Back to search
🇺🇸

United States · US · US:55154-4680_4bf12228-02c0-4ad2-9335-c57529ec6cf7

Mucinex

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515446800
    10 BLISTER PACK in 1 BAG (55154-4680-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
N021282
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": {
    "49f1f415-8017-0974-e063-6294a90a8918": {
      "match": "brand_token",
      "title": "MUCINEX 12HR COLD AND FEVER MULTI-SYMPTOM (NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "55154-4680_4bf12228-02c0-4ad2-9335-c57529ec6cf7",
  "productndc": "55154-4680",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021282",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Jul 12, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "Dec 18, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Mucinex",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021282",
  "marketing_category": "NDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20160101",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code R05CA03.

Access this data programmatically

Query Mucinex and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.