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United States · US · US:59640-300_443896af-9405-49b3-ba5a-ecf380af4b9a

mucus relief d

Orange BookUNIISPLATC R05CA

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeR05CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5964030062
    4 BLISTER PACK in 1 CARTON (59640-300-62) / 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": {
    "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": "59640-300_443896af-9405-49b3-ba5a-ecf380af4b9a",
  "productndc": "59640-300",
  "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": "mucus relief d",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "guaifenesin, pseudoephedrine hydrochloride",
  "start_marketing_date": "20231130",
  "active_numerator_strength": "1200; 120"
}

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