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United States · US · US:63824-057_52d12ac7-93cd-3f6b-e063-6294a90aaa02

Mucinex D

Orange BookUNIISPLATC R05CA

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

Identification

ManufacturerReckitt Benckiser LLC
CountryUS (United States)
ATC codeR05CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6382405718
    1 BLISTER PACK in 1 CARTON (63824-057-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382405736
    4 BLISTER PACK in 1 CARTON (63824-057-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
N021585
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": "63824-057_52d12ac7-93cd-3f6b-e063-6294a90aaa02",
  "productndc": "63824-057",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021585",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "600MG;60MG",
        "product_no": "001",
        "approval_date": "Jun 22, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.2GM;120MG",
        "product_no": "002",
        "approval_date": "Jun 22, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Mucinex D",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021585",
  "marketing_category": "NDA",
  "nonproprietary_name": "Guaifenesin and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20120626",
  "active_numerator_strength": "600; 60"
}

Related drugs

Other records sharing ATC code R05CA.

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