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United States · US · US:63824-008_52d1138d-fffb-7c33-e063-6294a90ac171

Mucinex

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerReckitt Benckiser LLC
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 12

  • ndc11
    6382400815
    5 BLISTER PACK in 1 CARTON (63824-008-15) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400827
    4 BLISTER PACK in 1 CARTON (63824-008-27) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400832
    1 BLISTER PACK in 1 CARTON (63824-008-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400834
    2 BLISTER PACK in 1 CARTON (63824-008-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400836
    1 BLISTER PACK in 1 CARTON (63824-008-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400850
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-008-50)
  • ndc11
    6382400869
    3 BLISTER PACK in 1 CARTON (63824-008-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400872
    2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-72)
  • ndc11
    6382400874
    24 POUCH in 1 CARTON (63824-008-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-73)
  • ndc11
    6382400880
    4 BLISTER PACK in 1 CARTON (63824-008-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400886
    4 BLISTER PACK in 1 CARTON (63824-008-86) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382400892
    6 BLISTER PACK in 1 CARTON (63824-008-92) / 20 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": "63824-008_52d1138d-fffb-7c33-e063-6294a90ac171",
  "productndc": "63824-008",
  "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": "20120703",
  "active_numerator_strength": "600"
}

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