MUCUS RELIEF DM

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5131667155
1 BOTTLE in 1 CARTON (51316-671-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5131667166
1 BOTTLE in 1 CARTON (51316-671-66) / 14 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": {
    "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": "51316-671_cb1daa23-e906-4a3f-b3d5-82fe1bef6b35",
  "productndc": "51316-671",
  "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": "MUCUS RELIEF DM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207602",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextromethorphan hydrobromide, guaifenesin",
  "start_marketing_date": "20251217",
  "active_numerator_strength": "60; 1200"
}

Related drugs

Other records sharing ATC code R05DA.

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