87S3A3C

NAPROXEN SODIUM

RxCUI 142442

Orange Book

A211360

DailyMed SPL labels

1 version tracked

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/bc2d64e6-8892-47e5-8744-aed958b51334
GET /v1/drugs/bc2d64e6-8892-47e5-8744-aed958b51334?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.

{
  "unii": {
    "unii": "9TN87S3A3C",
    "rxcui": "142442",
    "inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
    "display_name": "NAPROXEN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c5146d73-2f34-4dfe-ac29-97071279dc4d": {
      "match": "brand_token",
      "title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71179-816_ed5a625e-a3a7-4d6a-83fd-78de2a2473b8",
  "productndc": "71179-816",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211360",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG;120MG",
        "product_no": "001",
        "approval_date": "Jun 1, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20240807",
  "active_numerator_strength": "220; 120"
}

API reference MCP server Plans

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