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United States · US · US:84324-034_e4832528-9f83-4a91-9c15-e8723e045187

Mucus Relief

Orange BookUNIISPLATC R05CA03

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

Identification

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

Packs · 1

  • ndc11
    8432403401
    24 TABLET, EXTENDED RELEASE in 1 BOTTLE (84324-034-01)

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
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": "84324-034_e4832528-9f83-4a91-9c15-e8723e045187",
  "productndc": "84324-034",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213420",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Mucus Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213420",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20251204",
  "active_numerator_strength": "1200"
}

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