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United States · US · US:51316-970_a47d8036-88c3-4b04-b257-90e65d2ce922

MAXIMUM STRENGTH Mucus D

Orange BookUNIISPLATC R05CA

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

Identification

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

Packs · 1

  • ndc11
    5131697024
    1 BLISTER PACK in 1 CARTON (51316-970-24) / 24 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A212542
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": {
    "350764de-7801-b24e-e063-6394a90ab3c3": {
      "match": "brand_token",
      "title": "MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, GUAIFENESIN) TABLET, FILM COATED [RECKITT BENCKISER LLC]",
      "spl_version": "2",
      "published_date": "2026-05-15"
    }
  },
  "productid": "51316-970_a47d8036-88c3-4b04-b257-90e65d2ce922",
  "productndc": "51316-970",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212542",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG;60MG",
        "product_no": "001",
        "approval_date": "Apr 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM;120MG",
        "product_no": "002",
        "approval_date": "Apr 28, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "MAXIMUM STRENGTH Mucus D",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA212542",
  "marketing_category": "ANDA",
  "nonproprietary_name": "guaifenesin and pseudoephedrine hydrochloride",
  "start_marketing_date": "20220810",
  "active_numerator_strength": "1200; 120"
}

Related drugs

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