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United States · US · US:56062-614_6e895cf0-1ff9-464a-b315-49c0cab394fb

nasal and chest decongestant

Orange BookUNIISPLATC R05CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPublix Super Markets Inc
CountryUS (United States)
ATC codeR05CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5606261462
    4 BLISTER PACK in 1 CARTON (56062-614-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A214407
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "495W7451VQ",
    "rxcui": "5032",
    "inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
    "display_name": "GUAIFENESIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0ae25bc9-5d90-4dd8-9620-8684c4fd9d37": {
      "match": "brand_token",
      "title": "NASAL ALLERGY (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [RUGBY LABORATORIES]",
      "spl_version": "5",
      "published_date": "2026-05-25"
    }
  },
  "productid": "56062-614_6e895cf0-1ff9-464a-b315-49c0cab394fb",
  "productndc": "56062-614",
  "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG;60MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM;120MG",
        "product_no": "002",
        "approval_date": "Feb 1, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "nasal and chest decongestant",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "guaifenesin, pseudoephedrine hydrochloride",
  "start_marketing_date": "20260402",
  "active_numerator_strength": "1200; 120"
}

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