Rugby Mucus Relief DM ER

Orange BookUNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRugby Laboratories

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0536144634
1 BOTTLE in 1 CARTON (0536-1446-34) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

9D2RTI9KYH

DEXTROMETHORPHAN HYDROBROMIDE

RxCUI 102490

Orange Book

A207602

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "50c46cf5-3e64-9e0f-e063-6294a90a2317": {
      "match": "brand_token",
      "title": "RUGBY ANTIFUNGAL (TOLNAFTATE AEROSOL, POWDER) AEROSOL, SPRAY [RUGBY LABORATORIES]",
      "spl_version": "2",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0536-1446_85c51626-6e2f-4117-a2e0-1e5111a43422",
  "productndc": "0536-1446",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207602",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;1.2GM",
        "product_no": "001",
        "approval_date": "Mar 5, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG;600MG",
        "product_no": "002",
        "approval_date": "Mar 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "Rugby Mucus Relief DM ER",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207602",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextromethorphan hydrobromide, guaifenesin",
  "start_marketing_date": "20250402",
  "active_numerator_strength": "30; 600"
}

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