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United States · US · US:0536-1449_b03262b9-358d-43e9-a55c-0ebe4d7934d0

Rugby Mucus Relief D

Orange BookUNIISPLATC R05CA

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

Identification

ManufacturerRugby Laboratories
CountryUS (United States)
ATC codeR05CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0536144921
    1 BLISTER PACK in 1 CARTON (0536-1449-21) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    0536144936
    2 BLISTER PACK in 1 CARTON (0536-1449-36) / 18 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": {
    "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": "0536-1449_b03262b9-358d-43e9-a55c-0ebe4d7934d0",
  "productndc": "0536-1449",
  "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": "Rugby Mucus Relief D",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "guaifenesin and pseudoephedrine hydrochloride",
  "start_marketing_date": "20250402",
  "active_numerator_strength": "600; 60"
}

Related drugs

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