Maximum Strength Guaifenesin DM

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerRugby Laboratories

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0536121388
14 BLISTER PACK in 1 CARTON (0536-1213-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

9D2RTI9KYH

DEXTROMETHORPHAN HYDROBROMIDE

RxCUI 102490

Orange Book

A209692

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": {
    "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": "0536-1213_74767680-e4e7-4ba6-8d45-a01cd0471317",
  "productndc": "0536-1213",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209692",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG;600MG",
        "product_no": "001",
        "approval_date": "Nov 1, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;1.2GM",
        "product_no": "002",
        "approval_date": "Nov 1, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "Maximum Strength Guaifenesin DM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA209692",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin, Dextromethorphan HBr",
  "start_marketing_date": "20181105",
  "active_numerator_strength": "60; 1200"
}

Related drugs

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