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United States · US · US:0536-1249_3b5fbc86-cb0e-468d-e063-6394a90a811f

Mucus Relief ER

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerRugby Laboratories
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0536124971
    2 BLISTER PACK in 1 CARTON (0536-1249-71) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A217780
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": {
    "84b5d83d-aea5-42ed-b20c-96d3b389c8c0": {
      "match": "brand_token",
      "title": "MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RITE AID CORPORATION]",
      "spl_version": "3",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0536-1249_3b5fbc86-cb0e-468d-e063-6394a90a811f",
  "productndc": "0536-1249",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217780",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Aug 21, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "Aug 21, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Mucus Relief ER",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217780",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20250421",
  "active_numerator_strength": "1200"
}

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