MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerCVS Pharmacy, Inc.

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5131606065
2 BLISTER PACK in 1 CARTON (51316-060-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

9D2RTI9KYH

DEXTROMETHORPHAN HYDROBROMIDE

RxCUI 102490

Orange Book

A206941

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": "51316-060_e462b81d-0d78-4f13-b047-35aef91b50c7",
  "productndc": "51316-060",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206941",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG;600MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;1.2GM",
        "product_no": "002",
        "approval_date": "Mar 17, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA206941",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin and Dextromethorphan HBr",
  "start_marketing_date": "20240401",
  "active_numerator_strength": "60; 1200"
}

Related drugs

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